Osteoarthritis
Conditions
Keywords
WOMAC, Knee osteoarthritis pain, Pain intensity, Tramadol, Acetaminophen, Meloxicam, Aceclofenac
Brief summary
The purpose of this study is to compare the effectiveness of tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg maintenance with that of non-steroidal anti-inflammatory drugs (NSAIDs) maintenance in participants with knee osteoarthritis (a progressive and degenerative joint disease, in which the joints become painful and stiff) whose pain was relieved after the add-on treatment of tramadol hydrochloride to NSAIDs.
Detailed description
This is a multicenter (when more than one hospital or medical school team work on a medical research study), randomized (the study drug is assigned by chance), open-label (all people know the identity of the intervention), comparative study to compare the efficacy of tramadol hydrochloride plus acetaminophen maintenance with that of NSAIDs maintenance in participants whose pain was relieved after the add-on treatment of tramadol 37.5 milligram (mg) plus acetaminophen 325 mg to NSAIDs. All participants will receive tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with NSAIDs (meloxicam \[7.5 mg or 15 mg once daily\] or aceclofenac \[100 mg twice daily\]) from Day 1 to Day 28, and participants will be randomly assigned into 2 treatment groups at Day 29 if the numerical rating scale score less than or equal 4. Tramadol plus acetaminophen group will receive 1 or 2 tablets containing tramadol 37.5 mg plus acetaminophen 325 mg 4 times daily (maximum daily dose will be 8 tablets) from Day 29 to Day 85 and NSAIDs group will receive either meloxicam 7.5 mg or 15 mg per day or aceclofenac 100 mg twice a day from Day 29 to Day 85. The efficacy will be evaluated on Day 1, Day 29, Day 57 and Day 85. The primary efficacy end point will be assessed through change in Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) total score from Day 29 to Day 85. Participant's safety will be monitored throughout the study.
Interventions
DRUGMeloxicam
Meloxicam 7.5 mg or 15 mg per day along with fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day from Day 1 to Day 28, and meloxicam 7.5 mg or 15 mg per day from Day 29 to Day 85.
DRUGAceclofenac
Aceclofenac 100 mg twice a day along with fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day from Day 1 to Day 28, and aceclofenac 100 mg twice a day from Day 29 to Day 85.
DRUGTramadol Hydrochloride Plus Acetaminophen
Fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with NSAIDs (meloxicam \[7.5 mg or 15 mg once daily\] or aceclofenac \[100 mg twice daily\]) from Day 1 to Day 28, and fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose will be 8 tablets).
Sponsors
Janssen Korea, Ltd., Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Participants who have suffered from knee osteoarthritis at least for one year and meet the criteria of American College of Rheumatology * Participants who are taking stable dose of meloxicam 7.5 milligram (mg) or 15 mg daily or aceclofenac 100 mg twice a day at least for four weeks * Participants whose mean pain intensity has been 5 or higher on the numeric rating scale (NRS) for the last 48 hours * Participants whose general health conditions are favorable, according to the criteria below: Medical and medication history, Physical examination before the study medication administration, Vital signs: Blood pressure, pulse, Clinical laboratory tests: Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvate transaminase (SGPT) less-than or equal to (=\<) 2 X normal range, Renal function: Creatinine less than (\<) 2.0 milligrams per deciliter (mg/dl) * Female participants of childbearing potential to use the proper contraceptive methods during the study period (Urine pregnancy test prior to the study participation should be negative)
Exclusion criteria
* Participants who are applicable to Kellgren and Lawrence grade * Participants who had failed tramadol treatment before or stopped taking tramadol due to adverse event(s) * Participants who are applicable to one of the following conditions: Rheumatoid arthritis, Ankylosing spondylitis, Active gout or active pseudo-gout, Diagnosis of fibromyalgia (according to ACR Criteria), Anserine bursitis, Major trauma of the target joint within six months prior to the study medication administration, Infection of the target joint within six months prior to the study medication administration, Apparent avascular necrosis of the target joint within six months prior to the study medication administration, Anatomical deformities of the target joint, which may interfere with assessment of the target joint, Surgical procedures associated with the target joint within one year prior to the study medication administration, Arthroscopic procedures associated with the target joint within six months prior to the study medication administration * Participants who have one of the following diseases: Significantly unstable diseases such as sleep disorder (e.g., sleep apnea or narcolepsy) or dementia, Functional damage or disease which may cause malabsorption, excessive accumulation, or metabolism or excretion disorder * Participants who are pregnant or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Day 29 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score at Day 85 | Day 29 and Day 85 | The WOMAC is a self-administered and health status questionnaire designed to capture elements of pain, stiffness and physical impairment in participants with osteoarthritis. It consists of 24 questions (5 questions about pain, 2 about stiffness and 17 about physical function) scored on a visual analog scale (VAS) of 0 to 10 cm (0 cm=no pain to 10 cm=worse pain). Individual question responses are assigned a score between 0=extreme and 4=none. Maximum scores for each element differ and therefore, scores were normalized. Total normalized score ranges from 0=worst to 100=best. