Gout Attack
Conditions
Keywords
hyperuricemia, acute arthritis, gouty arthritis, gout
Brief summary
The primary goal of the study was to evaluate the parameters of efficacy, pharmacokinetics, pharmacodynamics, safety and tolerability of a single dose of RPH-104 in adult patients with acute gout attack.
Detailed description
The study consisted of two periods: Period 1. In Study Period 1, eligible patients were enrolled in a group of 22 patients and randomized to receive either RPH-104 4 mg or Voltaren® (diclofenac) in the 15:7 ratio (15 RPH-104: 7 Voltaren® (diclofenac)). In order to prevent damage to the gastric and duodenal mucosa caused by Voltaren® (diclofenac), all patients receiving Voltaren® (diclofenac) had to simultaneously take Ortanol® (omeprazole) 20 mg, orally (1 capsule) daily before breakfast throughout the course of Voltaren® (diclofenac) treatment Period 2. Upon completion of the enrollment of 22 patients, Study Period 2 started. In Period 2, newly enrolled patients were randomly assigned to one of 5 treatment groups: RPH-104 20 mg, 40 mg, 80 mg and 160 mg and active control (Voltaren® (diclofenac)). It was planned to include 14 patients in the RPH-104 groups in Period 2, and 7 patients in the Voltaren® (diclofenac) group. The enrollment of patients in Period 1 and Period 2 was sequential. There was no pause between the enrollment of patients in Period 1 and Period 2. The study design included screening (24 hours), 11 visits to the study site, and a phone call at the end of the 60-day follow-up period. Total number of patients which were planned to be enrolled for the study: 85 (15 patients in the group of treatment with RPH-104 4 mg and 14 patients in the each of the other treatment groups). Due to the low patient recruitment rate in the study and the negative impact of the COVID-19 pandemic on the recruitment, at the decision of the sponsor, an interim analysis of the data of 47 patients included in the study as of November 2020 was carried out in order to assess the feasibility of continuing recruitment and further conducting the study. Patients who did not tolerate pain were allowed to receive a rescue medication, triamcinolone acetonide 40 mg intramuscularly, to intensify therapy 2 hours after the test product was administered. If the attack recurred after the use of the rescue medication, treatment was carried out in accordance with the standard practice of the hospital. The primary efficacy endpoints were evaluated 72 hours after the end of administration of the test drug. The secondary efficacy endpoints were evaluated for 45 days of the treatment period and follow-up. The safety parameters were evaluated for 60 days of the treatment period and follow-up. Total duration of the study for a volunteer was not more than 70 days.
Interventions
DRUGRPH - 104
solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL glass vial
DRUGVoltaren®
Enteric-coated tablets, 25 mg and 50 mg
Sponsors
Covance
Unimed Laboratories
Data Matrix Solutions
Center of Pharmaceutical Analytics LLC
OCT LLC
R-Pharm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 1\. The subject has given his / her informed consent to participate in this study; the Informed Consent Form has been signed both by the patient and the Investigator; * 2\. Established diagnosis of gout according to Gout Classification Criteria established by the American College of Rheumatology (ACR) and European League against Rheumatism (EULAR) in 2015; * 3\. Pain in at least one joint at the screening and immediately prior to initiation of therapy with the study drugs, with intensity 50 mm to 100 mm according to the Visual Analogue Scale (VAS); * 4\. Development of acute gout attack within 120 hours (5 days) prior to the randomization date; * 5\. History of 1 or more acute gout attacks prior to the Screening Visit; * 6.The patients receiving uric acid-lowering drugs should continue receiving these drugs at a constant dose for at least 4 weeks prior to enrolment to the study and throughout the entire study period; the patients not receiving uric acid-lowering drugs may start receiving this treatment after the end of the study; * 7\. Body mass index ≤40 kg/m2; * 8\. QTcF interval ≤450 msec for male subjects and ≤470 msec for females on ECG at the screening; * 9\. For women of child-bearing potential: negative result of the serum pregnancy test performed at the screening; * 10\. The consent of a woman of child-bearing potential, as well as of a man who has female partners of child-bearing potential, to abstain from sexual intercourses or to use effective birth control methods throughout the entire study period and for 60 days after RPH-104 administration (if the patient received RPH-104); * 11\. The patient is able to fulfil the requirements of the Study Protocol as judged by the Investigator
Exclusion criteria
* 1\. The patient received therapy with ibuprofen in a dose of up to 400 mg inclusive within 4 hours or \>400 mg within 8 hours prior to randomization. * 2\. The patient received therapy with diclofenac in a dose of up to 50 mg inclusive within 8 hours or \>50 mg within 24 hours prior to randomization. * 3\. The patient received any other non-steroidal anti-inflammatory drug (NSAID) within 24 hours prior to the randomization; * 4.The patient received opioids within 48 hours prior to the randomization; * 5\. The patient received metamizole or metamizole-containing drugs within 12 hours prior to the randomization; * 6\. The patient received any drug with analgesic activity (including paracetamol) within 6 hours prior to the randomization; * 7\. The patient received a long-acting NSAID (half-life ≥24 hours) within 5 half-life periods or 1 month prior to the randomization whichever is longer; * 8\. The patient received extended-release naproxen, meloxicam, nabumetone, celecoxib, etoricoxib or indomethacin within 5 days prior to the randomization; * 9 . The patient received corticosteroids (including their intra-articular administration and inhalations) within 4 weeks prior to the randomization; * 10\. The patient received colchicine within 7 days prior to the randomization; * 11\. Intolerance or contraindications for NSAID use; * 12\. Contraindications for the use of Ortanol® capsules 20 mg; * 13\. Chronic heart failure functional class II-IV (classification of NYHA); * 14\. A history of or current clinically significant ventricular arrhythmias or clinically significant atrial tachyarrhythmias; * 15\. Unstable angina or stable exercise-induced angina of functional class III or IV; * 16\. Secondary gout, chemotherapy-induced gout, lead- or transplantation-induced gout; * 17\. Rheumatoid arthritis, confirmed or suspected infectious septic arthritis or any other type of acute inflammatory arthritis; * 18\. Clinically significant renal impairment determined based on creatinine clearance (estimated using the Cockcroft-Gault equation) \<60 mL/min, or patients on hemodialysis; * 19\. Blood coagulation disorders; history of gastrointestinal bleedings or perforation; * 20\. Pregnant or breast-feeding women; * 21\. Elective surgery or major surgical intervention (minor surgical procedures, such as catheter placement or bone marrow biopsy, are not
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity in the Assessed Joint 72 Hours After the Initiation of Treatment in Comparison to Baseline | Baseline and Day 4 (72 hours after the initiation of treatment with the test drug) | Change in pain intensity in the assessed joint 72 hours after the initiation of treatment with the test drug measured using the Visual Analogue Scale (VAS) in comparison to baseline. VAS is a hard copy 100 mm scale with the indications: Absence of pain on the left side of the scale (0 mm point) and The most severe pain ever experienced on the right side of the scale (100 mm point)) The better outcome would be Absence of pain, the worse outcome would be The most severe pain ever experienced. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | 15, 30, 45 minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 after the initiation of treatment with the test drug | Proportion of patients who assessed the response to therapy with the test drug as Excellent or Good in 15, 30, 45 minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug. The patient's response to therapy was assessed in the form of frequency tables by assessment point and therapy group. The rates of the response were specified in the evaluation form as: Excellent, Good, Fair, Weak, Poor (where excellent represents the best possible response to treatment and poor indicates the worst treatment response). |
| Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Baseline and 15, 30, 45 minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 after the initiation of treatment | Change in pain intensity in the assessed joint in 15, 30, 45 minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug measured using the Visual Analogue Scale (VAS) and compared to baseline. VAS is a hard copy 100 mm scale with the indications: Absence of pain on the left side of the scale (0 mm point) and The most severe pain ever experienced on the right side of the scale (100 mm point)) The better outcome would be Absence of pain, the worse outcome would be The most severe pain ever experienced. |
| Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline and 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug | Change in the rate of swelling of the assessed joint evaluated in 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug compared to baseline. The rates of swelling were specified in the evaluation form as: absence = no swelling, mild = palpable swelling, moderate = visible swelling, severe = bulging outside the joint (where severe represented the worst possible degree of swelling and absence was the best outcome). |
| Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline and 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug | Change in the rate of tenderness of the assessed joint evaluated in 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug compared to baseline. Tenderness degrees: absent = no tenderness, mild = tenderness when touched, moderate = pain and flinching, severe = pain, flinching and withdrawal of the limb (where severe represents the worst possible degree of tenderness and absent is the best outcome). |
| Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline and 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug | Change in the rate of erythema of the assessed joint evaluated in 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug compared to baseline.The rates of erythema were specified as absence, presence, impossible to evaluate. |
| Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline and in 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug | Change in the rate of movement restrictions in the assessed joint evaluated in 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug compared to baseline. For the assessment, the categorical scale consistent with the Form for evaluation (Investigator's Assessment) of the restriction of movements was used. The rates of movement restrictions (amplitude of movements) were specified in the evaluation form as 1 - Normal range, 2 - Slightly limited range, 3 - Moderately limited range ,4 - Severely limited range and 5 - Joint movement is impossible (where higher score means worse outcome). |
| Time to Achieve the 50% Decrease in Pain Intensity in the Assessed Joint Relative to the Baseline | Baseline and one of the pain intensity measurements in accordance with the schedule: 15, 30, 45 minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 after the initiation of treatment | Time to achieve the 50% decrease in pain intensity in the assessed joint relative to the baseline VAS level. VAS is a hard copy 100 mm scale with the indications: Absence of pain on the left side of the scale (0 mm point) and The most severe pain ever experienced on the right side of the scale (100 mm point)). The better outcome would be Absence of pain, the worse outcome would be The most severe pain ever experienced. |
| Time to Use of the Rescue Medication | from the date/time of IP administration (first dose) to the date/time of the first use of the rescue medication, up to day 60 | Time to use of the rescue medication was calculated as the time in hours from the date/time of administration (first dose) of the investigational product to the date/time of the first use of the rescue medication. |
| Proportion of Patients Who Received a Rescue Therapy Agent | 72 hours after the initiation of treatment with the test drug | The proportion of patients who received the rescue medication within 72 hours of starting the investigational product therapy |
| Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index | Baseline and 15, 29 and 45 days following the initiation of treatment with the test drug | Changes in the Health Assessment Questionnaire (HAQ) parameters in 15, 29 and 45 days following the initiation of treatment with the test drug as compared to baseline. (The result for each of the 8 categories (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, Activities) of the HAQ questionnaire was calculated as the maximum score of responses (on an ordinal scale from 0 (best) to 3 (worst): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3)) to questions included in this category. If the patient required outside help or any of the specified aids or devices to perform actions related to a certain category, then this category was assigned 2 points, if the point was not equal to 3, i.e. points 0 and 1 increased to 2. The sum of points for the evaluated categories was calculated and divided by the number of categories, which gives a disability index in the range of 0 to 3.) |
| Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising | Baseline and 15, 29 and 45 days following the initiation of treatment with the test drug | Changes in the Health Assessment Questionnaire (HAQ) parameters in 15, 29 and 45 days following the initiation of treatment with the test drug as compared to baseline. The result was calculated as the maximum score of responses (on an ordinal scale from 0 to 3) to questions included in this category. Patients were asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst). If the patient required outside help or any of the specified aids or devices to perform actions related to a certain category, then this category was assigned 2 points, if the point was not equal to 3, i.e. points 0 and 1 increased to 2. |
| Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating | Baseline and 15, 29 and 45 days following the initiation of treatment with the test drug | Changes in the Health Assessment Questionnaire (HAQ) parameters in 15, 29 and 45 days following the initiation of treatment with the test drug as compared to baseline. The result was calculated as the maximum score of responses (on an ordinal scale from 0 to 3) to questions included in this category. Patients were asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst). If the patient required outside help or any of the specified aids or devices to perform actions related to a certain category, then this category was assigned 2 points, if the point was not equal to 3, i.e. points 0 and 1 increased to 2. |
| Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking | Baseline and 15, 29 and 45 days following the initiation of treatment with the test drug | Changes in the Health Assessment Questionnaire (HAQ) parameters in 15, 29 and 45 days following the initiation of treatment with the test drug as compared to baseline. The result was calculated as the maximum score of responses (on an ordinal scale from 0 to 3) to questions included in this category. Patients were asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst). If the patient required outside help or any of the specified aids or devices to perform actions related to a certain category, then this category was assigned 2 points, if the point was not equal to 3, i.e. points 0 and 1 increased to 2. |
| Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene | Baseline and 15, 29 and 45 days following the initiation of treatment with the test drug | Changes in the Health Assessment Questionnaire (HAQ) parameters in 15, 29 and 45 days following the initiation of treatment with the test drug as compared to baseline. The result was calculated as the maximum score of responses (on an ordinal scale from 0 to 3) to questions included in this category. Patients were asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst). If the patient required outside help or any of the specified aids or devices to perform actions related to a certain category, then this category was assigned 2 points, if the point was not equal to 3, i.e. points 0 and 1 increased to 2. |
| Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip | Baseline and 15, 29 and 45 days following the initiation of treatment with the test drug | Changes in the Health Assessment Questionnaire (HAQ) parameters in 15, 29 and 45 days following the initiation of treatment with the test drug as compared to baseline. The result was calculated as the maximum score of responses (on an ordinal scale from 0 to 3) to questions included in this category. Patients were asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst). If the patient required outside help or any of the specified aids or devices to perform actions related to a certain category, then this category was assigned 2 points, if the point was not equal to 3, i.e. points 0 and 1 increased to 2. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) - Maximum Concentration of the Active Substance -of RPH-104 Under the Subcutaneous Administration | Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient) | Including Maximum concentration of the active substance (Cmax) |
| Pharmacokinetics (PK) of RPH-104 Under the Subcutaneous Administration | Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient) | Including elimination constant (Kel) |
| Pharmacokinetics (PK) -Time to Reach Maximum Concentration of the Active Substance - of RPH-104 Under the Subcutaneous Administration | Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient) | Including Time to reach maximum concentration of the active substance (tmax) |
| Pharmacokinetics (PK) - Terminal Half-life -of RPH-104 Under the Subcutaneous Administration | Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient) | Including terminal half-life (T 1/2) |
| Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Baseline and in 24, 72 hours, on Days 5, 6, 15, 29 and 45 after the initiation of treatment with the test drug | Change in the serum rate of high-sensitive CRP (hs-CRP) in 24, 72 hours, on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug compared to baseline |
| Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Baseline and in 24, 72 hours and on Day 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug | Change in the rate of serum amyloid protein A in 24, 72 hours and on Day 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline |
| Change in the Serum Rates of Cytokines: IL-1α | Baseline and in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug | Change in the serum rates of IL-1α in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline |
| Change in the Serum Rates of Cytokines: IL-1β | Baseline and in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug | Change in the serum rates of IL-1β in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline |
| Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Baseline and in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug | Change in the serum rates of IL-1RA in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline |
| Change in the Serum Rates of Cytokines: IL-6 | Baseline and in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug | Change in the serum rates of IL-6 in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline |
| Change in the Serum Rates of Cytokines: IL-8 | Baseline and in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug | Change in the serum rates of IL-8 in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline |
| Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Baseline and in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug | Change in the serum rates of TNF-α in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline |
| Pharmacokinetics (PK) - Area Under the Active Substance Concentration- of RPH-104 Under the Subcutaneous Administration | Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient) | Including Area under the active substance concentration-time curve from zero (before drug administration) to infinity (AUC0-∞) |
| Pharmacokinetics (PK) - Area Under the Plasma concentration-of RPH-104 Under the Subcutaneous Administration | Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient) | Including area under the plasma concentration-time curve over the dosing interval (AUC0-tau) |
Countries
Russia
Participant flow
Recruitment details
Enrollment was conducted at 11 clinical sites in Russian Federation. 54 subjects were screened and 47 subjects were enrolled (randomized) and treated, 44 subjects completed the study. The Safety Population and Efficacy Population included data from all 47 randomized patients to assess safety, treatment efficacy and pharmacodynamics.
