CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 321 enrolled
Drug / intervention
nefopam hydrochloride 30mg / paracetamol 500mg X2 +2 morecombination
Likely dose
nefopam hydrochloride 30mg / paracetamol 500mg X2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04622735
NCT04622735Phase 3Completed
CompareCT.gov

A Comparative, Randomized, Double-blind, 3-arm Parallel, Phase III Study to Evaluate the Efficacy and Safety of a Fixed Dose Combination of Nefopam/Paracetamol Taken Orally in Moderate to Severe Pain After Impacted Third Molar Extraction

Unither Pharmaceuticals, France·interventional·Posted Nov 10, 2020·Updated Nov 27, 2024

In Brief

A Phase 3 clinical trial evaluating nefopam hydrochloride 30mg / paracetamol 500mg X2, Paracetamol 500 Mg Oral Tablet X2, and 1 other intervention for Acute Pain. Completed, enrolled 321 participants across 19 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Pain
CountriesBelgium, France, Hungary, Russia, United Kingdom
CollaboratorsExcelya

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedNov 10, 2020
Enrollment StartFeb 22, 2020
Primary CompletionOct 12, 2022
Study CompletionOct 20, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 5.6 years ago

Interventions

nefopam hydrochloride 30mg / paracetamol 500mg X2combination

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.

Paracetamol 500 Mg Oral Tablet X2drug

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.

Nefopam HCl 30 MG Oral Tablet X2drug

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.