Acute Pain
Conditions
Keywords
Moderate to severe acute pain, Postoperative pain, Third molar extraction, Analgesics, Nefopam, Paracetamol, Multimodal analgesia, Fixed drug combination
Brief summary
This study aims to evaluate the analgesic efficacy of single and multiple doses of a new fixed dose combination of nefopam hydrochloride 30 mg and paracetamol 500mg taken orally in comparison to each single component.
Interventions
COMBINATION_PRODUCTnefopam hydrochloride 30mg / paracetamol 500mg X2
The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
DRUGParacetamol 500 Mg Oral Tablet X2
The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
DRUGNefopam HCl 30 MG Oral Tablet X2
The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
Sponsors
Excelya
Unither Pharmaceuticals, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind. Participants, investigators, and all persons involved in the conduct, data management, and analysis of the study will be fully blinded to the participant's treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Male and female patient aged from 18 years up to 65 years, * Patient scheduled to undergo the surgical removal of at least one fully or partially impacted third mandibular molar requiring bone removal under short-acting local anaesthetic (mepivacaine or lidocaine) with or without vasoconstrictor, * Patient weighing \> 50 kg, * Patient who has signed a written informed consent prior to any study-related procedures. Additional inclusion criteria after surgery (randomization): 1. Patient experiencing moderate to severe pain within 4 hours after the dental extraction, defined by a baseline pain intensity Visual Analogic Scale (VAS) score ≥ 50 mm, 2. Third molar extraction(s) completed without any immediate complication, that in the opinion of the investigator, would interfere with the study conduct and/or assessments (e.g., suspected neurosensory complication, incomplete removal of tooth) Main
Exclusion criteria
* Patient treated by analgesics or nonsteroidal anti-inflammatory drugs (NSAIDs) within 3 days preceding the day of randomization or within 5 times the elimination half-life whichever the longest, * Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception, * Patient with a history of convulsive disorders, * Patient taking mono-amine-oxidase (MAO) inhibitors (including but not limited to selegiline, isocarboxazid, tranylcypromine, phenelzine…), * Patient with an abnormal cardiac condition: medically significant disorders of cardiac rate and/or rhythm, * Patient with known anaemia, * Patient with known pulmonary disease, * Patient with known active gastric or duodenal ulcer or a history of recurrent gastrointestinal ulcer/bleeding, * Patient with known glaucoma, * Patients with a prostatic hyperplasia or urinary retention, * Patient with current or chronic history of liver disease, or known hepatic or biliary abnormalities, * Patient with a current or chronic history of severe renal impairment (glomerular filtration below 30 mL/min),
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Onset of Pain Relief | during the first 6 hours | Score of pain intensity will be assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240, T300, T360 min). The time point of the first assessment obtaining a score ≤ 30 mm will be retained as time score of onset of pain relief. |
| Ranked Endpoints : 1. Sum of Pain Intensity Differences at 6 Hours (SPID0-6h) | 6 hours post-dose | Pain intensity difference (PID) will be calculated using the score of pain intensity assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240, T300, T360 min,) after the first Investigational Medicinal Product (IMP) intake and/or right before first intake of rescue medication using a 100-mm Visual Analogic Scale (VAS) compared to baseline. Calculation: Sum of Pain intensity difference (SPID) is the time-weighted summary measure of the total area under the pain intensity difference (PID) curve that integrates serial assessments of pain during x times after the first Investigational Medicinal Product SPID0-6h= SPID0-30min+SPID30min-45min+SPID45min-1h+SPID1h-1h30+SPID1h30-2h+SPID2h-2h30+SPID2h30-3h+SPID3h-4h+SPID4h-5h+SPID5h-6h With: SPIDTime1-Time2 = (PID Theoretical Time1 + PID Theoretical Time2) \* (Theoretical Time2- Theoretical Time1) / 2 SPID min 0-6h = 0 SPID max 0-6h = 36000 The lower score mean a better score |
| Total Pain Relief at 6 Hours (TOTPAR0-6h) | 6 hours post-dose | Pain Relief will be assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240, T300, T360 min) after the first IMP intake and/or right before first intake of rescue medication using a 5-point verbal rating scale (VRS). Calculation: TOTPAR is the time-weighted summary measure of the total area under the pain release difference curve that integrates serial assessments of pain release during x times after the first Investigational Medicinal Product TOTPAR0-6h=TOTPAR0-30min+TOTPAR30min-45min+TOTPAR45min-1h+TOTPAR1h-1h30+TOTPAR1h30-2h+TOTPAR2h-2h30+TOTPAR2h30-3h+ TOTPAR 3h-4h+ TOTPAR 4h-5h+ TOTPAR 5h-6h With: TOTPARTime1-Time2 = (PAR Time1 + PAR Time2) \* (Time2-Time1) / 2 And with the score of pain relief at T0 = 0 (none) TOTPAR min 0-6h = 0 TOTPAR max 0-6h = 1800 The higher score mean a better outcome |
| Proportion of Responder Patients | 6 hours post-dose | A responder patient is a subject who achieves a reduction of 50% of pain intensity compared to baseline. |
| The Patient's Global Impression of Change (PGIC) Questionnaire | 6 hours post-dose | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to the Second Investigational Medicinal Product (IMP) Intake | Up to 5 days after first dose | — |
| Participant Having Taken a Rescue Analgesic Treatment | Up to 10 days after first dose | — |