Participants by arm
| Arm | Count |
|---|---|
| RPH - 4 mg RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected. | 15 |
| RPH - 20 mg RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected. | 6 |
| RPH - 40 mg RPH-104, 40 mg, subcutaneous single-dose injection.
1 mL of 40 mg/mL RPH-104 solution is injected. | 6 |
| RPH - 80 mg RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected. | 6 |
| RPH - 160 mg RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites.
1 vial of 2mL 40 mg/mL solution per each site | 5 |
| Voltaren® (Diclofenac) Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg) | 9 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | closure of city borders because of COVID-19 quarantine | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | COVID-19 epidemiological situation | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | RPH - 4 mg | RPH - 20 mg | RPH - 40 mg | RPH - 80 mg | RPH - 160 mg | Voltaren® (Diclofenac) | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 52.3 years | 51.7 years | 42.8 years | 56.5 years | 53.6 years | 52.2 years | 51.5 years |
| Disease duration | 8.13 years | 7.65 years | 8.04 years | 9.16 years | 13.55 years | 6.41 years | 8.82 years |
| Exact number of affected joints | 5.3 number (of joints) | 3.0 number (of joints) | 5.7 number (of joints) | 2.7 number (of joints) | 6.2 number (of joints) | 3.0 number (of joints) | 4.32 number (of joints) |
| Race/Ethnicity, Customized Race Caucasian/White | 15 Participants | 6 Participants | 6 Participants | 6 Participants | 5 Participants | 9 Participants | 47 Participants |
| Race/Ethnicity, Customized Race other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 15 Participants | 5 Participants | 6 Participants | 6 Participants | 5 Participants | 7 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 9 |
| other Total, other adverse events | 11 / 15 | 1 / 6 | 3 / 6 | 3 / 6 | 4 / 5 | 2 / 9 |
| serious Total, serious adverse events | 0 / 15 | 0 / 6 | 0 / 6 | 2 / 6 | 0 / 5 | 1 / 9 |
Outcome results
Primary
Change in Pain Intensity in the Assessed Joint 72 Hours After the Initiation of Treatment in Comparison to Baseline
Change in pain intensity in the assessed joint 72 hours after the initiation of treatment with the test drug measured using the Visual Analogue Scale (VAS) in comparison to baseline. VAS is a hard copy 100 mm scale with the indications: Absence of pain on the left side of the scale (0 mm point) and The most severe pain ever experienced on the right side of the scale (100 mm point)) The better outcome would be Absence of pain, the worse outcome would be The most severe pain ever experienced.
Time frame: Baseline and Day 4 (72 hours after the initiation of treatment with the test drug)
Population: The baseline observation carried forward method (BOCF) was used to impute missing data for the main efficacy analysis. Missing patient data were replaced with baseline values from the time of patient discontinuation or use of the rescue medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| RPH - 4 mg | Change in Pain Intensity in the Assessed Joint 72 Hours After the Initiation of Treatment in Comparison to Baseline | -7.88 mm (VAS scale) |
| RPH - 20 mg | Change in Pain Intensity in the Assessed Joint 72 Hours After the Initiation of Treatment in Comparison to Baseline | -38.56 mm (VAS scale) |
| RPH - 40 mg | Change in Pain Intensity in the Assessed Joint 72 Hours After the Initiation of Treatment in Comparison to Baseline | -19.80 mm (VAS scale) |
| RPH - 80 mg | Change in Pain Intensity in the Assessed Joint 72 Hours After the Initiation of Treatment in Comparison to Baseline | -33.39 mm (VAS scale) |
| RPH - 160 mg | Change in Pain Intensity in the Assessed Joint 72 Hours After the Initiation of Treatment in Comparison to Baseline | -30.55 mm (VAS scale) |
| Voltaren® (Diclofenac) | Change in Pain Intensity in the Assessed Joint 72 Hours After the Initiation of Treatment in Comparison to Baseline | -36.51 mm (VAS scale) |
Comparison: It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.p-value: 0.133195% CI: [4.21, 53.05]ANCOVA
Comparison: It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.p-value: 0.133195% CI: [-30.6, 26.5]ANCOVA
Comparison: It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.p-value: 0.133195% CI: [-12.67, 46.08]ANCOVA
Comparison: It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.p-value: 0.133195% CI: [-25.1, 31.33]ANCOVA
Comparison: It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.p-value: 0.133195% CI: [-24.22, 36.14]ANCOVA
Secondary
Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline
Change in pain intensity in the assessed joint in 15, 30, 45 minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug measured using the Visual Analogue Scale (VAS) and compared to baseline. VAS is a hard copy 100 mm scale with the indications: Absence of pain on the left side of the scale (0 mm point) and The most severe pain ever experienced on the right side of the scale (100 mm point)) The better outcome would be Absence of pain, the worse outcome would be The most severe pain ever experienced.
Time frame: Baseline and 15, 30, 45 minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 after the initiation of treatment
Population: The baseline observation carried forward method (BOCF) was used to impute missing data for the main efficacy analysis. Missing patient data were replaced with baseline values from the time of patient discontinuation or use of the rescue medication.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| RPH - 4 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/15 minutes | -2.00 mm (VAS scale) |
| RPH - 4 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 4 hours | -21.87 mm (VAS scale) |
| RPH - 4 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 45 | -2.60 mm (VAS scale) |
| RPH - 4 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 2 hours | -22.07 mm (VAS scale) |
| RPH - 4 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 1 hour | -19.67 mm (VAS scale) |
| RPH - 4 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 6 | -4.80 mm (VAS scale) |
| RPH - 4 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 18 | -4.07 mm (VAS scale) |
| RPH - 4 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 8 hours | -14.20 mm (VAS scale) |
| RPH - 4 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 5 | -4.73 mm (VAS scale) |
| RPH - 4 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 2 | -10.60 mm (VAS scale) |
| RPH - 4 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 1.5 hours | -22.47 mm (VAS scale) |
| RPH - 4 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 4 | -6.67 mm (VAS scale) |
| RPH - 4 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 15 | -4.13 mm (VAS scale) |
| RPH - 4 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 3 | -3.33 mm (VAS scale) |
| RPH - 4 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/30 minutes | -10.00 mm (VAS scale) |
| RPH - 4 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 22 | -3.20 mm (VAS scale) |
| RPH - 4 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 10 | -6.73 mm (VAS scale) |
| RPH - 4 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 29 | -4.07 mm (VAS scale) |
| RPH - 4 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/45 minutes | -16.20 mm (VAS scale) |
| RPH - 20 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 3 | -35.77 mm (VAS scale) |
| RPH - 20 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/15 minutes | -6.97 mm (VAS scale) |
| RPH - 20 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 6 | -34.44 mm (VAS scale) |
| RPH - 20 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 4 | -38.77 mm (VAS scale) |
| RPH - 20 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 5 | -31.27 mm (VAS scale) |
| RPH - 20 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 29 | -44.94 mm (VAS scale) |
| RPH - 20 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 45 | -46.94 mm (VAS scale) |
| RPH - 20 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/45 minutes | -16.14 mm (VAS scale) |
| RPH - 20 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 1 hour | -15.81 mm (VAS scale) |
| RPH - 20 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/30 minutes | -14.16 mm (VAS scale) |
| RPH - 20 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 22 | -44.61 mm (VAS scale) |
| RPH - 20 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 1.5 hours | -15.14 mm (VAS scale) |
| RPH - 20 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 18 | -42.61 mm (VAS scale) |
| RPH - 20 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 2 hours | -25.14 mm (VAS scale) |
| RPH - 20 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 4 hours | -27.27 mm (VAS scale) |
| RPH - 20 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 15 | -41.77 mm (VAS scale) |
| RPH - 20 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 8 hours | -29.61 mm (VAS scale) |
| RPH - 20 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 10 | -37.27 mm (VAS scale) |
| RPH - 20 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 2 | -37.77 mm (VAS scale) |
| RPH - 40 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 29 | -13.58 mm (VAS scale) |
| RPH - 40 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 15 | -12.41 mm (VAS scale) |
| RPH - 40 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/45 minutes | -7.91 mm (VAS scale) |
| RPH - 40 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 2 | -20.94 mm (VAS scale) |
| RPH - 40 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 4 hours | -21.44 mm (VAS scale) |
| RPH - 40 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/30 minutes | -6.43 mm (VAS scale) |
| RPH - 40 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/15 minutes | -5.91 mm (VAS scale) |
| RPH - 40 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 45 | -13.58 mm (VAS scale) |
| RPH - 40 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 5 | -13.64 mm (VAS scale) |
| RPH - 40 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 4 | -18.91 mm (VAS scale) |
| RPH - 40 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 8 hours | -18.93 mm (VAS scale) |
| RPH - 40 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 10 | -12.43 mm (VAS scale) |
| RPH - 40 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 1.5 hours | -21.26 mm (VAS scale) |
| RPH - 40 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 18 | -12.74 mm (VAS scale) |
| RPH - 40 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 6 | -12.43 mm (VAS scale) |
| RPH - 40 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 1 hour | -11.76 mm (VAS scale) |
| RPH - 40 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 22 | -13.58 mm (VAS scale) |
| RPH - 40 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 3 | -27.94 mm (VAS scale) |
| RPH - 40 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 2 hours | -24.63 mm (VAS scale) |
| RPH - 80 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 22 | -12.69 mm (VAS scale) |
| RPH - 80 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 8 hours | -16.52 mm (VAS scale) |
| RPH - 80 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/15 minutes | -1.52 mm (VAS scale) |
| RPH - 80 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/30 minutes | -5.19 mm (VAS scale) |
| RPH - 80 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/45 minutes | -9.36 mm (VAS scale) |
| RPH - 80 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 1 hour | -12.52 mm (VAS scale) |
| RPH - 80 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 1.5 hours | -14.69 mm (VAS scale) |
| RPH - 80 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 2 hours | -13.86 mm (VAS scale) |
| RPH - 80 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 4 hours | -14.36 mm (VAS scale) |
| RPH - 80 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 2 | -25.52 mm (VAS scale) |
| RPH - 80 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 3 | -34.69 mm (VAS scale) |
| RPH - 80 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 4 | -34.52 mm (VAS scale) |
| RPH - 80 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 5 | -35.86 mm (VAS scale) |
| RPH - 80 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 6 | -22.86 mm (VAS scale) |
| RPH - 80 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 10 | -23.52 mm (VAS scale) |
| RPH - 80 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 15 | -12.69 mm (VAS scale) |
| RPH - 80 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 18 | -12.69 mm (VAS scale) |
| RPH - 80 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 29 | -12.69 mm (VAS scale) |
| RPH - 80 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 45 | -12.69 mm (VAS scale) |
| RPH - 160 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 18 | -29.75 mm (VAS scale) |
| RPH - 160 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 6 | -29.15 mm (VAS scale) |
| RPH - 160 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 1 hour | -15.99 mm (VAS scale) |
| RPH - 160 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 4 hours | -20.35 mm (VAS scale) |
| RPH - 160 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 2 hours | -19.59 mm (VAS scale) |
| RPH - 160 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 22 | -28.35 mm (VAS scale) |
| RPH - 160 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/30 minutes | -10.57 mm (VAS scale) |
| RPH - 160 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 15 | -28.95 mm (VAS scale) |
| RPH - 160 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/15 minutes | -5.75 mm (VAS scale) |
| RPH - 160 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 8 hours | -25.35 mm (VAS scale) |
| RPH - 160 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 45 | -19.75 mm (VAS scale) |
| RPH - 160 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 29 | -17.95 mm (VAS scale) |
| RPH - 160 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/45 minutes | -11.77 mm (VAS scale) |
| RPH - 160 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 1.5 hours | -17.79 mm (VAS scale) |
| RPH - 160 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 5 | -31.35 mm (VAS scale) |
| RPH - 160 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 10 | -29.15 mm (VAS scale) |
| RPH - 160 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 4 | -30.75 mm (VAS scale) |
| RPH - 160 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 3 | -30.15 mm (VAS scale) |
| RPH - 160 mg | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 2 | -30.35 mm (VAS scale) |
| Voltaren® (Diclofenac) | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 2 | -30.34 mm (VAS scale) |
| Voltaren® (Diclofenac) | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 6 | -42.45 mm (VAS scale) |
| Voltaren® (Diclofenac) | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 8 hours | -25.67 mm (VAS scale) |
| Voltaren® (Diclofenac) | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 10 | -37.78 mm (VAS scale) |
| Voltaren® (Diclofenac) | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 4 hours | -22.67 mm (VAS scale) |
| Voltaren® (Diclofenac) | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 15 | -38.34 mm (VAS scale) |
| Voltaren® (Diclofenac) | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 1.5 hours | -13.67 mm (VAS scale) |
| Voltaren® (Diclofenac) | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 1 hour | -12.67 mm (VAS scale) |
| Voltaren® (Diclofenac) | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 45 | -23.34 mm (VAS scale) |
| Voltaren® (Diclofenac) | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 18 | -28.45 mm (VAS scale) |
| Voltaren® (Diclofenac) | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/45 minutes | -8.56 mm (VAS scale) |
| Voltaren® (Diclofenac) | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/15 minutes | -3.78 mm (VAS scale) |
| Voltaren® (Diclofenac) | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 22 | -30.34 mm (VAS scale) |
| Voltaren® (Diclofenac) | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/30 minutes | -5.45 mm (VAS scale) |
| Voltaren® (Diclofenac) | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 3 | -38.67 mm (VAS scale) |
| Voltaren® (Diclofenac) | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 4 | -38.12 mm (VAS scale) |
| Voltaren® (Diclofenac) | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 29 | -23.89 mm (VAS scale) |
| Voltaren® (Diclofenac) | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 5 | -42.78 mm (VAS scale) |
| Voltaren® (Diclofenac) | Change in Pain Intensity in the Assessed Joint in 15, 30, 45 Minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 Hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 Following the Initiation of Treatment and Compared to Baseline | Day 1/ 2 hours | -20.56 mm (VAS scale) |
Secondary
Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug
Change in the rate of erythema of the assessed joint evaluated in 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug compared to baseline.The rates of erythema were specified as absence, presence, impossible to evaluate.