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Pain Relief | Day 29, Day 57 and Day 85 | Pain relief was assessed by using a 6-point scale ranging from -1 to 4 where, -1=pain aggravated, 0=no change, 1=slightly relieved, 2=moderately relieved, 3=considerably relieved, and 4=pain completely disappeared. Participants with pain slightly relieved, moderately relieved and completely disappeared were considered as pain relieved. |
| Number of Participants With Overall Assessment on Study Drug by Participants | Day 85 | Participants' overall assessment on study drug was done by using a 5-point scale ranging from -2 to 2 where, -2= very bad, 1= bad, 0=moderate, 1=good and 2=very good. Study drug refers specifically to the randomized treatment received from Day 29 to Day 85. |
| Change From Day 29 in Pain Intensity Score at Day 85 | Day 29 and Day 85 | Pain intensity was evaluated by 11- point numeric rating scale ranging from 0 to 10 where, 0=no pain and 10=pain as bad as you can imagine. |
| Number of Participants With Categorical Swelling | Day 29, Day 57 and Day 85 | Swelling was assessed by using a 4-point scale ranging from 0 to 3 where, 0=no swelling, 1=presence of cross fluctuation of fluid (PCFF), 2=patellar ballotment, and 3=swelling that distort the joint contours (SDJC). |
| Number of Participants With Categorical Tenderness | Day 29, Day 57 and Day 85 | Tenderness was assessed by using a 4-point scale 0 to 3 where, 0= no tenderness, 1= complaint of tenderness, 2=complaint of tenderness with wincing (CTW), and 3=wincing and attempt to withdraw. |
| Number of Participants With Overall Assessment on Study Drug by Investigator | Day 85 | Investigator was completed overall assessment on study drug by using a 5-point scale (-2 to 2; where, -2= very bad, 1= bad, 0=moderate, 1=good and 2=very good). Study drug refers specifically to the randomized treatment received from Day 29 to Day 85. |
Participant flow
Pre-assignment details
A total of 143 participants were given informed consent, out of which 3 participants had screening failure.
Participants by arm
| Arm | Count |
|---|---|
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) Participants received fixed dose combination of tramadol hydrochloride 37.5 milligram (mg) plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of NSAIDs either meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 29 to Day 85. | 73 |
| Tramadol Hydrochloride Plus Acetaminophen Participants received fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 to 3 tablets per day along with meloxicam (7.5 mg or 15 mg once daily) or aceclofenac (100 mg twice daily) from Day 1 to Day 28. Participants who had the numeric rating scale score 4 or less on Day 29 were randomly assigned to the treatment of fixed dose combination of tramadol hydrochloride 37.5 mg plus acetaminophen 325 mg, 1 or 2 tablets 4 times daily from Day 29 to Day 85 (maximum daily dose was 8 tablets). | 67 |
| Total | 140 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 11 | 9 |
| Overall Study | Lost to Follow-up | 4 | 3 |
| Overall Study | Other | 8 | 6 |
| Overall Study | Protocol Violation | 18 | 22 |
| Overall Study | Withdrawal by Subject | 3 | 8 |
Baseline characteristics
| Characteristic | Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Tramadol Hydrochloride Plus Acetaminophen | Total |
|---|---|---|---|
| Age Continuous | 60.0 years STANDARD_DEVIATION 8 | 62.3 years STANDARD_DEVIATION 7.6 | 61.1 years STANDARD_DEVIATION 7.9 |
| Sex: Female, Male Female | 62 Participants | 56 Participants | 118 Participants |
| Sex: Female, Male Male | 11 Participants | 11 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 73 | 12 / 67 |
| serious Total, serious adverse events | 1 / 73 | 0 / 67 |
Outcome results
Primary
Change From Day 29 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score at Day 85
The WOMAC is a self-administered and health status questionnaire designed to capture elements of pain, stiffness and physical impairment in participants with osteoarthritis. It consists of 24 questions (5 questions about pain, 2 about stiffness and 17 about physical function) scored on a visual analog scale (VAS) of 0 to 10 cm (0 cm=no pain to 10 cm=worse pain). Individual question responses are assigned a score between 0=extreme and 4=none. Maximum scores for each element differ and therefore, scores were normalized. Total normalized score ranges from 0=worst to 100=best.