| Sum of Pain Intensity Differences | At days 1, 2, 3, 4 and 5 | Pain Intensity Difference (PID) will be calculated using the score of pain intensity assessed by the patient at defined time points using a 100-mm visual Analog Scale (VAS) compared to baseline. Calculation: Sum of Pain Intensity Difference (SPID) is the time-weighted summary measure of the total area under the pain intensity difference curve that integrates serial assessments of pain during x times after the first Investigational Medicinal Product With: SPIDTime1-Time2 = (VAS Theoretical Time1 + VAS Theoretical Time2) \* (Theoretical Time2- Theoretical Time1) / 2 SPID min 0-any time = 0 SPID max 0-day 1 = 144000 ; SPID max 0-day 2 = 288000 ; SPID max 0-day 3 = 432000 ; SPID max 0-day 4 = 576000 ; SPID max 0-day 5 = 720000 ; The lower score means a better outcome |
| Proportion of Patients Having Taken a Rescue Analgesic Treatment Throughout the Study. | Up to 10 days after first dose | — |
| Mean Duration Under Rescue Medication Over the 5 Days. | Up to 5 days after first dose | — |
| Number of Investigational Medicinal Product (IMP) Intakes | Up to 5 days after first dose | — |
| Patient's Global Impression of Change (PGIC) Score | Up to 10 days after first dose | — |
| The Total Dose of Rescue Medication Taken. | Up to 10 days after first dose | — |
| Total Pain Relief at 1 Hour (TOTPAR0-1h), 2 Hours (TOTPAR0-2h), 3 Hours (TOTPAR0-3h), and 4 Hours (TOTPAR0-4h) | At 1 hour, 2 hours, 3 hours, and 4 hours | Pain relief (PAR) will be assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240 min) after the first IMP intake and/or right before first intake of rescue medication using a 5-point verbal rating scale Calculation: TOTPAR is the time-weighted summary measure of the total area under the pain release difference curve that integrates serial assessments of pain release during x times after the first Investigational Medicinal Product TOTPAR0-6h=TOTPAR0-30min+TOTPAR30min-45min+TOTPAR45min-1h+TOTPAR1h-1h30+TOTPAR1h30-2h+TOTPAR2h-2h30+TOTPAR2h30-3h+ TOTPAR 3h-4h+ TOTPAR 4h-5h+ TOTPAR 5h-6h With: TOTPARTime1-Time2 = (PAR Time1 + PAR Time2) \* (Time2-Time1) / 2 And with the score of pain relief at T0 = 0 (none) TOTPAR min 0-any time = 0 TOTPAR max 0-1h = 300 ; TOTPAR max 0-2h = 600 ;TOTPAR max 0-3h = 900 ;TOTPAR max 0-4h = 1200 ; The higher score mean a better outcome |
| Sum of Pain Intensity Differences at 1 Hour (SPID0-1h), 2 Hours (SPID0-2h), 3 Hours (SPID0-3h), and 4 Hours (SPID0-4h) | At 1 hour, 2 hours, 3 hours, and 4 hours | PID will be calculated using the score of pain intensity assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240 min) after the first IMP intake and/or right before first intake of rescue medication using a 100-mm VAS compared to baseline. Calculation: SPID is the time-weighted summary measure of the total area under the pain intensity difference curve that integrates serial assessments of pain during x times after the first IMP SPID0-4h= SPID0-30min+SPID30min-45min+SPID45min-1h+SPID1h-1h30+SPID1h30-2h+SPID2h-2h30+SPID2h30-3h+SPID3h-4h With: SPIDTime1-Time2 = (PID Theoretical Time1 + PID Theoretical Time2) \* (Theoretical Time2- Theoretical Time1) / 2 SPID min 0-any time = 0 SPID max 0-1h = 6000 ; SPID max 0-2h = 12000; SPID max 0-3h = 18000; SPID max 0-4h = 24000 The lower score mean a better score |
| The Pain Intensity Differences (PID) Assessment | At each timepoint: 30min, At 45min, until at 360 min post-dose | PID will be calculated using the scores of pain intensity (VAS) at each time point compared to baseline. PID30min = VAS of pain intensity 30min - VAS of pain intensity baseline PID min = 0 / PID max = 100 A higher PID is a better outcome |
| Proportion of Responder Patients. | At 1 hour, 2 hours, 3 hours and 4 hours. | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Adverse Events (Serious and Non-serious Adverse Events). | Up to 10 days after first dose | = Number of Events |
Countries
Belgium, France, Hungary, Russia, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) Each dose: 2 tablets (included in masking capsule)
nefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day. | 107 |
| Paracetamol 500 mg (X2) Each dose: 2 tablets (included in masking capsule)
Paracetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day. | 108 |
| Nefopam Hydrochloride 30 mg (X2) Each dose: 2 tablets (included in masking capsule)
Nefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day. | 106 |
| Total | 321 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Paracetamol 500 mg (X2) | Nefopam Hydrochloride 30 mg (X2) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 107 Participants | 108 Participants | 106 Participants | 321 Participants |
| Age, Continuous | 27.8 years STANDARD_DEVIATION 7.8 | 28.3 years STANDARD_DEVIATION 7.9 | 28.3 years STANDARD_DEVIATION 7.8 | 28.1 years STANDARD_DEVIATION 7.8 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment Belgium | 8 Participants | 9 Participants | 7 Participants | 24 Participants |
| Region of Enrollment France | 19 Participants | 18 Participants | 19 Participants | 56 Participants |
| Region of Enrollment Hungary | 33 Participants | 31 Participants | 33 Participants | 97 Participants |
| Region of Enrollment Russia | 17 Participants | 20 Participants | 16 Participants | 53 Participants |
| Region of Enrollment United Kingdom | 30 Participants | 30 Participants | 31 Participants | 91 Participants |
| Sex: Female, Male Female | 62 Participants | 61 Participants | 61 Participants | 184 Participants |
| Sex: Female, Male Male | 45 Participants | 47 Participants | 45 Participants | 137 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 107 | 0 / 108 | 0 / 106 |
| other Total, other adverse events | 39 / 107 | 25 / 108 | 35 / 106 |
| serious Total, serious adverse events | 0 / 107 | 0 / 108 | 0 / 106 |
Outcome results
Primary
Proportion of Responder Patients
A responder patient is a subject who achieves a reduction of 50% of pain intensity compared to baseline.
