CompletedPhase 3

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

Belgium, France, Hungary321 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 range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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