NCT04622735

Nefopam/Paracetamol Fixed Dose Combination in Acute Pain After Impacted Third Molar Extraction

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 321 (actual)
• Sponsor: Unither Pharmaceuticals, France · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Pain

Interventions

Type	Name	Description
COMBINATION_PRODUCT	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.
DRUG	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.
DRUG	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.

Timeline

• Start date: 2020-02-22
• Primary completion: 2022-10-12
• Completion: 2022-10-20
• First posted: 2020-11-10
• Last updated: 2024-11-27
• Results posted: 2024-11-27

Locations

19 sites across 5 countries: Belgium, France, Hungary, Russia, United Kingdom