Time frame: 6 hours post-dose
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Proportion of Responder Patients | 47 Participants |
| Paracetamol 500 mg (X2) | Proportion of Responder Patients | 43 Participants |
| Nefopam Hydrochloride 30 mg (X2) | Proportion of Responder Patients | 35 Participants |
Primary
Ranked Endpoints : 1. Sum of Pain Intensity Differences at 6 Hours (SPID0-6h)
Pain intensity difference (PID) will be calculated using the score of pain intensity assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240, T300, T360 min,) after the first Investigational Medicinal Product (IMP) intake and/or right before first intake of rescue medication using a 100-mm Visual Analogic Scale (VAS) compared to baseline. Calculation: Sum of Pain intensity difference (SPID) is the time-weighted summary measure of the total area under the pain intensity difference (PID) curve that integrates serial assessments of pain during x times after the first Investigational Medicinal Product SPID0-6h= SPID0-30min+SPID30min-45min+SPID45min-1h+SPID1h-1h30+SPID1h30-2h+SPID2h-2h30+SPID2h30-3h+SPID3h-4h+SPID4h-5h+SPID5h-6h With: SPIDTime1-Time2 = (PID Theoretical Time1 + PID Theoretical Time2) \* (Theoretical Time2- Theoretical Time1) / 2 SPID min 0-6h = 0 SPID max 0-6h = 36000 The lower score mean a better score
Time frame: 6 hours post-dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Ranked Endpoints : 1. Sum of Pain Intensity Differences at 6 Hours (SPID0-6h) | 8955.4 score on a scale | Standard Deviation 8751.8 |
| Paracetamol 500 mg (X2) | Ranked Endpoints : 1. Sum of Pain Intensity Differences at 6 Hours (SPID0-6h) | 8458.0 score on a scale | Standard Deviation 8831.7 |
| Nefopam Hydrochloride 30 mg (X2) | Ranked Endpoints : 1. Sum of Pain Intensity Differences at 6 Hours (SPID0-6h) | 5290.7 score on a scale | Standard Deviation 9109.3 |
p-value: 0.0031Mixed Models Analysis
p-value: 0.6787Mixed Models Analysis
Primary
The Onset of Pain Relief
Score of pain intensity will be assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240, T300, T360 min). The time point of the first assessment obtaining a score ≤ 30 mm will be retained as time score of onset of pain relief.
Time frame: during the first 6 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | The Onset of Pain Relief | 76 Participants |
| Paracetamol 500 mg (X2) | The Onset of Pain Relief | 74 Participants |
| Nefopam Hydrochloride 30 mg (X2) | The Onset of Pain Relief | 58 Participants |
Primary
The Patient's Global Impression of Change (PGIC) Questionnaire
Time frame: 6 hours post-dose
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | The Patient's Global Impression of Change (PGIC) Questionnaire | MUCH IMPROVED | 39 Participants |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | The Patient's Global Impression of Change (PGIC) Questionnaire | MINIMALLY WORSE | 10 Participants |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | The Patient's Global Impression of Change (PGIC) Questionnaire | NO CHANGE | 14 Participants |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | The Patient's Global Impression of Change (PGIC) Questionnaire | VERY MUCH IMPROVED | 11 Participants |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | The Patient's Global Impression of Change (PGIC) Questionnaire | VERY MUCH WORSE | 1 Participants |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | The Patient's Global Impression of Change (PGIC) Questionnaire | MUCH WORSE | 7 Participants |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | The Patient's Global Impression of Change (PGIC) Questionnaire | MINIMALLY IMPROVED | 22 Participants |
| Paracetamol 500 mg (X2) | The Patient's Global Impression of Change (PGIC) Questionnaire | NO CHANGE | 12 Participants |
| Paracetamol 500 mg (X2) | The Patient's Global Impression of Change (PGIC) Questionnaire | VERY MUCH IMPROVED | 14 Participants |
| Paracetamol 500 mg (X2) | The Patient's Global Impression of Change (PGIC) Questionnaire | MUCH IMPROVED | 29 Participants |
| Paracetamol 500 mg (X2) | The Patient's Global Impression of Change (PGIC) Questionnaire | MINIMALLY IMPROVED | 24 Participants |
| Paracetamol 500 mg (X2) | The Patient's Global Impression of Change (PGIC) Questionnaire | MINIMALLY WORSE | 12 Participants |
| Paracetamol 500 mg (X2) | The Patient's Global Impression of Change (PGIC) Questionnaire | MUCH WORSE | 9 Participants |
