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

NCT04622735 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2024-11-27

Study results available
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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

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.

Sponsors & Collaborators

  • Excelya

    collaborator INDUSTRY

  • Unither Pharmaceuticals, France

    lead INDUSTRY

Principal Investigators

  • International Study Coordinator · Birmingham School of Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-22
Primary Completion
2022-10-12
Completion
2022-10-20

Countries

  • Belgium
  • France
  • Hungary
  • Russia
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04622735 on ClinicalTrials.gov