Time frame: Baseline and 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug
Population: It should be noted that estimates following the use of the rescue medication or a prohibited analgesic were not included in the descriptive statistics, therefore, the number of patients with analyzable data in treatment groups decreased over time.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | evaluation impossible | 0 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | absence | 1 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | presence | 0 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | evaluation impossible | 0 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | absence | 2 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | evaluation impossible | 0 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | presence | 0 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | evaluation impossible | 0 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | absence | 2 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | presence | 0 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | presence | 0 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | evaluation impossible | 0 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | absence | 2 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | presence | 7 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | presence | 0 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | presence | 0 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | evaluation impossible | 0 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | presence | 0 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | absence | 3 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | evaluation impossible | 0 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | absence | 1 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | absence | 1 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | absence | 2 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | absence | 1 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | presence | 0 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | absence | 2 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | presence | 12 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | evaluation impossible | 0 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | presence | 0 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | absence | 5 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | evaluation impossible | 0 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | evaluation impossible | 0 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | evaluation impossible | 0 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | presence | 0 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | evaluation impossible | 0 Participants |
| RPH - 4 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | absence | 1 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | evaluation impossible | 0 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | evaluation impossible | 0 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | absence | 4 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | absence | 3 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | evaluation impossible | 0 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | presence | 0 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | presence | 0 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | evaluation impossible | 0 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | evaluation impossible | 0 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | absence | 4 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | presence | 1 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | absence | 4 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | absence | 4 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | presence | 0 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | presence | 3 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | absence | 2 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | absence | 0 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | presence | 0 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | evaluation impossible | 0 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | evaluation impossible | 0 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | absence | 4 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | presence | 0 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | absence | 3 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | evaluation impossible | 0 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | presence | 1 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | presence | 0 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | presence | 0 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | absence | 3 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | evaluation impossible | 0 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | absence | 3 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | evaluation impossible | 0 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | absence | 4 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | evaluation impossible | 0 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | presence | 1 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | presence | 6 Participants |
| RPH - 20 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | evaluation impossible | 0 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | evaluation impossible | 0 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | presence | 0 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | evaluation impossible | 0 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | presence | 0 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | presence | 0 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | presence | 4 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | evaluation impossible | 1 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | absence | 0 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | absence | 2 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | presence | 2 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | evaluation impossible | 1 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | presence | 2 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | evaluation impossible | 0 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | evaluation impossible | 0 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | presence | 6 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | presence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | presence | 0 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | evaluation impossible | 0 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | presence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | evaluation impossible | 0 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | evaluation impossible | 0 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | presence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | evaluation impossible | 0 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | evaluation impossible | 0 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | presence | 0 Participants |
| RPH - 40 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | evaluation impossible | 0 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | evaluation impossible | 0 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | evaluation impossible | 0 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | evaluation impossible | 0 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | absence | 1 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | absence | 3 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | evaluation impossible | 0 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | presence | 0 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | absence | 2 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | evaluation impossible | 1 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | presence | 0 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | evaluation impossible | 0 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | presence | 1 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | absence | 1 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | presence | 0 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | presence | 0 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | absence | 0 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | absence | 3 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | absence | 1 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | absence | 1 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | evaluation impossible | 0 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | presence | 0 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | evaluation impossible | 0 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | presence | 4 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | absence | 1 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | evaluation impossible | 0 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | absence | 2 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | evaluation impossible | 0 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | presence | 0 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | presence | 0 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | presence | 5 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | absence | 1 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | presence | 0 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | absence | 3 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | evaluation impossible | 0 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | presence | 0 Participants |
| RPH - 80 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | evaluation impossible | 0 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | absence | 1 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | absence | 0 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | presence | 5 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | evaluation impossible | 0 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | absence | 2 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | presence | 2 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | evaluation impossible | 0 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | absence | 1 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | presence | 2 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | evaluation impossible | 0 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | absence | 2 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | presence | 1 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | evaluation impossible | 0 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | absence | 3 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | presence | 0 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | evaluation impossible | 0 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | absence | 3 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | presence | 0 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | evaluation impossible | 0 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | absence | 3 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | presence | 0 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | evaluation impossible | 0 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | absence | 3 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | presence | 0 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | evaluation impossible | 0 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | absence | 3 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | presence | 0 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | evaluation impossible | 0 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | absence | 2 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | presence | 0 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | evaluation impossible | 0 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | presence | 0 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | evaluation impossible | 0 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | absence | 1 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | presence | 0 Participants |
| RPH - 160 mg | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | evaluation impossible | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | presence | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | absence | 6 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | presence | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | evaluation impossible | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | evaluation impossible | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | presence | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | absence | 4 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | evaluation impossible | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | absence | 4 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | presence | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | absence | 7 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | evaluation impossible | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | presence | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | absence | 7 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | presence | 7 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | evaluation impossible | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | presence | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | absence | 7 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | absence | 2 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | evaluation impossible | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | evaluation impossible | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | presence | 2 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | absence | 5 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | evaluation impossible | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | evaluation impossible | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | absence | 4 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | presence | 6 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | absence | 2 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | evaluation impossible | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | absence | 2 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | evaluation impossible | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | presence | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | presence | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | presence | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | absence | 2 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Erythema of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | evaluation impossible | 0 Participants |
Secondary
Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment
Change in the rate of movement restrictions in the assessed joint evaluated in 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug compared to baseline. For the assessment, the categorical scale consistent with the Form for evaluation (Investigator's Assessment) of the restriction of movements was used. The rates of movement restrictions (amplitude of movements) were specified in the evaluation form as 1 - Normal range, 2 - Slightly limited range, 3 - Moderately limited range ,4 - Severely limited range and 5 - Joint movement is impossible (where higher score means worse outcome).
Time frame: Baseline and in 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug
Population: It should be noted that estimates following the use of the rescue medication or a prohibited analgesic were not included in the descriptive statistics, therefore, the number of patients with analyzable data in treatment groups decreased over time.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 3 | 1 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 1 | 1 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 1 | 1 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 5 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 2 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 3 | 1 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 4 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 3 | 1 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 2 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 1 | 1 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 5 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 5 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 4 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 2 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 1 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 4 | 3 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 5 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 2 | 1 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 4 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 5 | 1 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 1 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 5 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 1 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 1 | 1 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 4 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 2 | 1 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 5 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 4 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 4 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 3 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 4 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 4 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 3 | 1 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 5 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 2 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 4 | 9 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 3 | 1 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 1 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 4 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 3 | 1 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 1 | 1 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 1 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 2 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 5 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 3 | 5 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 3 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 2 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 2 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 3 | 7 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 3 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 2 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 5 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 5 | 1 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 1 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 2 | 1 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 2 | 1 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 4 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 1 | 1 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 5 | 0 Participants |
| RPH - 4 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 3 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 1 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 3 | 3 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 2 | 1 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 1 | 3 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 5 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 2 | 1 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 4 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 1 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 5 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 4 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 3 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 1 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 3 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 2 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 3 | 2 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 2 | 1 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 4 | 4 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 5 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 1 | 3 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 5 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 1 | 3 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 5 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 2 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 2 | 1 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 5 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 1 | 3 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 3 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 1 | 2 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 2 | 3 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 5 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 5 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 4 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 1 | 3 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 3 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 4 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 3 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 3 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 5 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 2 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 4 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 1 | 3 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 4 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 5 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 2 | 1 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 5 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 3 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 4 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 4 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 3 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 5 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 2 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 2 | 5 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 1 | 3 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 1 | 3 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 4 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 3 | 1 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 3 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 4 | 1 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 4 | 0 Participants |
| RPH - 20 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 2 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 3 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 5 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 2 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 5 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 4 | 2 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 5 | 1 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 1 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 2 | 2 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 3 | 1 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 4 | 1 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 5 | 1 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 1 | 1 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 2 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 3 | 1 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 4 | 1 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 5 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 1 | 1 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 2 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 3 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 4 | 1 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 3 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 3 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 4 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 5 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 5 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 1 | 1 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 2 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 3 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 1 | 1 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 2 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 3 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 4 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 5 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 5 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 1 | 1 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 2 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 3 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 4 | 1 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 4 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 1 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 4 | 5 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 1 | 1 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 2 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 1 | 1 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 4 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 5 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 5 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 4 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 2 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 2 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 2 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 4 | 1 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 3 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 2 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 5 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 1 | 1 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 3 | 1 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 1 | 0 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 3 | 3 Participants |
| RPH - 40 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 1 | 1 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 2 | 2 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 2 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 3 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 5 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 3 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 4 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 4 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 1 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 2 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 3 | 3 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 4 | 2 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 5 | 1 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 1 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 3 | 2 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 5 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 5 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 1 | 1 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 2 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 1 | 1 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 3 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 4 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 4 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 4 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 3 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 1 | 1 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 4 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 4 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 2 | 2 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 1 | 2 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 2 | 1 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 1 | 2 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 4 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 3 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 4 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 5 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 5 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 1 | 2 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 1 | 1 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 1 | 3 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 5 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 2 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 2 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 5 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 3 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 5 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 5 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 1 | 1 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 3 | 1 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 4 | 1 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 2 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 2 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 5 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 3 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 3 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 5 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 4 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 1 | 1 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 2 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 3 | 0 Participants |
| RPH - 80 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 2 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 2 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 3 | 1 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 1 | 2 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 2 | 1 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 4 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 3 | 1 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 4 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 4 | 1 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 3 | 1 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 3 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 5 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 3 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 5 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 2 | 1 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 5 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 4 | 1 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 3 | 1 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 4 | 1 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 3 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 3 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 1 | 1 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 4 | 1 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 2 | 1 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 5 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 1 | 1 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 4 | 1 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 2 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 5 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 2 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 1 | 1 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 1 | 2 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 5 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 1 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 2 | 1 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 4 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 4 | 1 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 2 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 5 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 4 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 1 | 2 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 1 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 2 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 5 | 1 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 5 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 4 | 2 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 3 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 1 | 1 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 3 | 2 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 2 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 2 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 1 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 1 | 1 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 3 | 1 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 4 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 1 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 3 | 1 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 5 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 5 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 5 | 0 Participants |
| RPH - 160 mg | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 2 | 2 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 2 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 3 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 1 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 4 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 5 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 1 | 2 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 1 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 3 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 5 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 3 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 4 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 3 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 2 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 2 | 2 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 3 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 5 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 4 | 3 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 2 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 3 | 6 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 1 | 5 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 2 | 4 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 1 | 2 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 5 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Baseline | 2 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 5 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 5 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 2 | 4 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 4 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 3 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 3 | 2 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 5 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 2 | 1 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 3 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 2 | 4 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 15 | 4 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 1 | 1 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 3 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 18 | 4 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 5 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 4 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 22 | 5 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 4 | 1 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 1 | 4 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 2 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 2/ 24 hours | 3 | 3 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 29 | 5 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 4 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 2 | 1 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 1 | 4 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 6 | 1 | 5 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 4 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 45 | 4 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 2 | 5 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 10 | 1 | 3 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 3 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 4 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 1 | 2 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 4/ 72 hours | 5 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 3/ 48 hours | 5 | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Movement Restrictions in the Specified Timeframes After Initiation of Treatment | Day 5 | 1 | 3 Participants |
Secondary
Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug
Change in the rate of swelling of the assessed joint evaluated in 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug compared to baseline. The rates of swelling were specified in the evaluation form as: absence = no swelling, mild = palpable swelling, moderate = visible swelling, severe = bulging outside the joint (where severe represented the worst possible degree of swelling and absence was the best outcome).
Time frame: Baseline and 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug
Population: It should be noted that estimates following the use of the rescue medication or a prohibited analgesic were not included in the descriptive statistics, therefore, the number of patients with analyzable data in treatment groups decreased over time.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | mild | 1 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | severe | 0 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | moderate | 0 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | mild | 1 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | absence | 0 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | moderate | 0 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | mild | 0 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | severe | 0 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | absence | 1 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | severe | 0 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | absence | 1 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | absence | 1 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | mild | 0 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | severe | 0 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | severe | 0 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | moderate | 0 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | mild | 1 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | absence | 1 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | moderate | 0 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | moderate | 0 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | severe | 0 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | moderate | 0 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | mild | 1 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | severe | 0 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | mild | 1 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | absence | 1 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | severe | 0 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | moderate | 0 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | mild | 1 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | absence | 1 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | absence | 1 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | absence | 1 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | moderate | 0 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | mild | 0 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | severe | 1 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | mild | 0 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | severe | 0 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | moderate | 8 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | mild | 2 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | absence | 1 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | severe | 5 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | moderate | 0 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | absence | 1 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | mild | 1 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | absence | 0 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | moderate | 9 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | severe | 0 Participants |
| RPH - 4 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | moderate | 0 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | mild | 1 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | severe | 0 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | absence | 2 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | mild | 1 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | moderate | 0 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | severe | 0 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | absence | 3 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | moderate | 0 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | moderate | 3 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | severe | 3 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | absence | 0 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | severe | 0 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | severe | 0 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | absence | 4 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | mild | 0 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | moderate | 0 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | absence | 3 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | mild | 0 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | moderate | 0 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | severe | 0 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | absence | 0 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | mild | 0 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | mild | 2 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | moderate | 3 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | mild | 0 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | moderate | 0 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | severe | 0 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | absence | 1 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | mild | 3 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | moderate | 1 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | severe | 0 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | absence | 2 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | mild | 2 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | moderate | 1 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | severe | 0 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | absence | 2 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | mild | 1 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | moderate | 1 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | severe | 0 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | absence | 2 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | mild | 2 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | moderate | 0 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | severe | 0 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | absence | 3 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | mild | 0 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | moderate | 0 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | severe | 0 Participants |
| RPH - 20 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | absence | 4 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | severe | 3 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | mild | 1 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | moderate | 1 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | mild | 0 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | mild | 1 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | moderate | 2 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | severe | 0 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | absence | 0 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | severe | 3 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | mild | 0 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | moderate | 0 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | mild | 0 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | moderate | 0 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | mild | 0 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | moderate | 1 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | severe | 0 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | severe | 0 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | mild | 0 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | severe | 1 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | absence | 0 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | moderate | 0 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | severe | 0 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | mild | 0 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | severe | 0 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | mild | 0 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | moderate | 0 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | moderate | 2 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | mild | 0 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | mild | 0 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | severe | 0 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | severe | 4 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | severe | 2 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | moderate | 0 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | moderate | 0 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | moderate | 1 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | absence | 0 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | mild | 0 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | severe | 0 Participants |
| RPH - 40 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | moderate | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | absence | 3 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | absence | 1 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | severe | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | moderate | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | severe | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | absence | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | mild | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | absence | 2 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | moderate | 4 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | severe | 2 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | absence | 1 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | mild | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | mild | 1 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | moderate | 3 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | mild | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | absence | 1 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | severe | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | mild | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | absence | 3 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | mild | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | moderate | 1 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | severe | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | severe | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | moderate | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | absence | 3 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | moderate | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | moderate | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | moderate | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | severe | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | mild | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | mild | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | severe | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | moderate | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | severe | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | severe | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | absence | 2 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | mild | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | absence | 1 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | mild | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | absence | 1 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | moderate | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | mild | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | moderate | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | severe | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | absence | 1 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | mild | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | moderate | 0 Participants |
| RPH - 80 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | severe | 0 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | moderate | 0 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | moderate | 0 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | absence | 1 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | moderate | 0 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | absence | 1 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | mild | 1 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | mild | 1 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | severe | 0 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | moderate | 1 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | severe | 4 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | severe | 0 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | severe | 0 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | moderate | 0 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | absence | 1 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | mild | 1 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | moderate | 1 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | absence | 0 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | mild | 1 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | absence | 0 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | moderate | 1 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | absence | 0 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | mild | 0 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | mild | 0 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | severe | 0 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | mild | 1 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | absence | 1 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | absence | 2 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | severe | 0 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | severe | 0 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | mild | 2 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | severe | 0 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | moderate | 0 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | mild | 1 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | absence | 1 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | mild | 1 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | absence | 2 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | severe | 0 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | moderate | 0 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | moderate | 2 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | absence | 1 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | mild | 1 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | severe | 0 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | mild | 1 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | moderate | 0 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | moderate | 2 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | severe | 0 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | absence | 2 Participants |
| RPH - 160 mg | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | severe | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | mild | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | moderate | 3 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | absence | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | absence | 4 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | moderate | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | severe | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | moderate | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | mild | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | mild | 2 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | absence | 4 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | mild | 5 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | severe | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | mild | 3 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | absence | 2 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | moderate | 1 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | severe | 3 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | moderate | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | severe | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | moderate | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | severe | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | severe | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | mild | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | severe | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | mild | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | moderate | 5 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | moderate | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | absence | 4 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | severe | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | moderate | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | absence | 4 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | mild | 5 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | moderate | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | mild | 2 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | mild | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | absence | 4 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | mild | 1 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | absence | 4 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | severe | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | moderate | 1 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | absence | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | absence | 6 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | moderate | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | absence | 2 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | severe | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | severe | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | absence | 2 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | mild | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Swelling of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | severe | 0 Participants |
Secondary
Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug
Change in the rate of tenderness of the assessed joint evaluated in 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug compared to baseline. Tenderness degrees: absent = no tenderness, mild = tenderness when touched, moderate = pain and flinching, severe = pain, flinching and withdrawal of the limb (where severe represents the worst possible degree of tenderness and absent is the best outcome).