| Paracetamol 500 mg (X2) | The Patient's Global Impression of Change (PGIC) Questionnaire | VERY MUCH WORSE | 0 Participants |
| Nefopam Hydrochloride 30 mg (X2) | The Patient's Global Impression of Change (PGIC) Questionnaire | MINIMALLY WORSE | 7 Participants |
| Nefopam Hydrochloride 30 mg (X2) | The Patient's Global Impression of Change (PGIC) Questionnaire | MUCH IMPROVED | 30 Participants |
| Nefopam Hydrochloride 30 mg (X2) | The Patient's Global Impression of Change (PGIC) Questionnaire | VERY MUCH WORSE | 1 Participants |
| Nefopam Hydrochloride 30 mg (X2) | The Patient's Global Impression of Change (PGIC) Questionnaire | MUCH WORSE | 8 Participants |
| Nefopam Hydrochloride 30 mg (X2) | The Patient's Global Impression of Change (PGIC) Questionnaire | NO CHANGE | 13 Participants |
| Nefopam Hydrochloride 30 mg (X2) | The Patient's Global Impression of Change (PGIC) Questionnaire | MINIMALLY IMPROVED | 31 Participants |
| Nefopam Hydrochloride 30 mg (X2) | The Patient's Global Impression of Change (PGIC) Questionnaire | VERY MUCH IMPROVED | 11 Participants |
Primary
Total Pain Relief at 6 Hours (TOTPAR0-6h)
Pain Relief will be assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240, T300, T360 min) after the first IMP intake and/or right before first intake of rescue medication using a 5-point verbal rating scale (VRS). Calculation: TOTPAR is the time-weighted summary measure of the total area under the pain release difference curve that integrates serial assessments of pain release during x times after the first Investigational Medicinal Product TOTPAR0-6h=TOTPAR0-30min+TOTPAR30min-45min+TOTPAR45min-1h+TOTPAR1h-1h30+TOTPAR1h30-2h+TOTPAR2h-2h30+TOTPAR2h30-3h+ TOTPAR 3h-4h+ TOTPAR 4h-5h+ TOTPAR 5h-6h With: TOTPARTime1-Time2 = (PAR Time1 + PAR Time2) \* (Time2-Time1) / 2 And with the score of pain relief at T0 = 0 (none) TOTPAR min 0-6h = 0 TOTPAR max 0-6h = 1800 The higher score mean a better outcome
Time frame: 6 hours post-dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Total Pain Relief at 6 Hours (TOTPAR0-6h) | 610.6 score on a scale | Standard Deviation 434.5 |
| Paracetamol 500 mg (X2) | Total Pain Relief at 6 Hours (TOTPAR0-6h) | 602.2 score on a scale | Standard Deviation 383.6 |
| Nefopam Hydrochloride 30 mg (X2) | Total Pain Relief at 6 Hours (TOTPAR0-6h) | 461.4 score on a scale | Standard Deviation 384.5 |
Secondary
Mean Duration Under Rescue Medication Over the 5 Days.
Time frame: Up to 5 days after first dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Mean Duration Under Rescue Medication Over the 5 Days. | 57.9 hours | Standard Deviation 51.5 |
| Paracetamol 500 mg (X2) | Mean Duration Under Rescue Medication Over the 5 Days. | 99.4 hours | Standard Deviation 144.5 |
| Nefopam Hydrochloride 30 mg (X2) | Mean Duration Under Rescue Medication Over the 5 Days. | 61.9 hours | Standard Deviation 42.2 |
Secondary
Number of Investigational Medicinal Product (IMP) Intakes
Time frame: Up to 5 days after first dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Number of Investigational Medicinal Product (IMP) Intakes | 6.4 intake | Standard Deviation 4.5 |
| Paracetamol 500 mg (X2) | Number of Investigational Medicinal Product (IMP) Intakes | 5.8 intake | Standard Deviation 4.2 |
| Nefopam Hydrochloride 30 mg (X2) | Number of Investigational Medicinal Product (IMP) Intakes | 5.1 intake | Standard Deviation 3.6 |
Secondary
Participant Having Taken a Rescue Analgesic Treatment
Time frame: Up to 10 days after first dose
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Participant Having Taken a Rescue Analgesic Treatment | 19 Participants |
| Paracetamol 500 mg (X2) | Participant Having Taken a Rescue Analgesic Treatment | 26 Participants |
| Nefopam Hydrochloride 30 mg (X2) | Participant Having Taken a Rescue Analgesic Treatment | 35 Participants |
Secondary
Patient's Global Impression of Change (PGIC) Score
Time frame: Up to 10 days after first dose