Time frame: Day 29 and Day 85
Population: Full analysis set (FAS) population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Last observation carried forward (LOCF) method was applied.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Change From Day 29 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score at Day 85 | Day 29 | 33.54 units on a scale | Standard Deviation 15.01 |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Change From Day 29 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score at Day 85 | Change at Day 85 | -1.88 units on a scale | Standard Deviation 11.07 |
| Tramadol Hydrochloride Plus Acetaminophen | Change From Day 29 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score at Day 85 | Day 29 | 39.44 units on a scale | Standard Deviation 14.17 |
| Tramadol Hydrochloride Plus Acetaminophen | Change From Day 29 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score at Day 85 | Change at Day 85 | -0.07 units on a scale | Standard Deviation 13.46 |
p-value: 0.4258t-test, 1 sided
Secondary
Change From Day 29 in Pain Intensity Score at Day 85
Pain intensity was evaluated by 11- point numeric rating scale ranging from 0 to 10 where, 0=no pain and 10=pain as bad as you can imagine.
Time frame: Day 29 and Day 85
Population: Full analysis set (FAS) population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Last observation carried forward (LOCF) method was applied. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Change From Day 29 in Pain Intensity Score at Day 85 | Day 29 | 3.82 units on a scale | Standard Deviation 1.22 |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Change From Day 29 in Pain Intensity Score at Day 85 | Change at Day 85 | 0.14 units on a scale | Standard Deviation 1.76 |
| Tramadol Hydrochloride Plus Acetaminophen | Change From Day 29 in Pain Intensity Score at Day 85 | Day 29 | 3.81 units on a scale | Standard Deviation 1.03 |
| Tramadol Hydrochloride Plus Acetaminophen | Change From Day 29 in Pain Intensity Score at Day 85 | Change at Day 85 | 0.83 units on a scale | Standard Deviation 2.02 |
p-value: 0.0628t-test, 1 sided
Secondary
Number of Participants With Categorical Swelling
Swelling was assessed by using a 4-point scale ranging from 0 to 3 where, 0=no swelling, 1=presence of cross fluctuation of fluid (PCFF), 2=patellar ballotment, and 3=swelling that distort the joint contours (SDJC).
Time frame: Day 29, Day 57 and Day 85
Population: FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Categorical Swelling | Day 29; PCFF (n=56, 52) | 4 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Categorical Swelling | Day 85; No swelling (n=55, 56) | 53 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Categorical Swelling | Day 29; No swelling (n=56, 52) | 52 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Categorical Swelling | Day 85; PCFF (n=55, 56) | 1 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Categorical Swelling | Day 57; No swelling (n=47, 41) | 43 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Categorical Swelling | Day 85; Patellar ballotment (n=55, 56) | 1 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Categorical Swelling | Day 57; PCFF (n=47, 41) | 4 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Categorical Swelling | Day 85; Patellar ballotment (n=55, 56) | 1 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Categorical Swelling | Day 57; PCFF (n=47, 41) | 3 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Categorical Swelling | Day 29; No swelling (n=56, 52) | 45 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Categorical Swelling | Day 29; PCFF (n=56, 52) | 7 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Categorical Swelling | Day 57; No swelling (n=47, 41) | 38 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Categorical Swelling | Day 85; No swelling (n=55, 56) | 46 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Categorical Swelling | Day 85; PCFF (n=55, 56) | 9 participants |
Secondary
Number of Participants With Categorical Tenderness
Tenderness was assessed by using a 4-point scale 0 to 3 where, 0= no tenderness, 1= complaint of tenderness, 2=complaint of tenderness with wincing (CTW), and 3=wincing and attempt to withdraw.