Time frame: Baseline and 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug
Population: It should be noted that estimates following the use of the rescue medication or a prohibited analgesic were not included in the descriptive statistics, therefore, the number of patients with analyzable data in treatment groups decreased over time.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | moderate | 0 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | moderate | 0 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | mild | 0 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | severe | 0 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | absence | 0 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | absence | 1 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | mild | 1 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | severe | 0 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | moderate | 0 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | severe | 2 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | mild | 1 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | absence | 1 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | absence | 1 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | mild | 4 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | moderate | 12 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | severe | 0 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | mild | 1 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | severe | 0 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | moderate | 0 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | moderate | 0 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | severe | 0 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | absence | 1 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | absence | 1 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | mild | 1 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | mild | 1 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | absence | 1 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | moderate | 0 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | absence | 0 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | severe | 1 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | severe | 0 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | absence | 1 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | moderate | 6 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | mild | 1 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | severe | 0 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | moderate | 0 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | severe | 0 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | moderate | 0 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | absence | 1 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | mild | 1 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | mild | 0 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | mild | 1 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | moderate | 0 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | absence | 0 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | severe | 0 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | severe | 0 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | absence | 1 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | mild | 0 Participants |
| RPH - 4 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | moderate | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | severe | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | mild | 2 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | severe | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | moderate | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | absence | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | moderate | 4 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | mild | 1 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | absence | 3 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | moderate | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | severe | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | absence | 3 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | absence | 2 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | moderate | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | absence | 3 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | severe | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | absence | 3 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | moderate | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | severe | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | severe | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | mild | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | mild | 1 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | mild | 1 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | severe | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | mild | 5 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | severe | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | moderate | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | mild | 1 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | moderate | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | moderate | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | severe | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | severe | 1 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | absence | 2 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | absence | 2 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | mild | 3 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | absence | 3 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | moderate | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | absence | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | absence | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | moderate | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | severe | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | mild | 2 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | moderate | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | mild | 5 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | mild | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | mild | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | moderate | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | severe | 0 Participants |
| RPH - 20 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | absence | 3 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | moderate | 1 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | mild | 0 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | moderate | 1 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | moderate | 0 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | mild | 0 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | mild | 2 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | severe | 1 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | mild | 0 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | absence | 0 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | severe | 2 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | moderate | 1 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | moderate | 0 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | severe | 0 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | moderate | 1 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | moderate | 0 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | severe | 0 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | severe | 0 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | mild | 0 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | absence | 0 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | mild | 0 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | moderate | 0 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | severe | 0 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | severe | 0 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | moderate | 3 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | moderate | 1 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | severe | 1 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | severe | 0 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | moderate | 0 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | mild | 0 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | mild | 1 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | mild | 0 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | moderate | 0 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | severe | 3 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | severe | 0 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | absence | 0 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | absence | 0 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | severe | 2 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | mild | 0 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | mild | 3 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | absence | 1 Participants |
| RPH - 40 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | mild | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | mild | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | severe | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | moderate | 1 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | severe | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | severe | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | absence | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | mild | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | moderate | 4 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | severe | 2 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | absence | 1 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | absence | 3 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | mild | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | moderate | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | absence | 2 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | moderate | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | absence | 2 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | mild | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | moderate | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | severe | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | absence | 1 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | mild | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | moderate | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | severe | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | absence | 1 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | mild | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | moderate | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | severe | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | absence | 1 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | mild | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | moderate | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | severe | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | absence | 1 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | mild | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | moderate | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | severe | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | absence | 1 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | mild | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | moderate | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | severe | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | mild | 1 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | moderate | 3 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | absence | 1 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | mild | 2 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | severe | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | absence | 2 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | mild | 1 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | moderate | 0 Participants |
| RPH - 80 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | severe | 0 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | mild | 2 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | mild | 1 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | absence | 2 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | moderate | 0 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | severe | 0 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | mild | 0 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | severe | 0 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | moderate | 0 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | mild | 1 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | absence | 0 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | absence | 2 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | absence | 0 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | mild | 1 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | severe | 0 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | moderate | 0 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | severe | 0 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | moderate | 0 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | mild | 1 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | moderate | 0 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | severe | 0 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | mild | 1 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | absence | 2 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | severe | 0 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | severe | 0 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | moderate | 1 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | moderate | 0 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | mild | 2 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | moderate | 0 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | absence | 1 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | absence | 1 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | mild | 2 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | moderate | 1 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | mild | 1 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | absence | 1 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | severe | 0 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | absence | 2 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | severe | 0 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | absence | 1 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | severe | 3 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | moderate | 0 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | mild | 1 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | moderate | 2 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | severe | 0 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | absence | 1 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | severe | 0 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | absence | 1 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | moderate | 0 Participants |
| RPH - 160 mg | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | mild | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | mild | 1 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | mild | 1 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | mild | 3 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | absence | 1 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | severe | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | mild | 4 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | mild | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | moderate | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | severe | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | absence | 4 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | moderate | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | absence | 3 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | severe | 3 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | severe | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | absence | 1 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | mild | 1 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 29 | absence | 3 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | absence | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | severe | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | absence | 4 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 15 | absence | 5 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | moderate | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | severe | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | severe | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | severe | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | mild | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | mild | 6 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | moderate | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | moderate | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | mild | 4 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | mild | 1 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | moderate | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | mild | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | moderate | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 10 | absence | 4 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 5 | absence | 3 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 18 | moderate | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 45 | severe | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | moderate | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | absence | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | mild | 6 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Baseline | moderate | 6 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | severe | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | 22 | absence | 1 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 3/ 48 hours | severe | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 4/ 72 hours | severe | 0 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 2/ 24 hours | moderate | 2 Participants |
| Voltaren® (Diclofenac) | Change in the Rate of Tenderness of the Assessed Joint Evaluated After the Initiation of Treatment With the Test Drug | Day 6 | moderate | 0 Participants |
Secondary
Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising
Changes in the Health Assessment Questionnaire (HAQ) parameters in 15, 29 and 45 days following the initiation of treatment with the test drug as compared to baseline. The result was calculated as the maximum score of responses (on an ordinal scale from 0 to 3) to questions included in this category. Patients were asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst). If the patient required outside help or any of the specified aids or devices to perform actions related to a certain category, then this category was assigned 2 points, if the point was not equal to 3, i.e. points 0 and 1 increased to 2.
Time frame: Baseline and 15, 29 and 45 days following the initiation of treatment with the test drug
Population: It should be noted that estimates following the use of the rescue medication or a prohibited analgesic were not included in the descriptive statistics.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RPH - 4 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising | Baseline value | 0.9 units of the HAQ index | Standard Deviation 0.74 |
| RPH - 4 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising | Change Day 15 | -1.0 units of the HAQ index | — |
| RPH - 4 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising | Change Day 29 | -1.0 units of the HAQ index | — |
| RPH - 4 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising | Change Day 45 | -1.0 units of the HAQ index | — |
| RPH - 20 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising | Change Day 29 | -1.3 units of the HAQ index | Standard Deviation 0.5 |
| RPH - 20 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising | Change Day 15 | -1.0 units of the HAQ index | Standard Deviation 0.82 |
| RPH - 20 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising | Baseline value | 1.3 units of the HAQ index | Standard Deviation 0.52 |
| RPH - 20 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising | Change Day 45 | -1.3 units of the HAQ index | Standard Deviation 0.58 |
| RPH - 40 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising | Change Day 45 | -1.0 units of the HAQ index | — |
| RPH - 40 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising | Change Day 29 | -1.0 units of the HAQ index | — |
| RPH - 40 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising | Change Day 15 | -1.0 units of the HAQ index | — |
| RPH - 40 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising | Baseline value | 1.5 units of the HAQ index | Standard Deviation 1.05 |
| RPH - 80 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising | Baseline value | 0.7 units of the HAQ index | Standard Deviation 0.82 |
| RPH - 80 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising | Change Day 45 | 0.0 units of the HAQ index | — |
| RPH - 80 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising | Change Day 15 | 0.0 units of the HAQ index | — |
| RPH - 80 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising | Change Day 29 | 0.0 units of the HAQ index | — |
| RPH - 160 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising | Change Day 29 | -0.5 units of the HAQ index | Standard Deviation 0.71 |
| RPH - 160 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising | Change Day 45 | -0.5 units of the HAQ index | Standard Deviation 0.71 |
| RPH - 160 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising | Change Day 15 | -1.0 units of the HAQ index | Standard Deviation 0 |
| RPH - 160 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising | Baseline value | 1.4 units of the HAQ index | Standard Deviation 0.55 |
| Voltaren® (Diclofenac) | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising | Change Day 15 | -0.5 units of the HAQ index | Standard Deviation 0.55 |
| Voltaren® (Diclofenac) | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising | Change Day 29 | 0.0 units of the HAQ index | Standard Deviation 0.82 |
| Voltaren® (Diclofenac) | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising | Change Day 45 | 0.0 units of the HAQ index | Standard Deviation 0 |
| Voltaren® (Diclofenac) | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Arising | Baseline value | 1.2 units of the HAQ index | Standard Deviation 0.97 |
Secondary
Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index
Changes in the Health Assessment Questionnaire (HAQ) parameters in 15, 29 and 45 days following the initiation of treatment with the test drug as compared to baseline. (The result for each of the 8 categories (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, Activities) of the HAQ questionnaire was calculated as the maximum score of responses (on an ordinal scale from 0 (best) to 3 (worst): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3)) to questions included in this category. If the patient required outside help or any of the specified aids or devices to perform actions related to a certain category, then this category was assigned 2 points, if the point was not equal to 3, i.e. points 0 and 1 increased to 2. The sum of points for the evaluated categories was calculated and divided by the number of categories, which gives a disability index in the range of 0 to 3.)
Time frame: Baseline and 15, 29 and 45 days following the initiation of treatment with the test drug
Population: It should be noted that estimates following the use of the rescue medication or a prohibited analgesic were not included in the descriptive statistics.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RPH - 4 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index | Baseline value | 1.3 units of the HAQ index | Standard Deviation 0.802 |
| RPH - 4 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index | Change Day 15 | -0.75 units of the HAQ index | — |
| RPH - 4 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index | Change Day 29 | -0.13 units of the HAQ index | — |
| RPH - 4 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index | Change Day 45 | -0.38 units of the HAQ index | — |
| RPH - 20 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index | Change Day 29 | -1.09 units of the HAQ index | Standard Deviation 0.672 |
| RPH - 20 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index | Change Day 15 | -0.63 units of the HAQ index | Standard Deviation 0.685 |
| RPH - 20 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index | Baseline value | 1.23 units of the HAQ index | Standard Deviation 0.578 |
| RPH - 20 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index | Change Day 45 | -1.42 units of the HAQ index | Standard Deviation 0.382 |
| RPH - 40 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index | Change Day 45 | -1.38 units of the HAQ index | — |
| RPH - 40 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index | Change Day 29 | -1.25 units of the HAQ index | — |
| RPH - 40 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index | Change Day 15 | -0.88 units of the HAQ index | — |
| RPH - 40 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index | Baseline value | 1.75 units of the HAQ index | Standard Deviation 0.806 |
| RPH - 80 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index | Baseline value | 1.1 units of the HAQ index | Standard Deviation 0.649 |
| RPH - 80 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index | Change Day 45 | -0.63 units of the HAQ index | — |
| RPH - 80 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index | Change Day 15 | -0.63 units of the HAQ index | — |
| RPH - 80 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index | Change Day 29 | -0.63 units of the HAQ index | — |
| RPH - 160 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index | Change Day 29 | -0.5 units of the HAQ index | Standard Deviation 0.53 |
| RPH - 160 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index | Change Day 45 | -0.56 units of the HAQ index | Standard Deviation 0.619 |
| RPH - 160 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index | Change Day 15 | -1.06 units of the HAQ index | Standard Deviation 0.619 |
| RPH - 160 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index | Baseline value | 1.6 units of the HAQ index | Standard Deviation 0.615 |
| Voltaren® (Diclofenac) | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index | Change Day 15 | -0.56 units of the HAQ index | Standard Deviation 0.342 |
| Voltaren® (Diclofenac) | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index | Change Day 29 | -0.38 units of the HAQ index | Standard Deviation 0.144 |
| Voltaren® (Diclofenac) | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index | Change Day 45 | -0.44 units of the HAQ index | Standard Deviation 0.298 |
| Voltaren® (Diclofenac) | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Disability Index | Baseline value | 1.32 units of the HAQ index | Standard Deviation 0.577 |
Secondary
Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating
Changes in the Health Assessment Questionnaire (HAQ) parameters in 15, 29 and 45 days following the initiation of treatment with the test drug as compared to baseline. The result was calculated as the maximum score of responses (on an ordinal scale from 0 to 3) to questions included in this category. Patients were asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst). If the patient required outside help or any of the specified aids or devices to perform actions related to a certain category, then this category was assigned 2 points, if the point was not equal to 3, i.e. points 0 and 1 increased to 2.