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Patient's Global Impression of Change (PGIC) Score | VERY MUCH IMPROVED | 36 Participants |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Patient's Global Impression of Change (PGIC) Score | MUCH IMPROVED | 40 Participants |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Patient's Global Impression of Change (PGIC) Score | MINIMALLY IMPROVED | 11 Participants |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Patient's Global Impression of Change (PGIC) Score | NO CHANGE | 9 Participants |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Patient's Global Impression of Change (PGIC) Score | MINIMALLY WORSE | 3 Participants |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Patient's Global Impression of Change (PGIC) Score | MUCH WORSE | 2 Participants |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Patient's Global Impression of Change (PGIC) Score | VERY MUCH WORSE | 1 Participants |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Patient's Global Impression of Change (PGIC) Score | Missing | 5 Participants |
| Paracetamol 500 mg (X2) | Patient's Global Impression of Change (PGIC) Score | MINIMALLY IMPROVED | 9 Participants |
| Paracetamol 500 mg (X2) | Patient's Global Impression of Change (PGIC) Score | VERY MUCH WORSE | 0 Participants |
| Paracetamol 500 mg (X2) | Patient's Global Impression of Change (PGIC) Score | NO CHANGE | 4 Participants |
| Paracetamol 500 mg (X2) | Patient's Global Impression of Change (PGIC) Score | MINIMALLY WORSE | 1 Participants |
| Paracetamol 500 mg (X2) | Patient's Global Impression of Change (PGIC) Score | MUCH WORSE | 3 Participants |
| Paracetamol 500 mg (X2) | Patient's Global Impression of Change (PGIC) Score | VERY MUCH IMPROVED | 39 Participants |
| Paracetamol 500 mg (X2) | Patient's Global Impression of Change (PGIC) Score | MUCH IMPROVED | 46 Participants |
| Paracetamol 500 mg (X2) | Patient's Global Impression of Change (PGIC) Score | Missing | 6 Participants |
| Nefopam Hydrochloride 30 mg (X2) | Patient's Global Impression of Change (PGIC) Score | MINIMALLY IMPROVED | 16 Participants |
| Nefopam Hydrochloride 30 mg (X2) | Patient's Global Impression of Change (PGIC) Score | MUCH IMPROVED | 40 Participants |
| Nefopam Hydrochloride 30 mg (X2) | Patient's Global Impression of Change (PGIC) Score | VERY MUCH IMPROVED | 34 Participants |
| Nefopam Hydrochloride 30 mg (X2) | Patient's Global Impression of Change (PGIC) Score | NO CHANGE | 5 Participants |
| Nefopam Hydrochloride 30 mg (X2) | Patient's Global Impression of Change (PGIC) Score | VERY MUCH WORSE | 2 Participants |
| Nefopam Hydrochloride 30 mg (X2) | Patient's Global Impression of Change (PGIC) Score | MUCH WORSE | 1 Participants |
| Nefopam Hydrochloride 30 mg (X2) | Patient's Global Impression of Change (PGIC) Score | MINIMALLY WORSE | 1 Participants |
| Nefopam Hydrochloride 30 mg (X2) | Patient's Global Impression of Change (PGIC) Score | Missing | 7 Participants |
Secondary
Proportion of Patients Having Taken a Rescue Analgesic Treatment Throughout the Study.
Time frame: Up to 10 days after first dose
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Proportion of Patients Having Taken a Rescue Analgesic Treatment Throughout the Study. | 19 Participants |
| Paracetamol 500 mg (X2) | Proportion of Patients Having Taken a Rescue Analgesic Treatment Throughout the Study. | 26 Participants |
| Nefopam Hydrochloride 30 mg (X2) | Proportion of Patients Having Taken a Rescue Analgesic Treatment Throughout the Study. | 35 Participants |
Secondary
Proportion of Responder Patients.
Time frame: At 1 hour, 2 hours, 3 hours and 4 hours.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Proportion of Responder Patients. | RESPONDER AT 1 HOUR, | 44 Participants |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Proportion of Responder Patients. | RESPONDER AT 2 HOUR, | 57 Participants |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Proportion of Responder Patients. | RESPONDER AT 3 HOUR, | 61 Participants |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Proportion of Responder Patients. | RESPONDER AT 4 HOUR, | 54 Participants |
| Paracetamol 500 mg (X2) | Proportion of Responder Patients. | RESPONDER AT 4 HOUR, | 50 Participants |
| Paracetamol 500 mg (X2) | Proportion of Responder Patients. | RESPONDER AT 1 HOUR, | 45 Participants |
| Paracetamol 500 mg (X2) | Proportion of Responder Patients. | RESPONDER AT 3 HOUR, | 53 Participants |
| Paracetamol 500 mg (X2) | Proportion of Responder Patients. | RESPONDER AT 2 HOUR, | 54 Participants |
| Nefopam Hydrochloride 30 mg (X2) | Proportion of Responder Patients. | RESPONDER AT 4 HOUR, | 37 Participants |
