METAPAIN (version 2.0)
Research type
Research Study
Full title
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 (tablet) Taken Orally in Moderate to Severe Pain After Impacted Third Molar Extraction.
IRAS ID
288863
Contact name
Thomas Dietrich
Contact email
Sponsor organisation
UNITHER Pharmaceuticals
Eudract number
2020-002245-42
Duration of Study in the UK
0 years, 8 months, 31 days
Research summary
The purpose of this study is to assess the efficacy and safety of a new fixed drug combination (FDC) (nefopam hydrochloride 30mg / paracetamol 500mg) called analgesics, commonly known as pain killers or pain relievers in patients with a moderate to severe pain after a wisdom tooth extraction.
Lay summary of study results: This study tested for the first time the oral combination of nefopam and paracetamol. The purpose was to demonstrate the superior-ity of the oral combination of two analgesics, paracetamol and nefopam, over each of the single components, in a post-operative model. Although the superiority of the combination was not clearly demonstrated over paracetamol, a significant improvement in pain intensity and pain relief was observed between the combina-tion and the nefopam alone. The safety profile of the FDC was comparable to the respective individual active substance.
REC name
London - Riverside Research Ethics Committee
REC reference
20/LO/1301
Date of REC Opinion
21 Jan 2021
REC opinion
Further Information Favourable Opinion