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

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Unither Pharmaceuticals, France
• Collaborator: EXCELYA Bordeaux
• Treatments: Acetaminophen; Nefopam

Criteria

Main Inclusion Criteria:

• Male and female patient aged from 18 years up to 65 years,

• Patient scheduled to undergo the surgical removal of at least one fully or partially impacted third mandibular molar requiring bone removal under short-acting local anaesthetic (mepivacaine or lidocaine) with or without vasoconstrictor,

• Patient weighing > 50 kg,

• Patient who has signed a written informed consent prior to any study-related procedures.

Additional inclusion criteria after surgery (randomization):

1. 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,

2. 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)

Main Exclusion Criteria:

• Patient treated by analgesics or nonsteroidal anti-inflammatory drugs (NSAIDs) within 3 days preceding the day of randomization or within 5 times the elimination half-life whichever the longest,

• Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception,

• Patient with a history of convulsive disorders,

• Patient taking mono-amine-oxidase (MAO) inhibitors (including but not limited to selegiline, isocarboxazid, tranylcypromine, phenelzine…),

• Patient with an abnormal cardiac condition: medically significant disorders of cardiac rate and/or rhythm,

• Patient with known anaemia,

• Patient with known pulmonary disease,

• Patient with known active gastric or duodenal ulcer or a history of recurrent gastrointestinal ulcer/bleeding,

• Patient with known glaucoma,

• Patients with a prostatic hyperplasia or urinary retention,

• Patient with current or chronic history of liver disease, or known hepatic or biliary abnormalities,

• Patient with a current or chronic history of severe renal impairment (glomerular filtration below 30 mL/min),