| Nefopam Hydrochloride 30 mg (X2) | Proportion of Responder Patients. | RESPONDER AT 2 HOUR, | 38 Participants |
| Nefopam Hydrochloride 30 mg (X2) | Proportion of Responder Patients. | RESPONDER AT 3 HOUR, | 34 Participants |
| Nefopam Hydrochloride 30 mg (X2) | Proportion of Responder Patients. | RESPONDER AT 1 HOUR, | 34 Participants |
Secondary
Sum of Pain Intensity Differences
Pain Intensity Difference (PID) will be calculated using the score of pain intensity assessed by the patient at defined time points using a 100-mm visual Analog Scale (VAS) compared to baseline. Calculation: Sum of Pain Intensity Difference (SPID) is the time-weighted summary measure of the total area under the pain intensity difference curve that integrates serial assessments of pain during x times after the first Investigational Medicinal Product With: SPIDTime1-Time2 = (VAS Theoretical Time1 + VAS Theoretical Time2) \* (Theoretical Time2- Theoretical Time1) / 2 SPID min 0-any time = 0 SPID max 0-day 1 = 144000 ; SPID max 0-day 2 = 288000 ; SPID max 0-day 3 = 432000 ; SPID max 0-day 4 = 576000 ; SPID max 0-day 5 = 720000 ; The lower score means a better outcome
Time frame: At days 1, 2, 3, 4 and 5
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Sum of Pain Intensity Differences | SPID Day 4 | 84261.6 score on a scale | Standard Deviation 84118.3 |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Sum of Pain Intensity Differences | SPID Day 3 | 70094.2 score on a scale | Standard Deviation 70059.9 |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Sum of Pain Intensity Differences | SPID Day 1 | 23306.5 score on a scale | Standard Deviation 23707.8 |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Sum of Pain Intensity Differences | SPID Day 2 | 48792.4 score on a scale | Standard Deviation 48167.2 |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Sum of Pain Intensity Differences | SPID Day 5 | 92644.0 score on a scale | Standard Deviation 96128.8 |
| Paracetamol 500 mg (X2) | Sum of Pain Intensity Differences | SPID Day 3 | 68351.5 score on a scale | Standard Deviation 71111 |
| Paracetamol 500 mg (X2) | Sum of Pain Intensity Differences | SPID Day 1 | 22173.7 score on a scale | Standard Deviation 25105 |
| Paracetamol 500 mg (X2) | Sum of Pain Intensity Differences | SPID Day 2 | 44604.7 score on a scale | Standard Deviation 48227.7 |
| Paracetamol 500 mg (X2) | Sum of Pain Intensity Differences | SPID Day 4 | 84781.0 score on a scale | Standard Deviation 90576.9 |
| Paracetamol 500 mg (X2) | Sum of Pain Intensity Differences | SPID Day 5 | 96134.2 score on a scale | Standard Deviation 107774.7 |
| Nefopam Hydrochloride 30 mg (X2) | Sum of Pain Intensity Differences | SPID Day 5 | 78299.5 score on a scale | Standard Deviation 106041.1 |
| Nefopam Hydrochloride 30 mg (X2) | Sum of Pain Intensity Differences | SPID Day 4 | 73960.7 score on a scale | Standard Deviation 96674.9 |
| Nefopam Hydrochloride 30 mg (X2) | Sum of Pain Intensity Differences | SPID Day 1 | 19910.3 score on a scale | Standard Deviation 28416.2 |
| Nefopam Hydrochloride 30 mg (X2) | Sum of Pain Intensity Differences | SPID Day 3 | 61347.0 score on a scale | Standard Deviation 75669.6 |
| Nefopam Hydrochloride 30 mg (X2) | Sum of Pain Intensity Differences | SPID Day 2 | 42972.1 score on a scale | Standard Deviation 52821.9 |
Secondary
Sum of Pain Intensity Differences at 1 Hour (SPID0-1h), 2 Hours (SPID0-2h), 3 Hours (SPID0-3h), and 4 Hours (SPID0-4h)
PID will be calculated using the score of pain intensity assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240 min) after the first IMP intake and/or right before first intake of rescue medication using a 100-mm VAS compared to baseline. Calculation: SPID is the time-weighted summary measure of the total area under the pain intensity difference curve that integrates serial assessments of pain during x times after the first IMP SPID0-4h= SPID0-30min+SPID30min-45min+SPID45min-1h+SPID1h-1h30+SPID1h30-2h+SPID2h-2h30+SPID2h30-3h+SPID3h-4h With: SPIDTime1-Time2 = (PID Theoretical Time1 + PID Theoretical Time2) \* (Theoretical Time2- Theoretical Time1) / 2 SPID min 0-any time = 0 SPID max 0-1h = 6000 ; SPID max 0-2h = 12000; SPID max 0-3h = 18000; SPID max 0-4h = 24000 The lower score mean a better score