Time frame: Baseline and 15, 29 and 45 days following the initiation of treatment with the test drug
Population: It should be noted that estimates following the use of the rescue medication or a prohibited analgesic were not included in the descriptive statistics.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RPH - 4 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating | Baseline value | 1.0 units of the HAQ index | Standard Deviation 1.2 |
| RPH - 4 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating | Change Day 15 | 0.0 units of the HAQ index | — |
| RPH - 4 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating | Change Day 29 | 0.0 units of the HAQ index | — |
| RPH - 4 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating | Change Day 45 | 0.0 units of the HAQ index | — |
| RPH - 20 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating | Change Day 29 | -1.0 units of the HAQ index | Standard Deviation 0.82 |
| RPH - 20 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating | Change Day 15 | -0.5 units of the HAQ index | Standard Deviation 1 |
| RPH - 20 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating | Baseline value | 0.7 units of the HAQ index | Standard Deviation 0.82 |
| RPH - 20 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating | Change Day 45 | -1.3 units of the HAQ index | Standard Deviation 0.58 |
| RPH - 40 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating | Change Day 45 | 0.0 units of the HAQ index | — |
| RPH - 40 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating | Change Day 29 | 0.0 units of the HAQ index | — |
| RPH - 40 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating | Change Day 15 | 0.0 units of the HAQ index | — |
| RPH - 40 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating | Baseline value | 1.3 units of the HAQ index | Standard Deviation 1.37 |
| RPH - 80 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating | Baseline value | 0.8 units of the HAQ index | Standard Deviation 1.17 |
| RPH - 80 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating | Change Day 45 | 0.0 units of the HAQ index | — |
| RPH - 80 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating | Change Day 15 | 0.0 units of the HAQ index | — |
| RPH - 80 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating | Change Day 29 | 0.0 units of the HAQ index | — |
| RPH - 160 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating | Change Day 29 | -0.5 units of the HAQ index | Standard Deviation 0.71 |
| RPH - 160 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating | Change Day 45 | -0.5 units of the HAQ index | Standard Deviation 0.71 |
| RPH - 160 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating | Change Day 15 | 0.0 units of the HAQ index | Standard Deviation 0 |
| RPH - 160 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating | Baseline value | 1.0 units of the HAQ index | Standard Deviation 1 |
| Voltaren® (Diclofenac) | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating | Change Day 15 | -0.3 units of the HAQ index | Standard Deviation 0.52 |
| Voltaren® (Diclofenac) | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating | Change Day 29 | -0.3 units of the HAQ index | Standard Deviation 0.5 |
| Voltaren® (Diclofenac) | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating | Change Day 45 | -0.3 units of the HAQ index | Standard Deviation 0.5 |
| Voltaren® (Diclofenac) | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Eating | Baseline value | 0.7 units of the HAQ index | Standard Deviation 1 |
Secondary
Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip
Changes in the Health Assessment Questionnaire (HAQ) parameters in 15, 29 and 45 days following the initiation of treatment with the test drug as compared to baseline. The result was calculated as the maximum score of responses (on an ordinal scale from 0 to 3) to questions included in this category. Patients were asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst). If the patient required outside help or any of the specified aids or devices to perform actions related to a certain category, then this category was assigned 2 points, if the point was not equal to 3, i.e. points 0 and 1 increased to 2.
Time frame: Baseline and 15, 29 and 45 days following the initiation of treatment with the test drug
Population: It should be noted that estimates following the use of the rescue medication or a prohibited analgesic were not included in the descriptive statistics.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RPH - 4 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip | Baseline value | 1.4 units of the HAQ index | Standard Deviation 0.99 |
| RPH - 4 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip | Change Day 15 | -1.0 units of the HAQ index | — |
| RPH - 4 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip | Change Day 29 | -1.0 units of the HAQ index | — |
| RPH - 4 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip | Change Day 45 | -1.0 units of the HAQ index | — |
| RPH - 20 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip | Change Day 29 | -1.0 units of the HAQ index | Standard Deviation 0.82 |
| RPH - 20 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip | Change Day 15 | -0.5 units of the HAQ index | Standard Deviation 0.58 |
| RPH - 20 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip | Baseline value | 1.0 units of the HAQ index | Standard Deviation 0.63 |
| RPH - 20 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip | Change Day 45 | -1.3 units of the HAQ index | Standard Deviation 0.58 |
| RPH - 40 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip | Change Day 45 | 0.0 units of the HAQ index | — |
| RPH - 40 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip | Change Day 29 | 0.0 units of the HAQ index | — |
| RPH - 40 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip | Change Day 15 | 0.0 units of the HAQ index | — |
| RPH - 40 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip | Baseline value | 1.2 units of the HAQ index | Standard Deviation 1.17 |
| RPH - 80 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip | Baseline value | 1.0 units of the HAQ index | Standard Deviation 1.1 |
| RPH - 80 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip | Change Day 45 | -1.0 units of the HAQ index | — |
| RPH - 80 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip | Change Day 15 | -1.0 units of the HAQ index | — |
| RPH - 80 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip | Change Day 29 | -1.0 units of the HAQ index | — |
| RPH - 160 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip | Change Day 29 | -0.5 units of the HAQ index | Standard Deviation 0.71 |
| RPH - 160 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip | Change Day 45 | -1.0 units of the HAQ index | Standard Deviation 1.41 |
| RPH - 160 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip | Change Day 15 | 0.0 units of the HAQ index | Standard Deviation 0 |
| RPH - 160 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip | Baseline value | 1.2 units of the HAQ index | Standard Deviation 1.1 |
| Voltaren® (Diclofenac) | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip | Change Day 15 | -0.2 units of the HAQ index | Standard Deviation 0.41 |
| Voltaren® (Diclofenac) | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip | Change Day 29 | -0.3 units of the HAQ index | Standard Deviation 0.5 |
| Voltaren® (Diclofenac) | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip | Change Day 45 | 0.3 units of the HAQ index | Standard Deviation 1.26 |
| Voltaren® (Diclofenac) | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Grip | Baseline value | 0.4 units of the HAQ index | Standard Deviation 0.73 |
Secondary
Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene
Changes in the Health Assessment Questionnaire (HAQ) parameters in 15, 29 and 45 days following the initiation of treatment with the test drug as compared to baseline. The result was calculated as the maximum score of responses (on an ordinal scale from 0 to 3) to questions included in this category. Patients were asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst). If the patient required outside help or any of the specified aids or devices to perform actions related to a certain category, then this category was assigned 2 points, if the point was not equal to 3, i.e. points 0 and 1 increased to 2.
Time frame: Baseline and 15, 29 and 45 days following the initiation of treatment with the test drug
Population: It should be noted that estimates following the use of the rescue medication or a prohibited analgesic were not included in the descriptive statistics.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RPH - 4 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene | Baseline value | 1.2 units of the HAQ index | Standard Deviation 1.21 |
| RPH - 4 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene | Change Day 15 | -1.0 units of the HAQ index | — |
| RPH - 4 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene | Change Day 29 | 1.0 units of the HAQ index | — |
| RPH - 4 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene | Change Day 45 | 0.0 units of the HAQ index | — |
| RPH - 20 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene | Change Day 29 | -1.3 units of the HAQ index | Standard Deviation 0.96 |
| RPH - 20 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene | Change Day 15 | -0.3 units of the HAQ index | Standard Deviation 1.26 |
| RPH - 20 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene | Baseline value | 1.2 units of the HAQ index | Standard Deviation 0.98 |
| RPH - 20 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene | Change Day 45 | -1.7 units of the HAQ index | Standard Deviation 0.58 |
| RPH - 40 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene | Change Day 45 | -1.0 units of the HAQ index | — |
| RPH - 40 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene | Change Day 29 | -1.0 units of the HAQ index | — |
| RPH - 40 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene | Change Day 15 | -1.0 units of the HAQ index | — |
| RPH - 40 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene | Baseline value | 1.7 units of the HAQ index | Standard Deviation 1.03 |
| RPH - 80 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene | Baseline value | 1.5 units of the HAQ index | Standard Deviation 1.05 |
| RPH - 80 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene | Change Day 45 | -1.0 units of the HAQ index | — |
| RPH - 80 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene | Change Day 15 | -1.0 units of the HAQ index | — |
| RPH - 80 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene | Change Day 29 | -1.0 units of the HAQ index | — |
| RPH - 160 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene | Change Day 29 | -0.5 units of the HAQ index | Standard Deviation 0.71 |
| RPH - 160 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene | Change Day 45 | -0.5 units of the HAQ index | Standard Deviation 0.71 |
| RPH - 160 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene | Change Day 15 | -2.5 units of the HAQ index | Standard Deviation 0.71 |
| RPH - 160 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene | Baseline value | 2.2 units of the HAQ index | Standard Deviation 0.45 |
| Voltaren® (Diclofenac) | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene | Change Day 15 | -0.5 units of the HAQ index | Standard Deviation 0.55 |
| Voltaren® (Diclofenac) | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene | Change Day 29 | -0.5 units of the HAQ index | Standard Deviation 0.58 |
| Voltaren® (Diclofenac) | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene | Change Day 45 | -1.0 units of the HAQ index | Standard Deviation 0.82 |
| Voltaren® (Diclofenac) | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Hygiene | Baseline value | 1.3 units of the HAQ index | Standard Deviation 0.5 |
Secondary
Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking
Changes in the Health Assessment Questionnaire (HAQ) parameters in 15, 29 and 45 days following the initiation of treatment with the test drug as compared to baseline. The result was calculated as the maximum score of responses (on an ordinal scale from 0 to 3) to questions included in this category. Patients were asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst). If the patient required outside help or any of the specified aids or devices to perform actions related to a certain category, then this category was assigned 2 points, if the point was not equal to 3, i.e. points 0 and 1 increased to 2.
Time frame: Baseline and 15, 29 and 45 days following the initiation of treatment with the test drug
Population: It should be noted that estimates following the use of the rescue medication or a prohibited analgesic were not included in the descriptive statistics.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RPH - 4 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking | Baseline value | 1.4 units of the HAQ index | Standard Deviation 0.74 |
| RPH - 4 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking | Change Day 15 | 0.0 units of the HAQ index | — |
| RPH - 4 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking | Change Day 29 | 0.0 units of the HAQ index | — |
| RPH - 4 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking | Change Day 45 | 0.0 units of the HAQ index | — |
| RPH - 20 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking | Change Day 29 | -1.3 units of the HAQ index | Standard Deviation 0.96 |
| RPH - 20 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking | Change Day 15 | -1.3 units of the HAQ index | Standard Deviation 0.96 |
| RPH - 20 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking | Baseline value | 1.8 units of the HAQ index | Standard Deviation 0.75 |
| RPH - 20 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking | Change Day 45 | -1.3 units of the HAQ index | Standard Deviation 1.15 |
| RPH - 40 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking | Change Day 45 | -2.0 units of the HAQ index | — |
| RPH - 40 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking | Change Day 29 | -2.0 units of the HAQ index | — |
| RPH - 40 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking | Change Day 15 | -1.0 units of the HAQ index | — |
| RPH - 40 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking | Baseline value | 1.8 units of the HAQ index | Standard Deviation 1.17 |
| RPH - 80 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking | Baseline value | 1.3 units of the HAQ index | Standard Deviation 0.82 |
| RPH - 80 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking | Change Day 45 | -1.0 units of the HAQ index | — |
| RPH - 80 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking | Change Day 15 | -1.0 units of the HAQ index | — |
| RPH - 80 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking | Change Day 29 | -1.0 units of the HAQ index | — |
| RPH - 160 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking | Change Day 29 | -0.5 units of the HAQ index | Standard Deviation 0.71 |
| RPH - 160 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking | Change Day 45 | -0.5 units of the HAQ index | Standard Deviation 0.71 |
| RPH - 160 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking | Change Day 15 | -1.5 units of the HAQ index | Standard Deviation 0.71 |
| RPH - 160 mg | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking | Baseline value | 1.6 units of the HAQ index | Standard Deviation 1.14 |
| Voltaren® (Diclofenac) | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking | Change Day 15 | -0.7 units of the HAQ index | Standard Deviation 0.82 |
| Voltaren® (Diclofenac) | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking | Change Day 29 | -0.3 units of the HAQ index | Standard Deviation 0.5 |
| Voltaren® (Diclofenac) | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking | Change Day 45 | -0.8 units of the HAQ index | Standard Deviation 0.96 |
| Voltaren® (Diclofenac) | Changes in the Health Assessment Questionnaire (HAQ) Parameters: Walking | Baseline value | 1.8 units of the HAQ index | Standard Deviation 0.67 |
Secondary
Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good
Proportion of patients who assessed the response to therapy with the test drug as Excellent or Good in 15, 30, 45 minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 following the initiation of treatment with the test drug. The patient's response to therapy was assessed in the form of frequency tables by assessment point and therapy group. The rates of the response were specified in the evaluation form as: Excellent, Good, Fair, Weak, Poor (where excellent represents the best possible response to treatment and poor indicates the worst treatment response).