Time frame: Day 29, Day 57 and Day 85
Population: FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Categorical Tenderness | Day 29; No tenderness(n=56, 52) | 33 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Categorical Tenderness | Day 29; Complaint of tenderness (n=56, 52) | 22 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Categorical Tenderness | Day 29; CTW (n=56, 52) | 0 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Categorical Tenderness | Day 29; Wincing and attempt to withdraw (n=56, 52) | 1 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Categorical Tenderness | Day 57; No tenderness(n=47, 41) | 33 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Categorical Tenderness | Day 57; Complaint of tenderness (n=47, 41) | 14 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Categorical Tenderness | Day 57; CTW (n=47, 41) | 0 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Categorical Tenderness | Day 57; wincing and attempt to withdraw(n=47, 41) | 0 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Categorical Tenderness | Day 85; No tenderness(n=55, 56) | 39 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Categorical Tenderness | Day 85; Complaint of tenderness (n=55, 56) | 15 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Categorical Tenderness | Day 85; CTW (n=55, 56) | 0 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Categorical Tenderness | Day 85; Wincing and attempt to withdraw(n=55, 56) | 1 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Categorical Tenderness | Day 85; CTW (n=55, 56) | 2 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Categorical Tenderness | Day 29; No tenderness(n=56, 52) | 37 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Categorical Tenderness | Day 57; CTW (n=47, 41) | 1 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Categorical Tenderness | Day 29; Complaint of tenderness (n=56, 52) | 14 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Categorical Tenderness | Day 85; Complaint of tenderness (n=55, 56) | 10 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Categorical Tenderness | Day 29; CTW (n=56, 52) | 1 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Categorical Tenderness | Day 57; wincing and attempt to withdraw(n=47, 41) | 0 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Categorical Tenderness | Day 29; Wincing and attempt to withdraw (n=56, 52) | 0 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Categorical Tenderness | Day 85; Wincing and attempt to withdraw(n=55, 56) | 0 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Categorical Tenderness | Day 57; No tenderness(n=47, 41) | 30 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Categorical Tenderness | Day 85; No tenderness(n=55, 56) | 44 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Categorical Tenderness | Day 57; Complaint of tenderness (n=47, 41) | 10 participants |
Secondary
Number of Participants With Overall Assessment on Study Drug by Investigator
Investigator was completed overall assessment on study drug by using a 5-point scale (-2 to 2; where, -2= very bad, 1= bad, 0=moderate, 1=good and 2=very good). Study drug refers specifically to the randomized treatment received from Day 29 to Day 85.
Time frame: Day 85
Population: FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Overall Assessment on Study Drug by Investigator | Bad | 1 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Overall Assessment on Study Drug by Investigator | Good | 31 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Overall Assessment on Study Drug by Investigator | Moderate | 21 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Overall Assessment on Study Drug by Investigator | Very good | 3 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Overall Assessment on Study Drug by Investigator | Very bad | 1 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Overall Assessment on Study Drug by Investigator | Very good | 2 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Overall Assessment on Study Drug by Investigator | Very bad | 0 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Overall Assessment on Study Drug by Investigator | Bad | 6 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Overall Assessment on Study Drug by Investigator | Moderate | 25 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Overall Assessment on Study Drug by Investigator | Good | 24 participants |
Secondary
Number of Participants With Overall Assessment on Study Drug by Participants
Participants' overall assessment on study drug was done by using a 5-point scale ranging from -2 to 2 where, -2= very bad, 1= bad, 0=moderate, 1=good and 2=very good. Study drug refers specifically to the randomized treatment received from Day 29 to Day 85.
Time frame: Day 85
Population: FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Overall Assessment on Study Drug by Participants | Bad | 2 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Overall Assessment on Study Drug by Participants | Good | 29 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Overall Assessment on Study Drug by Participants | Moderate | 21 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Overall Assessment on Study Drug by Participants | Very good | 4 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Overall Assessment on Study Drug by Participants | Very bad | 1 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Overall Assessment on Study Drug by Participants | Very good | 2 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Overall Assessment on Study Drug by Participants | Very bad | 1 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Overall Assessment on Study Drug by Participants | Bad | 11 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Overall Assessment on Study Drug by Participants | Moderate | 22 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Overall Assessment on Study Drug by Participants | Good | 21 participants |
Secondary
Number of Participants With Pain Relief
Pain relief was assessed by using a 6-point scale ranging from -1 to 4 where, -1=pain aggravated, 0=no change, 1=slightly relieved, 2=moderately relieved, 3=considerably relieved, and 4=pain completely disappeared. Participants with pain slightly relieved, moderately relieved and completely disappeared were considered as pain relieved.
Time frame: Day 29, Day 57 and Day 85
Population: FAS population included all randomly assigned participants excluding those who violated the major eligibility criteria or had no data at all after randomization. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Pain Relief | Day 29; Pain relieved (n=56, 52) | 49 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Pain Relief | Day 57; Pain relieved (n=47, 41) | 32 participants |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) | Number of Participants With Pain Relief | Day 85; Pain relieved (n=55, 56) | 42 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Pain Relief | Day 29; Pain relieved (n=56, 52) | 42 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Pain Relief | Day 57; Pain relieved (n=47, 41) | 28 participants |
| Tramadol Hydrochloride Plus Acetaminophen | Number of Participants With Pain Relief | Day 85; Pain relieved (n=55, 56) | 35 participants |
p-value: 0.0131Fisher Exact
p-value: 0.9834Chi-squared
p-value: 0.1131Chi-squared