Time frame: At 1 hour, 2 hours, 3 hours, and 4 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Sum of Pain Intensity Differences at 1 Hour (SPID0-1h), 2 Hours (SPID0-2h), 3 Hours (SPID0-3h), and 4 Hours (SPID0-4h) | SPID0-1h | 743.7 score on a scale | Standard Deviation 1075.2 |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Sum of Pain Intensity Differences at 1 Hour (SPID0-1h), 2 Hours (SPID0-2h), 3 Hours (SPID0-3h), and 4 Hours (SPID0-4h) | SPID0-2h | 2405.9 score on a scale | Standard Deviation 2553 |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Sum of Pain Intensity Differences at 1 Hour (SPID0-1h), 2 Hours (SPID0-2h), 3 Hours (SPID0-3h), and 4 Hours (SPID0-4h) | SPID0-3h | 4281.3 score on a scale | Standard Deviation 4071.1 |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Sum of Pain Intensity Differences at 1 Hour (SPID0-1h), 2 Hours (SPID0-2h), 3 Hours (SPID0-3h), and 4 Hours (SPID0-4h) | SPID0-4h | 6039.8 score on a scale | Standard Deviation 5636.4 |
| Paracetamol 500 mg (X2) | Sum of Pain Intensity Differences at 1 Hour (SPID0-1h), 2 Hours (SPID0-2h), 3 Hours (SPID0-3h), and 4 Hours (SPID0-4h) | SPID0-4h | 5786.0 score on a scale | Standard Deviation 5639.1 |
| Paracetamol 500 mg (X2) | Sum of Pain Intensity Differences at 1 Hour (SPID0-1h), 2 Hours (SPID0-2h), 3 Hours (SPID0-3h), and 4 Hours (SPID0-4h) | SPID0-1h | 809.5 score on a scale | Standard Deviation 1017.3 |
| Paracetamol 500 mg (X2) | Sum of Pain Intensity Differences at 1 Hour (SPID0-1h), 2 Hours (SPID0-2h), 3 Hours (SPID0-3h), and 4 Hours (SPID0-4h) | SPID0-3h | 4128.8 score on a scale | Standard Deviation 4022 |
| Paracetamol 500 mg (X2) | Sum of Pain Intensity Differences at 1 Hour (SPID0-1h), 2 Hours (SPID0-2h), 3 Hours (SPID0-3h), and 4 Hours (SPID0-4h) | SPID0-2h | 2418.4 score on a scale | Standard Deviation 2469.2 |
| Nefopam Hydrochloride 30 mg (X2) | Sum of Pain Intensity Differences at 1 Hour (SPID0-1h), 2 Hours (SPID0-2h), 3 Hours (SPID0-3h), and 4 Hours (SPID0-4h) | SPID0-4h | 3467.2 score on a scale | Standard Deviation 6054.1 |
| Nefopam Hydrochloride 30 mg (X2) | Sum of Pain Intensity Differences at 1 Hour (SPID0-1h), 2 Hours (SPID0-2h), 3 Hours (SPID0-3h), and 4 Hours (SPID0-4h) | SPID0-2h | 1487.2 score on a scale | Standard Deviation 2723.5 |
| Nefopam Hydrochloride 30 mg (X2) | Sum of Pain Intensity Differences at 1 Hour (SPID0-1h), 2 Hours (SPID0-2h), 3 Hours (SPID0-3h), and 4 Hours (SPID0-4h) | SPID0-3h | 2486.8 score on a scale | Standard Deviation 4425.5 |
| Nefopam Hydrochloride 30 mg (X2) | Sum of Pain Intensity Differences at 1 Hour (SPID0-1h), 2 Hours (SPID0-2h), 3 Hours (SPID0-3h), and 4 Hours (SPID0-4h) | SPID0-1h | 506.4 score on a scale | Standard Deviation 1042.5 |
Secondary
The Pain Intensity Differences (PID) Assessment
PID will be calculated using the scores of pain intensity (VAS) at each time point compared to baseline. PID30min = VAS of pain intensity 30min - VAS of pain intensity baseline PID min = 0 / PID max = 100 A higher PID is a better outcome
Time frame: At each timepoint: 30min, At 45min, until at 360 min post-dose
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | The Pain Intensity Differences (PID) Assessment | 45 min | -20.1 units on a scale | Standard Deviation 27 |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | The Pain Intensity Differences (PID) Assessment | 30 min | -11.4 units on a scale | Standard Deviation 22.6 |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | The Pain Intensity Differences (PID) Assessment | 360 min | -20.2 units on a scale | Standard Deviation 30.2 |
| Paracetamol 500 mg (X2) | The Pain Intensity Differences (PID) Assessment | 45 min | -19.6 units on a scale | Standard Deviation 24.6 |
| Paracetamol 500 mg (X2) | The Pain Intensity Differences (PID) Assessment | 30 min | -14.8 units on a scale | Standard Deviation 22.3 |
| Paracetamol 500 mg (X2) | The Pain Intensity Differences (PID) Assessment | 360 min | -18.0 units on a scale | Standard Deviation 31.1 |
| Nefopam Hydrochloride 30 mg (X2) | The Pain Intensity Differences (PID) Assessment | 30 min | -8.6 units on a scale | Standard Deviation 20.8 |
| Nefopam Hydrochloride 30 mg (X2) | The Pain Intensity Differences (PID) Assessment | 360 min | -14.6 units on a scale | Standard Deviation 29.2 |
| Nefopam Hydrochloride 30 mg (X2) | The Pain Intensity Differences (PID) Assessment | 45 min | -12.7 units on a scale | Standard Deviation 25.9 |
Secondary
The Total Dose of Rescue Medication Taken.