Time frame: 15, 30, 45 minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 after the initiation of treatment with the test drug
Population: The table shows the frequencies and proportions (%) of the number of valid observations. Values after the use of rescue medication and after withdrawal were imputed as failure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RPH - 4 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 22 | 0 Participants |
| RPH - 4 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 6 | 1 Participants |
| RPH - 4 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 4 hours | 2 Participants |
| RPH - 4 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 18 | 1 Participants |
| RPH - 4 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 15 | 1 Participants |
| RPH - 4 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 10 | 1 Participants |
| RPH - 4 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 1.5 hours | 3 Participants |
| RPH - 4 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 1 hour | 3 Participants |
| RPH - 4 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/45 minutes | 3 Participants |
| RPH - 4 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 2 | 1 Participants |
| RPH - 4 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 8 hours | 2 Participants |
| RPH - 4 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/30 minutes | 2 Participants |
| RPH - 4 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 3 | 1 Participants |
| RPH - 4 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 2 hours | 3 Participants |
| RPH - 4 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/15 minutes | 0 Participants |
| RPH - 4 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 4 | 1 Participants |
| RPH - 4 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 45 | 0 Participants |
| RPH - 4 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 29 | 1 Participants |
| RPH - 4 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 5 | 1 Participants |
| RPH - 20 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 29 | 2 Participants |
| RPH - 20 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/30 minutes | 1 Participants |
| RPH - 20 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 45 | 1 Participants |
| RPH - 20 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 4 hours | 0 Participants |
| RPH - 20 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 15 | 2 Participants |
| RPH - 20 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 3 | 1 Participants |
| RPH - 20 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 22 | 2 Participants |
| RPH - 20 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 10 | 1 Participants |
| RPH - 20 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 1.5 hours | 0 Participants |
| RPH - 20 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/15 minutes | 1 Participants |
| RPH - 20 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 1 hour | 0 Participants |
| RPH - 20 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 8 hours | 1 Participants |
| RPH - 20 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 6 | 2 Participants |
| RPH - 20 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 18 | 1 Participants |
| RPH - 20 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/45 minutes | 1 Participants |
| RPH - 20 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 5 | 1 Participants |
| RPH - 20 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 4 | 1 Participants |
| RPH - 20 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 2 | 0 Participants |
| RPH - 20 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 2 hours | 0 Participants |
| RPH - 40 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/30 minutes | 0 Participants |
| RPH - 40 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 4 hours | 2 Participants |
| RPH - 40 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 8 hours | 2 Participants |
| RPH - 40 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 2 | 2 Participants |
| RPH - 40 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 3 | 2 Participants |
| RPH - 40 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 4 | 1 Participants |
| RPH - 40 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 5 | 1 Participants |
| RPH - 40 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 6 | 1 Participants |
| RPH - 40 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 10 | 1 Participants |
| RPH - 40 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 15 | 1 Participants |
| RPH - 40 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 18 | 1 Participants |
| RPH - 40 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 22 | 1 Participants |
| RPH - 40 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 29 | 1 Participants |
| RPH - 40 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 45 | 1 Participants |
| RPH - 40 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/15 minutes | 0 Participants |
| RPH - 40 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/45 minutes | 0 Participants |
| RPH - 40 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 1 hour | 0 Participants |
| RPH - 40 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 1.5 hours | 1 Participants |
| RPH - 40 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 2 hours | 1 Participants |
| RPH - 80 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 8 hours | 1 Participants |
| RPH - 80 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/45 minutes | 2 Participants |
| RPH - 80 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 3 | 1 Participants |
| RPH - 80 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 18 | 1 Participants |
| RPH - 80 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/15 minutes | 1 Participants |
| RPH - 80 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 15 | 1 Participants |
| RPH - 80 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 2 hours | 1 Participants |
| RPH - 80 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/30 minutes | 1 Participants |
| RPH - 80 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 1.5 hours | 1 Participants |
| RPH - 80 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 2 | 1 Participants |
| RPH - 80 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 4 hours | 1 Participants |
| RPH - 80 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 29 | 1 Participants |
| RPH - 80 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 5 | 3 Participants |
| RPH - 80 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 1 hour | 2 Participants |
| RPH - 80 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 6 | 2 Participants |
| RPH - 80 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 4 | 3 Participants |
| RPH - 80 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 10 | 2 Participants |
| RPH - 80 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 45 | 1 Participants |
| RPH - 80 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 22 | 1 Participants |
| RPH - 160 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 1.5 hours | 0 Participants |
| RPH - 160 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 18 | 2 Participants |
| RPH - 160 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 5 | 2 Participants |
| RPH - 160 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 22 | 2 Participants |
| RPH - 160 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 29 | 1 Participants |
| RPH - 160 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 4 | 2 Participants |
| RPH - 160 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 45 | 1 Participants |
| RPH - 160 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 3 | 2 Participants |
| RPH - 160 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/15 minutes | 0 Participants |
| RPH - 160 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 2 | 2 Participants |
| RPH - 160 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/30 minutes | 0 Participants |
| RPH - 160 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 8 hours | 2 Participants |
| RPH - 160 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/45 minutes | 0 Participants |
| RPH - 160 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 2 hours | 0 Participants |
| RPH - 160 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 1 hour | 0 Participants |
| RPH - 160 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 4 hours | 1 Participants |
| RPH - 160 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 10 | 2 Participants |
| RPH - 160 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 6 | 2 Participants |
| RPH - 160 mg | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 15 | 2 Participants |
| Voltaren® (Diclofenac) | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 45 | 3 Participants |
| Voltaren® (Diclofenac) | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 4 hours | 2 Participants |
| Voltaren® (Diclofenac) | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 22 | 5 Participants |
| Voltaren® (Diclofenac) | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 29 | 3 Participants |
| Voltaren® (Diclofenac) | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 18 | 4 Participants |
| Voltaren® (Diclofenac) | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 1 hour | 1 Participants |
| Voltaren® (Diclofenac) | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 15 | 6 Participants |
| Voltaren® (Diclofenac) | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 10 | 6 Participants |
| Voltaren® (Diclofenac) | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 2 hours | 1 Participants |
| Voltaren® (Diclofenac) | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 1.5 hours | 1 Participants |
| Voltaren® (Diclofenac) | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 2 | 2 Participants |
| Voltaren® (Diclofenac) | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 6 | 6 Participants |
| Voltaren® (Diclofenac) | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/30 minutes | 2 Participants |
| Voltaren® (Diclofenac) | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/ 8 hours | 4 Participants |
| Voltaren® (Diclofenac) | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 5 | 6 Participants |
| Voltaren® (Diclofenac) | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/15 minutes | 1 Participants |
| Voltaren® (Diclofenac) | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 3 | 5 Participants |
| Voltaren® (Diclofenac) | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 4 | 6 Participants |
| Voltaren® (Diclofenac) | Proportion of Patients Who Assessed the Response to Therapy With the Test Drug as Excellent or Good | Day 1/45 minutes | 2 Participants |
Secondary
Proportion of Patients Who Received a Rescue Therapy Agent
The proportion of patients who received the rescue medication over the entire treatment period
Time frame: up to day 60
Population: Patient 01003 was excluded from the analysis of the endpoint due to the use of prohibited therapy (methylprednisolone 125 mg, IV, daily from the 2nd day of therapy until the end of the study).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RPH - 4 mg | Proportion of Patients Who Received a Rescue Therapy Agent | 13 Participants |
| RPH - 20 mg | Proportion of Patients Who Received a Rescue Therapy Agent | 1 Participants |
| RPH - 40 mg | Proportion of Patients Who Received a Rescue Therapy Agent | 4 Participants |
| RPH - 80 mg | Proportion of Patients Who Received a Rescue Therapy Agent | 4 Participants |
| RPH - 160 mg | Proportion of Patients Who Received a Rescue Therapy Agent | 2 Participants |
| Voltaren® (Diclofenac) | Proportion of Patients Who Received a Rescue Therapy Agent | 3 Participants |
Secondary
Proportion of Patients Who Received a Rescue Therapy Agent
The proportion of patients who received the rescue medication within 72 hours of starting the investigational product therapy
Time frame: 72 hours after the initiation of treatment with the test drug
Population: Patient 01003 was excluded from the analysis of the endpoint due to the use of prohibited therapy (methylprednisolone 125 mg, IV, daily from the 2nd day of therapy until the end of the study).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RPH - 4 mg | Proportion of Patients Who Received a Rescue Therapy Agent | 12 Participants |
| RPH - 20 mg | Proportion of Patients Who Received a Rescue Therapy Agent | 1 Participants |
| RPH - 40 mg | Proportion of Patients Who Received a Rescue Therapy Agent | 3 Participants |
| RPH - 80 mg | Proportion of Patients Who Received a Rescue Therapy Agent | 3 Participants |
| RPH - 160 mg | Proportion of Patients Who Received a Rescue Therapy Agent | 2 Participants |
| Voltaren® (Diclofenac) | Proportion of Patients Who Received a Rescue Therapy Agent | 2 Participants |
p-value: 0.006695% CI: [19.9, 88.6]Fisher Exact
p-value: >0.999995% CI: [-50.1, 45.5]Fisher Exact
p-value: 0.328795% CI: [-26.8, 71.8]Fisher Exact
p-value: 0.328795% CI: [-26.8, 71.8]Fisher Exact
p-value: 0.580495% CI: [-33.7, 67.8]Fisher Exact
Secondary
Time to Achieve the 50% Decrease in Pain Intensity in the Assessed Joint Relative to the Baseline
Time to achieve the 50% decrease in pain intensity in the assessed joint relative to the baseline VAS level. VAS is a hard copy 100 mm scale with the indications: Absence of pain on the left side of the scale (0 mm point) and The most severe pain ever experienced on the right side of the scale (100 mm point)). The better outcome would be Absence of pain, the worse outcome would be The most severe pain ever experienced.
Time frame: Baseline and one of the pain intensity measurements in accordance with the schedule: 15, 30, 45 minutes, 1, 1.5, 2, 4, 8, 24, 48, 72 hours, on Days 5, 6, 10, 15, 18, 22, 29 and 45 after the initiation of treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RPH - 4 mg | Time to Achieve the 50% Decrease in Pain Intensity in the Assessed Joint Relative to the Baseline | NA hours |
| RPH - 20 mg | Time to Achieve the 50% Decrease in Pain Intensity in the Assessed Joint Relative to the Baseline | 6.0 hours |
| RPH - 40 mg | Time to Achieve the 50% Decrease in Pain Intensity in the Assessed Joint Relative to the Baseline | NA hours |
| RPH - 80 mg | Time to Achieve the 50% Decrease in Pain Intensity in the Assessed Joint Relative to the Baseline | NA hours |
| RPH - 160 mg | Time to Achieve the 50% Decrease in Pain Intensity in the Assessed Joint Relative to the Baseline | 8.0 hours |
| Voltaren® (Diclofenac) | Time to Achieve the 50% Decrease in Pain Intensity in the Assessed Joint Relative to the Baseline | 47.3 hours |
p-value: 0.5995Log Rank
p-value: 0.9012Log Rank
Secondary
Time to Use of the Rescue Medication
Time to use of the rescue medication was calculated as the time in hours from the date/time of administration (first dose) of the investigational product to the date/time of the first use of the rescue medication.
Time frame: from the date/time of IP administration (first dose) to the date/time of the first use of the rescue medication, up to day 60
Population: Patient 01003 was excluded from the analysis of the endpoint due to the use of prohibited therapy (methylprednisolone 125 mg, IV, daily from the 2nd day of therapy until the end of the study).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RPH - 4 mg | Time to Use of the Rescue Medication | 23.7 hours |
| RPH - 20 mg | Time to Use of the Rescue Medication | NA hours |
| RPH - 40 mg | Time to Use of the Rescue Medication | 71.8 hours |
| RPH - 80 mg | Time to Use of the Rescue Medication | 84.6 hours |
| RPH - 160 mg | Time to Use of the Rescue Medication | NA hours |
| Voltaren® (Diclofenac) | Time to Use of the Rescue Medication | NA hours |
Other Pre-specified
Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes
Change in the rate of serum amyloid protein A in 24, 72 hours and on Day 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline
Time frame: Baseline and in 24, 72 hours and on Day 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug
Population: Number of valid observations is presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RPH - 4 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 2/ 24 hours | 17424.060 ng/mL | Standard Deviation 17167.2073 |
| RPH - 4 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 6 | 18553.955 ng/mL | Standard Deviation 15454.2373 |
| RPH - 4 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 15 | 9272.782 ng/mL | Standard Deviation 11297.9676 |
| RPH - 4 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 45 | 13858.845 ng/mL | Standard Deviation 16512.5575 |
| RPH - 4 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 4/ 72 hours | 17588.735 ng/mL | Standard Deviation 16623.4301 |
| RPH - 4 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 29 | 8918.439 ng/mL | Standard Deviation 12001.1492 |
| RPH - 4 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 5 | 17360.201 ng/mL | Standard Deviation 15874.5237 |
| RPH - 4 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Baseline value | 13493.687 ng/mL | Standard Deviation 14565.0449 |
| RPH - 20 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 2/ 24 hours | 11078.300 ng/mL | Standard Deviation 19281.3822 |
| RPH - 20 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 29 | 4255.756 ng/mL | Standard Deviation 6845.1947 |
| RPH - 20 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Baseline value | 2516.606 ng/mL | Standard Deviation 1367.7981 |
| RPH - 20 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 5 | 1195.975 ng/mL | Standard Deviation 393.6981 |
| RPH - 20 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 4/ 72 hours | 1171.203 ng/mL | Standard Deviation 400.3851 |
| RPH - 20 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 45 | 2086.198 ng/mL | Standard Deviation 2799.5039 |
| RPH - 20 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 6 | 1847.923 ng/mL | Standard Deviation 1646.0125 |
| RPH - 20 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 15 | 1525.612 ng/mL | Standard Deviation 502.8845 |
| RPH - 40 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 6 | 4781.173 ng/mL | Standard Deviation 6120.5728 |
| RPH - 40 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 2/ 24 hours | 20104.555 ng/mL | Standard Deviation 15608.376 |
| RPH - 40 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 45 | 1269.680 ng/mL | Standard Deviation 695.3511 |
| RPH - 40 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 5 | 5680.190 ng/mL | Standard Deviation 5708.9022 |
| RPH - 40 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Baseline value | 16764.020 ng/mL | Standard Deviation 14525.1072 |
| RPH - 40 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 29 | 1645.107 ng/mL | Standard Deviation 1044.8811 |
| RPH - 40 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 15 | 8899.982 ng/mL | Standard Deviation 17399.0042 |
| RPH - 40 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 4/ 72 hours | 12162.612 ng/mL | Standard Deviation 12060.2753 |
| RPH - 80 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 29 | 3626.702 ng/mL | Standard Deviation 2740.1283 |
| RPH - 80 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 45 | 1567.040 ng/mL | Standard Deviation 1421.4541 |
| RPH - 80 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 2/ 24 hours | 15581.486 ng/mL | Standard Deviation 13271.7115 |
| RPH - 80 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 4/ 72 hours | 14419.760 ng/mL | Standard Deviation 11828.2546 |
| RPH - 80 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 5 | 8228.272 ng/mL | Standard Deviation 7624.1329 |
| RPH - 80 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Baseline value | 16168.130 ng/mL | Standard Deviation 12937.7377 |
| RPH - 80 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 6 | 5799.608 ng/mL | Standard Deviation 5562.998 |
| RPH - 80 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 15 | 4582.338 ng/mL | Standard Deviation 5995.5993 |
| RPH - 160 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 6 | 6117.777 ng/mL | Standard Deviation 8569.9756 |
| RPH - 160 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 29 | 3618.843 ng/mL | Standard Deviation 3147.2319 |
| RPH - 160 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 15 | 2732.598 ng/mL | Standard Deviation 1325.3698 |
| RPH - 160 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 5 | 5952.460 ng/mL | Standard Deviation 10455.6856 |
| RPH - 160 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 4/ 72 hours | 10596.423 ng/mL | Standard Deviation 16813.3253 |
| RPH - 160 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 2/ 24 hours | 3659.778 ng/mL | Standard Deviation 3244.2099 |
| RPH - 160 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 45 | 9885.230 ng/mL | Standard Deviation 15228.9607 |
| RPH - 160 mg | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Baseline value | 16291.605 ng/mL | Standard Deviation 17949.6741 |
| Voltaren® (Diclofenac) | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 45 | 7289.553 ng/mL | Standard Deviation 7189.8429 |
| Voltaren® (Diclofenac) | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Baseline value | 5033.151 ng/mL | Standard Deviation 3384.3761 |
| Voltaren® (Diclofenac) | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 2/ 24 hours | 7294.631 ng/mL | Standard Deviation 5163.5001 |
| Voltaren® (Diclofenac) | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 4/ 72 hours | 7362.322 ng/mL | Standard Deviation 9834.7459 |
