Trial · NCT04622735
Nefopam/Paracetamol Fixed Dose Combination in Acute Pain After Impacted Third Molar Extraction
NCT04622735, Phase 3, Completed, Unither Pharmaceuticals, France; results first posted 2024-11-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Nefopam/Paracetamol Fixed Dose Combination in Acute Pain After Impacted Third Molar Extraction. Trials, record NCT04622735. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04622735
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nefopam/Paracetamol Fixed Dose Combination in Acute Pain After Impacted Third Molar Extraction
- NCT number
- NCT04622735
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 321 participants, actual
- Lead sponsor
- Unither Pharmaceuticals, France
- Conditions
- Acute Pain
- Interventions
- nefopam hydrochloride 30mg / paracetamol 500mg X2, Paracetamol 500 Mg Oral Tablet X2, Nefopam HCl 30 MG Oral Tablet X2
- First posted
- 2020-11-10
- Last updated
- 2024-11-27
- Results first posted
- 2024-11-27
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 |
| Primary | 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 |
| Primary | 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. |
| Primary | The Patient's Global Impression of Change (PGIC) Questionnaire | 6 hours post-dose | |
| Primary | 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. |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | Proportion of Responder Patients. | At 1 hour, 2 hours, 3 hours and 4 hours. | |
| Secondary | Time to the Second Investigational Medicinal Product (IMP) Intake | Up to 5 days after first dose |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ranked Endpoints : 1. Sum of Pain Intensity Differences at 6 Hours (SPID0-6h) | 6 hours post-dose | score on a scale | MEAN | |
| PRIMARY | Total Pain Relief at 6 Hours (TOTPAR0-6h) | 6 hours post-dose | score on a scale | MEAN | |
| PRIMARY | Proportion of Responder Patients | 6 hours post-dose | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | The Patient's Global Impression of Change (PGIC) Questionnaire | 6 hours post-dose | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | The Onset of Pain Relief | during the first 6 hours | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 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 | score on a scale | MEAN | |
| SECONDARY | 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 | score on a scale | MEAN | |
| SECONDARY | The Pain Intensity Differences (PID) Assessment | At each timepoint: 30min, At 45min, until at 360 min post-dose | units on a scale | MEAN | |
| SECONDARY | Proportion of Responder Patients. | At 1 hour, 2 hours, 3 hours and 4 hours. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to the Second Investigational Medicinal Product (IMP) Intake | Up to 5 days after first dose | minutes | MEDIAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group138
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ranked Endpoints : 1. Sum of Pain Intensity Differences at 6 Hours (SPID0-6h) | Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | 8955.4 | Standard Deviation 8751.8 | score on a scale | |
| Ranked Endpoints : 1. Sum of Pain Intensity Differences at 6 Hours (SPID0-6h) | Paracetamol 500 mg (X2) | 8458.0 | Standard Deviation 8831.7 | score on a scale | |
| Ranked Endpoints : 1. Sum of Pain Intensity Differences at 6 Hours (SPID0-6h) | Nefopam Hydrochloride 30 mg (X2) | 5290.7 | Standard Deviation 9109.3 | score on a scale | |
| Total Pain Relief at 6 Hours (TOTPAR0-6h) | Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | 610.6 | Standard Deviation 434.5 | score on a scale | |
| Total Pain Relief at 6 Hours (TOTPAR0-6h) | Paracetamol 500 mg (X2) | 602.2 | Standard Deviation 383.6 | score on a scale | |
| Total Pain Relief at 6 Hours (TOTPAR0-6h) | Nefopam Hydrochloride 30 mg (X2) | 461.4 | Standard Deviation 384.5 | score on a scale | |
| Proportion of Responder Patients | FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | 47 | Participants | ||
| Proportion of Responder Patients | Paracetamol 500 mg (X2) | 43 | Participants | ||
| Proportion of Responder Patients | Nefopam Hydrochloride 30 mg (X2) | 35 | Participants | ||
| The Patient's Global Impression of Change (PGIC) Questionnaire | FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | VERY MUCH IMPROVED | 11 | Participants |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | 107 | |
| Overall Study | STARTED | Paracetamol 500 mg (X2) | 108 | |
| Overall Study | STARTED | Nefopam Hydrochloride 30 mg (X2) | 106 | |
| Overall Study | COMPLETED | FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | 105 | |
| Overall Study | COMPLETED | Paracetamol 500 mg (X2) | 106 | |
| Overall Study | COMPLETED | Nefopam Hydrochloride 30 mg (X2) | 104 | |
| Overall Study | NOT COMPLETED | FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | 2 | |
| Overall Study | NOT COMPLETED | Paracetamol 500 mg (X2) | 2 | |
| Overall Study | NOT COMPLETED | Nefopam Hydrochloride 30 mg (X2) | 2 |
Source ClinicalTrials.gov
Adverse events198
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | LYMPHADENOPATHY | Blood and lymphatic system disorders | FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | 0 | 107 | 0 |
| other | LYMPHADENOPATHY | Blood and lymphatic system disorders | Paracetamol 500 mg (X2) | 0 | 108 | 0 |
| other | LYMPHADENOPATHY | Blood and lymphatic system disorders | Nefopam Hydrochloride 30 mg (X2) | 1 | 106 | 1 |
| other | PALPITATIONS | Cardiac disorders | FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | 2 | 107 | 3 |
| other | PALPITATIONS | Cardiac disorders | Paracetamol 500 mg (X2) | 0 | 108 | 0 |
| other | PALPITATIONS | Cardiac disorders | Nefopam Hydrochloride 30 mg (X2) | 2 | 106 | 2 |
| other | TACHYCARDIA | Cardiac disorders | FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | 1 | 107 | 1 |
| other | TACHYCARDIA | Cardiac disorders | Paracetamol 500 mg (X2) | 0 | 108 | 0 |
| other | TACHYCARDIA | Cardiac disorders | Nefopam Hydrochloride 30 mg (X2) | 0 | 106 | 0 |
| other | EAR PAIN | Ear and labyrinth disorders | FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | 0 | 107 | 0 |
1 to 10 of 198Source ClinicalTrials.gov
See all 198 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | 0 | 107 |
| Total, all-cause mortality | Paracetamol 500 mg (X2) | 0 | 108 |
| Total, all-cause mortality | Nefopam Hydrochloride 30 mg (X2) | 0 | 106 |
| Total, other adverse events | FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | 39 | 107 |
| Total, other adverse events | Paracetamol 500 mg (X2) | 25 | 108 |
| Total, other adverse events | Nefopam Hydrochloride 30 mg (X2) | 35 | 106 |
| Total, serious adverse events | FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2) | 0 | 107 |
| Total, serious adverse events | Paracetamol 500 mg (X2) | 0 | 108 |
| Total, serious adverse events | Nefopam Hydrochloride 30 mg (X2) | 0 | 106 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT04622735/results?page=2