Time frame: Up to 10 days after first dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | The Total Dose of Rescue Medication Taken. | 7.1 mg | Standard Deviation 5.2 |
| Paracetamol 500 mg (X2) | The Total Dose of Rescue Medication Taken. | 7.3 mg | Standard Deviation 4.5 |
| Nefopam Hydrochloride 30 mg (X2) | The Total Dose of Rescue Medication Taken. | 6.0 mg | Standard Deviation 4 |
Secondary
Time to the Second Investigational Medicinal Product (IMP) Intake
Time frame: Up to 5 days after first dose
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Time to the Second Investigational Medicinal Product (IMP) Intake | 438.5 minutes |
| Paracetamol 500 mg (X2) | Time to the Second Investigational Medicinal Product (IMP) Intake | 429.0 minutes |
| Nefopam Hydrochloride 30 mg (X2) | Time to the Second Investigational Medicinal Product (IMP) Intake | 387.0 minutes |
Secondary
Total Pain Relief at 1 Hour (TOTPAR0-1h), 2 Hours (TOTPAR0-2h), 3 Hours (TOTPAR0-3h), and 4 Hours (TOTPAR0-4h)
Pain relief (PAR) will be assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240 min) after the first IMP intake and/or right before first intake of rescue medication using a 5-point verbal rating scale Calculation: TOTPAR is the time-weighted summary measure of the total area under the pain release difference curve that integrates serial assessments of pain release during x times after the first Investigational Medicinal Product TOTPAR0-6h=TOTPAR0-30min+TOTPAR30min-45min+TOTPAR45min-1h+TOTPAR1h-1h30+TOTPAR1h30-2h+TOTPAR2h-2h30+TOTPAR2h30-3h+ TOTPAR 3h-4h+ TOTPAR 4h-5h+ TOTPAR 5h-6h With: TOTPARTime1-Time2 = (PAR Time1 + PAR Time2) \* (Time2-Time1) / 2 And with the score of pain relief at T0 = 0 (none) TOTPAR min 0-any time = 0 TOTPAR max 0-1h = 300 ; TOTPAR max 0-2h = 600 ;TOTPAR max 0-3h = 900 ;TOTPAR max 0-4h = 1200 ; The higher score mean a better outcome
Time frame: At 1 hour, 2 hours, 3 hours, and 4 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Total Pain Relief at 1 Hour (TOTPAR0-1h), 2 Hours (TOTPAR0-2h), 3 Hours (TOTPAR0-3h), and 4 Hours (TOTPAR0-4h) | TOTPAR0-1h | 60.2 score on a scale | Standard Deviation 54.2 |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Total Pain Relief at 1 Hour (TOTPAR0-1h), 2 Hours (TOTPAR0-2h), 3 Hours (TOTPAR0-3h), and 4 Hours (TOTPAR0-4h) | TOTPAR0-2h | 170.0 score on a scale | Standard Deviation 130.6 |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Total Pain Relief at 1 Hour (TOTPAR0-1h), 2 Hours (TOTPAR0-2h), 3 Hours (TOTPAR0-3h), and 4 Hours (TOTPAR0-4h) | TOTPAR0-3h | 285.4 score on a scale | Standard Deviation 210.5 |
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Total Pain Relief at 1 Hour (TOTPAR0-1h), 2 Hours (TOTPAR0-2h), 3 Hours (TOTPAR0-3h), and 4 Hours (TOTPAR0-4h) | TOTPAR0-4h | 399.7 score on a scale | Standard Deviation 288.4 |
| Paracetamol 500 mg (X2) | Total Pain Relief at 1 Hour (TOTPAR0-1h), 2 Hours (TOTPAR0-2h), 3 Hours (TOTPAR0-3h), and 4 Hours (TOTPAR0-4h) | TOTPAR0-4h | 412.2 score on a scale | Standard Deviation 252.2 |
| Paracetamol 500 mg (X2) | Total Pain Relief at 1 Hour (TOTPAR0-1h), 2 Hours (TOTPAR0-2h), 3 Hours (TOTPAR0-3h), and 4 Hours (TOTPAR0-4h) | TOTPAR0-1h | 69.4 score on a scale | Standard Deviation 49.5 |
| Paracetamol 500 mg (X2) | Total Pain Relief at 1 Hour (TOTPAR0-1h), 2 Hours (TOTPAR0-2h), 3 Hours (TOTPAR0-3h), and 4 Hours (TOTPAR0-4h) | TOTPAR0-3h | 300.8 score on a scale | Standard Deviation 184.7 |
| Paracetamol 500 mg (X2) | Total Pain Relief at 1 Hour (TOTPAR0-1h), 2 Hours (TOTPAR0-2h), 3 Hours (TOTPAR0-3h), and 4 Hours (TOTPAR0-4h) | TOTPAR0-2h | 183.0 score on a scale | Standard Deviation 115.7 |
| Nefopam Hydrochloride 30 mg (X2) | Total Pain Relief at 1 Hour (TOTPAR0-1h), 2 Hours (TOTPAR0-2h), 3 Hours (TOTPAR0-3h), and 4 Hours (TOTPAR0-4h) | TOTPAR0-4h | 298.4 score on a scale | Standard Deviation 254.4 |
| Nefopam Hydrochloride 30 mg (X2) | Total Pain Relief at 1 Hour (TOTPAR0-1h), 2 Hours (TOTPAR0-2h), 3 Hours (TOTPAR0-3h), and 4 Hours (TOTPAR0-4h) | TOTPAR0-2h | 133.2 score on a scale | Standard Deviation 116.9 |
| Nefopam Hydrochloride 30 mg (X2) | Total Pain Relief at 1 Hour (TOTPAR0-1h), 2 Hours (TOTPAR0-2h), 3 Hours (TOTPAR0-3h), and 4 Hours (TOTPAR0-4h) | TOTPAR0-3h | 216.3 score on a scale | Standard Deviation 185.7 |
| Nefopam Hydrochloride 30 mg (X2) | Total Pain Relief at 1 Hour (TOTPAR0-1h), 2 Hours (TOTPAR0-2h), 3 Hours (TOTPAR0-3h), and 4 Hours (TOTPAR0-4h) | TOTPAR0-1h | 49.7 score on a scale | Standard Deviation 47.7 |
Other Pre-specified
Occurrence of Adverse Events (Serious and Non-serious Adverse Events).
= Number of Events
Time frame: Up to 10 days after first dose
Population: All population has been analysed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | Occurrence of Adverse Events (Serious and Non-serious Adverse Events). | 39 Adverse Event |
| Paracetamol 500 mg (X2) | Occurrence of Adverse Events (Serious and Non-serious Adverse Events). | 25 Adverse Event |
| Nefopam Hydrochloride 30 mg (X2) | Occurrence of Adverse Events (Serious and Non-serious Adverse Events). | 35 Adverse Event |