CompletedPhase 3

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

Belgium, France321 participantsStarted 2020-02-22

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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,
✓. 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)

What they're measuring

Ranked Endpoints : 1. Sum of Pain Intensity Differences at 6 Hours (SPID0-6h)

Timeframe: 6 hours post-dose

Total Pain Relief at 6 Hours (TOTPAR0-6h)

Timeframe: 6 hours post-dose

Proportion of Responder Patients

Timeframe: 6 hours post-dose

The Patient's Global Impression of Change (PGIC) Questionnaire

Timeframe: 6 hours post-dose

The Onset of Pain Relief

Timeframe: during the first 6 hours

Trial details

NCT IDNCT04622735

SponsorUnither Pharmaceuticals, France

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10-12

Results submitted2024-02-29

View on ClinicalTrials.gov More Acute Pain trials