| Voltaren® (Diclofenac) | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 5 | 8252.633 ng/mL | Standard Deviation 8121.6203 |
| Voltaren® (Diclofenac) | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 6 | 6165.779 ng/mL | Standard Deviation 5356.4841 |
| Voltaren® (Diclofenac) | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 15 | 6031.146 ng/mL | Standard Deviation 10261.9489 |
| Voltaren® (Diclofenac) | Change in the Rate of Serum Amyloid Protein A in the Specified Timeframes | Day 29 | 3779.410 ng/mL | Standard Deviation 2727.95 |
Other Pre-specified
Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes
Change in the serum rate of high-sensitive CRP (hs-CRP) in 24, 72 hours, on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug compared to baseline
Time frame: Baseline and in 24, 72 hours, on Days 5, 6, 15, 29 and 45 after the initiation of treatment with the test drug
Population: Number of valid observations is presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RPH - 4 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 4/ 72 hours | 33.894 mg/L | Standard Deviation 35.0873 |
| RPH - 4 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 2/ 24 hours | 35.468 mg/L | Standard Deviation 32.2025 |
| RPH - 4 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Baseline value | 36.673 mg/L | Standard Deviation 31.3545 |
| RPH - 4 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 5 | 32.279 mg/L | Standard Deviation 32.6858 |
| RPH - 4 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 6 | 29.065 mg/L | Standard Deviation 28.1288 |
| RPH - 4 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 15 | 21.017 mg/L | Standard Deviation 28.4384 |
| RPH - 4 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 29 | 16.811 mg/L | Standard Deviation 26.3922 |
| RPH - 4 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 45 | 24.958 mg/L | Standard Deviation 29.445 |
| RPH - 20 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 5 | 3.090 mg/L | Standard Deviation 0.9076 |
| RPH - 20 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 45 | 3.570 mg/L | Standard Deviation 2.1907 |
| RPH - 20 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Baseline value | 8.295 mg/L | Standard Deviation 6.6212 |
| RPH - 20 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 29 | 7.532 mg/L | Standard Deviation 13.0615 |
| RPH - 20 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 15 | 2.642 mg/L | Standard Deviation 1.4322 |
| RPH - 20 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 4/ 72 hours | 3.408 mg/L | Standard Deviation 0.812 |
| RPH - 20 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 2/ 24 hours | 20.338 mg/L | Standard Deviation 33.3728 |
| RPH - 20 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 6 | 2.710 mg/L | Standard Deviation 1.614 |
| RPH - 40 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 2/ 24 hours | 24.483 mg/L | Standard Deviation 16.3543 |
| RPH - 40 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 4/ 72 hours | 12.900 mg/L | Standard Deviation 9.3579 |
| RPH - 40 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 5 | 7.142 mg/L | Standard Deviation 5.7071 |
| RPH - 40 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 45 | 2.445 mg/L | Standard Deviation 1.8315 |
| RPH - 40 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 6 | 3.650 mg/L | Standard Deviation 2.8445 |
| RPH - 40 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 15 | 3.304 mg/L | Standard Deviation 5.8018 |
| RPH - 40 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 29 | 2.750 mg/L | Standard Deviation 2.9068 |
| RPH - 40 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Baseline value | 10.105 mg/L | Standard Deviation 14.2834 |
| RPH - 80 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 29 | 5.014 mg/L | Standard Deviation 2.848 |
| RPH - 80 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 15 | 5.115 mg/L | Standard Deviation 3.5382 |
| RPH - 80 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 6 | 4.604 mg/L | Standard Deviation 1.3871 |
| RPH - 80 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Baseline value | 37.908 mg/L | Standard Deviation 25.5594 |
| RPH - 80 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 4/ 72 hours | 11.846 mg/L | Standard Deviation 6.178 |
| RPH - 80 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 5 | 8.696 mg/L | Standard Deviation 3.6468 |
| RPH - 80 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 45 | 3.093 mg/L | Standard Deviation 0.5652 |
| RPH - 80 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 2/ 24 hours | 28.864 mg/L | Standard Deviation 16.1194 |
| RPH - 160 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 45 | 14.500 mg/L | Standard Deviation 19.2882 |
| RPH - 160 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Baseline value | 35.396 mg/L | Standard Deviation 32.48 |
| RPH - 160 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 6 | 3.190 mg/L | Standard Deviation 3.0165 |
| RPH - 160 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 15 | 4.042 mg/L | Standard Deviation 6.1199 |
| RPH - 160 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 29 | 10.998 mg/L | Standard Deviation 17.3463 |
| RPH - 160 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 2/ 24 hours | 12.000 mg/L | Standard Deviation 11.5518 |
| RPH - 160 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 4/ 72 hours | 8.678 mg/L | Standard Deviation 10.5037 |
| RPH - 160 mg | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 5 | 6.178 mg/L | Standard Deviation 6.4262 |
| Voltaren® (Diclofenac) | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 45 | 11.734 mg/L | Standard Deviation 11.4627 |
| Voltaren® (Diclofenac) | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 6 | 8.417 mg/L | Standard Deviation 7.044 |
| Voltaren® (Diclofenac) | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 4/ 72 hours | 9.279 mg/L | Standard Deviation 8.1642 |
| Voltaren® (Diclofenac) | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 5 | 8.877 mg/L | Standard Deviation 6.3308 |
| Voltaren® (Diclofenac) | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 15 | 6.579 mg/L | Standard Deviation 4.4134 |
| Voltaren® (Diclofenac) | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 2/ 24 hours | 22.716 mg/L | Standard Deviation 26.9958 |
| Voltaren® (Diclofenac) | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Day 29 | 7.595 mg/L | Standard Deviation 7.987 |
| Voltaren® (Diclofenac) | Change in the Serum Rate of High-sensitive CRP (Hs-CRP) in Specified Timeframes | Baseline value | 15.769 mg/L | Standard Deviation 18.0878 |
Other Pre-specified
Change in the Serum Rates of Cytokines: IL-1α
Change in the serum rates of IL-1α in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline
Time frame: Baseline and in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug
Population: Number of valid observations is presented. (IL-1a values \<1.10 were replaced with 1.09 for graphical representation and statistical analysis.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 4/ 72 hours | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 2/ 24 hours | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-1α | Baseline value | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 5 | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 6 | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 15 | 1.132 pg/mL | Standard Deviation 0.1525 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 29 | 1.097 pg/mL | Standard Deviation 0.0258 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 45 | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 5 | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 45 | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-1α | Baseline value | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 29 | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 15 | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 4/ 72 hours | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 2/ 24 hours | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 6 | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 2/ 24 hours | 1.097 pg/mL | Standard Deviation 0.0163 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 4/ 72 hours | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 5 | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 45 | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 6 | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 15 | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 29 | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-1α | Baseline value | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 29 | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 15 | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 6 | 1.612 pg/mL | Standard Deviation 1.1672 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-1α | Baseline value | 1.752 pg/mL | Standard Deviation 1.539 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 4/ 72 hours | 1.688 pg/mL | Standard Deviation 1.3372 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 5 | 1.790 pg/mL | Standard Deviation 1.5652 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 45 | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 2/ 24 hours | 1.782 pg/mL | Standard Deviation 1.5474 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 45 | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-1α | Baseline value | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 6 | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 15 | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 29 | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 2/ 24 hours | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 4/ 72 hours | 1.090 pg/mL | Standard Deviation 0 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-1α | Day 5 | 1.090 pg/mL | Standard Deviation 0 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-1α | Day 45 | 1.090 pg/mL | Standard Deviation 0 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-1α | Day 6 | 1.090 pg/mL | Standard Deviation 0 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-1α | Day 4/ 72 hours | 1.090 pg/mL | Standard Deviation 0 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-1α | Day 5 | 1.090 pg/mL | Standard Deviation 0 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-1α | Day 15 | 1.090 pg/mL | Standard Deviation 0 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-1α | Day 2/ 24 hours | 1.090 pg/mL | Standard Deviation 0 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-1α | Day 29 | 1.090 pg/mL | Standard Deviation 0 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-1α | Baseline value | 1.090 pg/mL | Standard Deviation 0 |
Other Pre-specified
Change in the Serum Rates of Cytokines: IL-1β
Change in the serum rates of IL-1β in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline
Time frame: Baseline and in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug
Population: Number of valid observations is presented. (IL-1β \<0.30 values were replaced with 0.29, IL-1β \> 500.00 values were replaced with 500.01 for graphical presentation and statistical analysis.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-1β | Baseline value | 39.035 pg/mL | Standard Deviation 138.5078 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 2/ 24 hours | 33.885 pg/mL | Standard Deviation 128.9519 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 4/ 72 hours | 33.759 pg/mL | Standard Deviation 128.9859 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 5 | 33.753 pg/mL | Standard Deviation 128.9873 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 6 | 33.998 pg/mL | Standard Deviation 128.9231 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 15 | 38.730 pg/mL | Standard Deviation 138.5974 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 29 | 33.811 pg/mL | Standard Deviation 128.9724 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 45 | 0.290 pg/mL | Standard Deviation 0 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-1β | Baseline value | 1.080 pg/mL | Standard Deviation 1.9351 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 15 | 1.222 pg/mL | Standard Deviation 2.084 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 45 | 0.290 pg/mL | Standard Deviation 0 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 5 | 0.290 pg/mL | Standard Deviation 0 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 4/ 72 hours | 0.290 pg/mL | Standard Deviation 0 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 29 | 1.320 pg/mL | Standard Deviation 2.3032 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 2/ 24 hours | 0.290 pg/mL | Standard Deviation 0 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 6 | 0.290 pg/mL | Standard Deviation 0 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 5 | 0.290 pg/mL | Standard Deviation 0 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 29 | 0.417 pg/mL | Standard Deviation 0.3103 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 4/ 72 hours | 0.290 pg/mL | Standard Deviation 0 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-1β | Baseline value | 0.290 pg/mL | Standard Deviation 0 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 15 | 0.290 pg/mL | Standard Deviation 0 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 2/ 24 hours | 0.290 pg/mL | Standard Deviation 0 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 45 | 0.290 pg/mL | Standard Deviation 0 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 6 | 0.290 pg/mL | Standard Deviation 0 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 45 | 0.290 pg/mL | Standard Deviation 0 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 4/ 72 hours | 2.112 pg/mL | Standard Deviation 4.0741 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 15 | 1.965 pg/mL | Standard Deviation 3.35 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 6 | 2.362 pg/mL | Standard Deviation 4.6331 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-1β | Baseline value | 2.558 pg/mL | Standard Deviation 3.5248 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 5 | 0.290 pg/mL | Standard Deviation 0 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 29 | 1.746 pg/mL | Standard Deviation 3.2557 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 2/ 24 hours | 1.100 pg/mL | Standard Deviation 1.8112 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 6 | 0.290 pg/mL | Standard Deviation 0 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 2/ 24 hours | 0.290 pg/mL | Standard Deviation 0 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 4/ 72 hours | 0.290 pg/mL | Standard Deviation 0 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 5 | 0.290 pg/mL | Standard Deviation 0 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 15 | 0.290 pg/mL | Standard Deviation 0 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 45 | 0.290 pg/mL | Standard Deviation 0 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-1β | Day 29 | 0.290 pg/mL | Standard Deviation 0 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-1β | Baseline value | 0.290 pg/mL | Standard Deviation 0 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-1β | Day 29 | 0.290 pg/mL | Standard Deviation 0 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-1β | Day 5 | 0.290 pg/mL | Standard Deviation 0 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-1β | Day 4/ 72 hours | 0.290 pg/mL | Standard Deviation 0 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-1β | Day 2/ 24 hours | 0.290 pg/mL | Standard Deviation 0 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-1β | Day 45 | 0.290 pg/mL | Standard Deviation 0 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-1β | Baseline value | 0.290 pg/mL | Standard Deviation 0 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-1β | Day 15 | 0.290 pg/mL | Standard Deviation 0 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-1β | Day 6 | 0.290 pg/mL | Standard Deviation 0 |
Other Pre-specified
Change in the Serum Rates of Cytokines: IL-6
Change in the serum rates of IL-6 in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline
Time frame: Baseline and in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug
Population: Number of valid observations is presented. (IL-6 values \<0.92 were replaced with 0.913, IL-6 values \>200.00 were replaced with 200.01 for graphical representation and statistical analysis.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 4/ 72 hours | 14.943 pg/mL | Standard Deviation 29.9008 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 2/ 24 hours | 27.030 pg/mL | Standard Deviation 42.9908 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-6 | Baseline value | 26.035 pg/mL | Standard Deviation 39.1257 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 5 | 23.999 pg/mL | Standard Deviation 37.5678 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 6 | 8.391 pg/mL | Standard Deviation 13.3742 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 15 | 10.595 pg/mL | Standard Deviation 14.4444 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 29 | 18.643 pg/mL | Standard Deviation 50.4658 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 45 | 6.466 pg/mL | Standard Deviation 9.1261 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 5 | 2.695 pg/mL | Standard Deviation 2.2949 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 45 | 4.608 pg/mL | Standard Deviation 5.8999 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-6 | Baseline value | 5.005 pg/mL | Standard Deviation 4.6022 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 29 | 2.758 pg/mL | Standard Deviation 1.7315 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 15 | 2.870 pg/mL | Standard Deviation 1.5838 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 4/ 72 hours | 2.236 pg/mL | Standard Deviation 1.8533 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 2/ 24 hours | 2.084 pg/mL | Standard Deviation 1.893 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 6 | 3.565 pg/mL | Standard Deviation 3.5282 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 2/ 24 hours | 37.788 pg/mL | Standard Deviation 72.3187 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 4/ 72 hours | 2.145 pg/mL | Standard Deviation 0.9961 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 5 | 2.378 pg/mL | Standard Deviation 1.9432 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 45 | 3.370 pg/mL | Standard Deviation 4.5051 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 6 | 2.965 pg/mL | Standard Deviation 3.4991 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 15 | 2.434 pg/mL | Standard Deviation 1.7929 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 29 | 3.278 pg/mL | Standard Deviation 4.2245 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-6 | Baseline value | 34.307 pg/mL | Standard Deviation 54.3264 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 29 | 1.482 pg/mL | Standard Deviation 0.5334 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 15 | 1.793 pg/mL | Standard Deviation 0.5907 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 6 | 1.272 pg/mL | Standard Deviation 0.3636 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-6 | Baseline value | 5.623 pg/mL | Standard Deviation 6.8564 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 4/ 72 hours | 3.142 pg/mL | Standard Deviation 3.729 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 5 | 1.396 pg/mL | Standard Deviation 0.5031 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 45 | 1.537 pg/mL | Standard Deviation 0.3911 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 2/ 24 hours | 6.284 pg/mL | Standard Deviation 11.1153 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 45 | 3.753 pg/mL | Standard Deviation 1.6094 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-6 | Baseline value | 13.666 pg/mL | Standard Deviation 11.9695 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 6 | 6.220 pg/mL | Standard Deviation 9.8491 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 15 | 12.858 pg/mL | Standard Deviation 25.3149 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 29 | 17.903 pg/mL | Standard Deviation 31.1335 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 2/ 24 hours | 9.065 pg/mL | Standard Deviation 12.5843 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 4/ 72 hours | 4.698 pg/mL | Standard Deviation 7.3223 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-6 | Day 5 | 4.905 pg/mL | Standard Deviation 7.5114 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-6 | Day 45 | 2.607 pg/mL | Standard Deviation 1.9663 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-6 | Day 6 | 2.157 pg/mL | Standard Deviation 2.125 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-6 | Day 4/ 72 hours | 1.702 pg/mL | Standard Deviation 1.1067 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-6 | Day 5 | 1.823 pg/mL | Standard Deviation 1.6473 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-6 | Day 15 | 2.036 pg/mL | Standard Deviation 1.2089 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-6 | Day 2/ 24 hours | 2.361 pg/mL | Standard Deviation 1.2039 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-6 | Day 29 | 5.304 pg/mL | Standard Deviation 7.4387 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-6 | Baseline value | 6.058 pg/mL | Standard Deviation 6.9686 |
Other Pre-specified
Change in the Serum Rates of Cytokines: IL-8
Change in the serum rates of IL-8 in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline
