Trial | NCT04622735  Report issue

Title

Nefopam/Paracetamol Fixed Dose Combination in Acute Pain After Impacted Third Molar Extraction
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 Taken Orally in Moderate to Severe Pain After Impacted Third Molar Extraction

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    321
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.
Study Started
Feb 22
2020
Primary Completion
Oct 12
2022
Study Completion
Oct 20
2022
Last Update
Nov 14
2022

Combination Product nefopam hydrochloride 30mg / paracetamol 500mg X2 [nefopam (Acupan), acetaminophen (tylenol)]

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.

  • Other names: Acetaminophen

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.

FDC nefopam hydrochloride 30 mg / paracetamol 500 mg (X2) Experimental

Each dose: 2 tablets (included in masking capsule)

Paracetamol 500 mg (X2) Active Comparator

Each dose: 2 tablets (included in masking capsule)

Nefopam hydrochloride 30 mg (X2) Active Comparator

Each dose: 2 tablets (included in masking capsule)

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):

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)

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),
No Results Posted