Time frame: Baseline and in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug
Population: Number of valid observations is presented. (IL-8 values \<2.00 were replaced with 1.99 for graphical representation and statistical analysis.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 4/ 72 hours | 15.601 pg/mL | Standard Deviation 19.4714 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 2/ 24 hours | 8.228 pg/mL | Standard Deviation 7.1217 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-8 | Baseline value | 12.384 pg/mL | Standard Deviation 5.8297 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 5 | 13.521 pg/mL | Standard Deviation 7.8988 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 6 | 16.969 pg/mL | Standard Deviation 16.9723 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 15 | 9.765 pg/mL | Standard Deviation 9.3536 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 29 | 19.766 pg/mL | Standard Deviation 20.8879 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 45 | 12.664 pg/mL | Standard Deviation 7.2467 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 5 | 4.313 pg/mL | Standard Deviation 2.6941 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 45 | 5.468 pg/mL | Standard Deviation 4.112 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-8 | Baseline value | 21.964 pg/mL | Standard Deviation 24.8759 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 29 | 25.622 pg/mL | Standard Deviation 36.4743 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 15 | 20.884 pg/mL | Standard Deviation 31.6507 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 4/ 72 hours | 8.708 pg/mL | Standard Deviation 5.8951 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 2/ 24 hours | 9.304 pg/mL | Standard Deviation 9.7609 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 6 | 8.015 pg/mL | Standard Deviation 4.6897 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 2/ 24 hours | 9.030 pg/mL | Standard Deviation 5.5014 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 4/ 72 hours | 9.020 pg/mL | Standard Deviation 6.203 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 5 | 8.032 pg/mL | Standard Deviation 4.9402 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 45 | 5.807 pg/mL | Standard Deviation 5.8272 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 6 | 7.937 pg/mL | Standard Deviation 5.3199 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 15 | 11.520 pg/mL | Standard Deviation 7.4313 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 29 | 8.003 pg/mL | Standard Deviation 6.1368 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: IL-8 | Baseline value | 9.277 pg/mL | Standard Deviation 4.5347 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 29 | 8.596 pg/mL | Standard Deviation 9.2114 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 15 | 16.395 pg/mL | Standard Deviation 19.5556 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 6 | 7.594 pg/mL | Standard Deviation 5.9449 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-8 | Baseline value | 18.305 pg/mL | Standard Deviation 21.8921 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 4/ 72 hours | 5.952 pg/mL | Standard Deviation 4.4991 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 5 | 10.518 pg/mL | Standard Deviation 6.8098 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 45 | 7.223 pg/mL | Standard Deviation 3.0891 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 2/ 24 hours | 12.304 pg/mL | Standard Deviation 9.9136 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 45 | 7.927 pg/mL | Standard Deviation 5.3051 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-8 | Baseline value | 12.318 pg/mL | Standard Deviation 12.5702 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 6 | 10.745 pg/mL | Standard Deviation 6.301 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 15 | 3.060 pg/mL | Standard Deviation 2.3926 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 29 | 9.243 pg/mL | Standard Deviation 5.1441 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 2/ 24 hours | 2.668 pg/mL | Standard Deviation 1.355 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 4/ 72 hours | 8.148 pg/mL | Standard Deviation 5.6025 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: IL-8 | Day 5 | 11.190 pg/mL | Standard Deviation 4.4376 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-8 | Day 45 | 11.763 pg/mL | Standard Deviation 11.1239 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-8 | Day 6 | 19.881 pg/mL | Standard Deviation 21.0673 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-8 | Day 4/ 72 hours | 15.980 pg/mL | Standard Deviation 11.735 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-8 | Day 5 | 15.188 pg/mL | Standard Deviation 12.3696 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-8 | Day 15 | 34.770 pg/mL | Standard Deviation 66.4033 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-8 | Day 2/ 24 hours | 17.141 pg/mL | Standard Deviation 13.6494 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-8 | Day 29 | 8.554 pg/mL | Standard Deviation 7.6207 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: IL-8 | Baseline value | 10.863 pg/mL | Standard Deviation 7.1505 |
Other Pre-specified
Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA)
Change in the serum rates of IL-1RA in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline
Time frame: Baseline and in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug
Population: Number of valid observations is presented. (IL-1RA values \<30.00 were replaced with 29.99 for graphical representation and statistical analysis.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RPH - 4 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 4/ 72 hours | 1295.743 pg/mL | Standard Deviation 916.8659 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 2/ 24 hours | 1700.180 pg/mL | Standard Deviation 1448.4981 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Baseline value | 2400.500 pg/mL | Standard Deviation 1495.11 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 5 | 1364.993 pg/mL | Standard Deviation 1106.8245 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 6 | 1407.230 pg/mL | Standard Deviation 927.8243 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 15 | 1620.332 pg/mL | Standard Deviation 935.4363 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 29 | 1928.417 pg/mL | Standard Deviation 1048.0875 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 45 | 1806.647 pg/mL | Standard Deviation 858.8185 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 5 | 187.223 pg/mL | Standard Deviation 109.9846 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 45 | 915.010 pg/mL | Standard Deviation 177.2813 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Baseline value | 1448.978 pg/mL | Standard Deviation 527.8658 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 29 | 563.892 pg/mL | Standard Deviation 142.6097 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 15 | 374.900 pg/mL | Standard Deviation 96.9459 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 4/ 72 hours | 156.216 pg/mL | Standard Deviation 110.6281 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 2/ 24 hours | 229.842 pg/mL | Standard Deviation 291.9887 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 6 | 214.610 pg/mL | Standard Deviation 125.9518 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 2/ 24 hours | 153.098 pg/mL | Standard Deviation 145.378 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 4/ 72 hours | 140.108 pg/mL | Standard Deviation 123.8956 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 5 | 154.463 pg/mL | Standard Deviation 124.669 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 45 | 808.212 pg/mL | Standard Deviation 354.6509 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 6 | 203.688 pg/mL | Standard Deviation 133.0562 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 15 | 474.542 pg/mL | Standard Deviation 214.588 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 29 | 583.062 pg/mL | Standard Deviation 269.1237 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Baseline value | 1671.010 pg/mL | Standard Deviation 1225.2673 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 29 | 686.992 pg/mL | Standard Deviation 305.947 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 15 | 645.085 pg/mL | Standard Deviation 300.6542 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 6 | 180.492 pg/mL | Standard Deviation 112.2664 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Baseline value | 2240.155 pg/mL | Standard Deviation 937.1988 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 4/ 72 hours | 157.654 pg/mL | Standard Deviation 227.2334 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 5 | 87.214 pg/mL | Standard Deviation 79.7269 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 45 | 711.997 pg/mL | Standard Deviation 285.9941 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 2/ 24 hours | 29.990 pg/mL | Standard Deviation 0 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 45 | 518.063 pg/mL | Standard Deviation 201.1455 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Baseline value | 2619.456 pg/mL | Standard Deviation 2706.3397 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 6 | 29.990 pg/mL | Standard Deviation 0 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 15 | 257.492 pg/mL | Standard Deviation 166.0738 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 29 | 471.178 pg/mL | Standard Deviation 267.8262 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 2/ 24 hours | 29.990 pg/mL | Standard Deviation 0 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 4/ 72 hours | 29.990 pg/mL | Standard Deviation 0 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 5 | 29.990 pg/mL | Standard Deviation 0 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 45 | 1969.547 pg/mL | Standard Deviation 1352.6193 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 6 | 2426.761 pg/mL | Standard Deviation 1452.6687 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 4/ 72 hours | 2297.651 pg/mL | Standard Deviation 1361.7429 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 5 | 2417.991 pg/mL | Standard Deviation 1416.8428 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 15 | 2249.794 pg/mL | Standard Deviation 1459.3243 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 2/ 24 hours | 2483.891 pg/mL | Standard Deviation 1786.0361 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Day 29 | 1870.815 pg/mL | Standard Deviation 1032.8765 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: Interleukin -1 Receptor Antagonist (IL-1RA) | Baseline value | 2090.721 pg/mL | Standard Deviation 1240.5717 |
Other Pre-specified
Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α)
Change in the serum rates of TNF-α in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug as compared to baseline
Time frame: Baseline and in 24, 72 hours and on Days 5, 6, 15, 29 and 45 following the initiation of treatment with the test drug
Population: Number of valid observations is presented. (TNF-α values \<2.30 were replaced with 2.29 for graphical representation and statistical analysis.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RPH - 4 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 4/ 72 hours | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 2/ 24 hours | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Baseline value | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 5 | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 6 | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 15 | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 29 | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 4 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 45 | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 5 | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 45 | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Baseline value | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 29 | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 15 | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 4/ 72 hours | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 2/ 24 hours | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 20 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 6 | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 2/ 24 hours | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 4/ 72 hours | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 5 | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 45 | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 6 | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 15 | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 29 | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 40 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Baseline value | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 29 | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 15 | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 6 | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Baseline value | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 4/ 72 hours | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 5 | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 45 | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 80 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 2/ 24 hours | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 45 | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Baseline value | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 6 | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 15 | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 29 | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 2/ 24 hours | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 4/ 72 hours | 2.290 pg/mL | Standard Deviation 0 |
| RPH - 160 mg | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 5 | 2.290 pg/mL | Standard Deviation 0 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 45 | 2.290 pg/mL | Standard Deviation 0 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 6 | 2.290 pg/mL | Standard Deviation 0 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 4/ 72 hours | 2.290 pg/mL | Standard Deviation 0 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 5 | 2.290 pg/mL | Standard Deviation 0 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 15 | 2.290 pg/mL | Standard Deviation 0 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 2/ 24 hours | 2.290 pg/mL | Standard Deviation 0 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Day 29 | 2.290 pg/mL | Standard Deviation 0 |
| Voltaren® (Diclofenac) | Change in the Serum Rates of Cytokines: Tumor Necrosis Factor (TNF-α) | Baseline value | 2.290 pg/mL | Standard Deviation 0 |
Other Pre-specified
Pharmacokinetics (PK) - Area Under the Active Substance Concentration- of RPH-104 Under the Subcutaneous Administration
Including Area under the active substance concentration-time curve from zero (before drug administration) to infinity (AUC0-∞)
Time frame: Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| RPH - 4 mg | Pharmacokinetics (PK) - Area Under the Active Substance Concentration- of RPH-104 Under the Subcutaneous Administration | 47900 h*ng/mL | Geometric Coefficient of Variation 97.9 |
| RPH - 20 mg | Pharmacokinetics (PK) - Area Under the Active Substance Concentration- of RPH-104 Under the Subcutaneous Administration | 816000 h*ng/mL | Geometric Coefficient of Variation 155 |
| RPH - 40 mg | Pharmacokinetics (PK) - Area Under the Active Substance Concentration- of RPH-104 Under the Subcutaneous Administration | 901000 h*ng/mL | Geometric Coefficient of Variation 44.3 |
| RPH - 80 mg | Pharmacokinetics (PK) - Area Under the Active Substance Concentration- of RPH-104 Under the Subcutaneous Administration | 1720000 h*ng/mL | Geometric Coefficient of Variation 37.1 |
| RPH - 160 mg | Pharmacokinetics (PK) - Area Under the Active Substance Concentration- of RPH-104 Under the Subcutaneous Administration | 3380000 h*ng/mL | Geometric Coefficient of Variation 38.1 |
Other Pre-specified
Pharmacokinetics (PK) - Area Under the Plasma concentration-of RPH-104 Under the Subcutaneous Administration
Including area under the plasma concentration-time curve over the dosing interval (AUC0-tau)
Time frame: Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| RPH - 4 mg | Pharmacokinetics (PK) - Area Under the Plasma concentration-of RPH-104 Under the Subcutaneous Administration | 38000 h*ng/mL | Geometric Coefficient of Variation 124 |
| RPH - 20 mg | Pharmacokinetics (PK) - Area Under the Plasma concentration-of RPH-104 Under the Subcutaneous Administration | 762000 h*ng/mL | Geometric Coefficient of Variation 152 |
| RPH - 40 mg | Pharmacokinetics (PK) - Area Under the Plasma concentration-of RPH-104 Under the Subcutaneous Administration | 845000 h*ng/mL | Geometric Coefficient of Variation 45 |
| RPH - 80 mg | Pharmacokinetics (PK) - Area Under the Plasma concentration-of RPH-104 Under the Subcutaneous Administration | 1620000 h*ng/mL | Geometric Coefficient of Variation 36.5 |
| RPH - 160 mg | Pharmacokinetics (PK) - Area Under the Plasma concentration-of RPH-104 Under the Subcutaneous Administration | 3230000 h*ng/mL | Geometric Coefficient of Variation 38.2 |
Other Pre-specified
Pharmacokinetics (PK) - Maximum Concentration of the Active Substance -of RPH-104 Under the Subcutaneous Administration
Including Maximum concentration of the active substance (Cmax)
Time frame: Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| RPH - 4 mg | Pharmacokinetics (PK) - Maximum Concentration of the Active Substance -of RPH-104 Under the Subcutaneous Administration | 142 ng/mL | Geometric Coefficient of Variation 110 |
| RPH - 20 mg | Pharmacokinetics (PK) - Maximum Concentration of the Active Substance -of RPH-104 Under the Subcutaneous Administration | 2220 ng/mL | Geometric Coefficient of Variation 155 |
| RPH - 40 mg | Pharmacokinetics (PK) - Maximum Concentration of the Active Substance -of RPH-104 Under the Subcutaneous Administration | 2380 ng/mL | Geometric Coefficient of Variation 47.7 |
| RPH - 80 mg | Pharmacokinetics (PK) - Maximum Concentration of the Active Substance -of RPH-104 Under the Subcutaneous Administration | 4860 ng/mL | Geometric Coefficient of Variation 18 |
| RPH - 160 mg | Pharmacokinetics (PK) - Maximum Concentration of the Active Substance -of RPH-104 Under the Subcutaneous Administration | 9760 ng/mL | Geometric Coefficient of Variation 38.2 |
Other Pre-specified
Pharmacokinetics (PK) of RPH-104 Under the Subcutaneous Administration
Including elimination constant (Kel)
Time frame: Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RPH - 4 mg | Pharmacokinetics (PK) of RPH-104 Under the Subcutaneous Administration | 0.00298 1/h | Standard Deviation 0.000573 |
| RPH - 20 mg | Pharmacokinetics (PK) of RPH-104 Under the Subcutaneous Administration | 0.00314 1/h | Standard Deviation 0.000622 |
| RPH - 40 mg | Pharmacokinetics (PK) of RPH-104 Under the Subcutaneous Administration | 0.00304 1/h | Standard Deviation 0.000241 |
| RPH - 80 mg | Pharmacokinetics (PK) of RPH-104 Under the Subcutaneous Administration | 0.00317 1/h | Standard Deviation 0.000575 |
| RPH - 160 mg | Pharmacokinetics (PK) of RPH-104 Under the Subcutaneous Administration | 0.00294 1/h | Standard Deviation 0.000311 |
Other Pre-specified
Pharmacokinetics (PK) - Terminal Half-life -of RPH-104 Under the Subcutaneous Administration
Including terminal half-life (T 1/2)
Time frame: Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RPH - 4 mg | Pharmacokinetics (PK) - Terminal Half-life -of RPH-104 Under the Subcutaneous Administration | 248 hours |
| RPH - 20 mg | Pharmacokinetics (PK) - Terminal Half-life -of RPH-104 Under the Subcutaneous Administration | 235 hours |
| RPH - 40 mg | Pharmacokinetics (PK) - Terminal Half-life -of RPH-104 Under the Subcutaneous Administration | 223 hours |
| RPH - 80 mg | Pharmacokinetics (PK) - Terminal Half-life -of RPH-104 Under the Subcutaneous Administration | 231 hours |
| RPH - 160 mg | Pharmacokinetics (PK) - Terminal Half-life -of RPH-104 Under the Subcutaneous Administration | 241 hours |
Other Pre-specified
Pharmacokinetics (PK) -Time to Reach Maximum Concentration of the Active Substance - of RPH-104 Under the Subcutaneous Administration
Including Time to reach maximum concentration of the active substance (tmax)
Time frame: Baseline and in 2,8,24,48,72 hours,on Days 5,6,10,15,18,22,29,45 following the initiation of treatment with the test drug and on the follow-up visit (in case of premature withdrawal of patient)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RPH - 4 mg | Pharmacokinetics (PK) -Time to Reach Maximum Concentration of the Active Substance - of RPH-104 Under the Subcutaneous Administration | 93.7 hours |
| RPH - 20 mg | Pharmacokinetics (PK) -Time to Reach Maximum Concentration of the Active Substance - of RPH-104 Under the Subcutaneous Administration | 47.5 hours |
| RPH - 40 mg | Pharmacokinetics (PK) -Time to Reach Maximum Concentration of the Active Substance - of RPH-104 Under the Subcutaneous Administration | 84.8 hours |
| RPH - 80 mg | Pharmacokinetics (PK) -Time to Reach Maximum Concentration of the Active Substance - of RPH-104 Under the Subcutaneous Administration | 82.7 hours |
| RPH - 160 mg | Pharmacokinetics (PK) -Time to Reach Maximum Concentration of the Active Substance - of RPH-104 Under the Subcutaneous Administration | 94.4 hours |