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

Unither Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Acute Pain

Treatments: Drug: Nefopam HCl 30 MG Oral Tablet X2; Drug: Paracetamol 500 Mg Oral Tablet X2; Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04622735

UP-CLI-2019-002

Details and patient eligibility

About

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.

Enrollment: 321 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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),

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

321 participants in 3 patient groups

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

Experimental group

Description:

Each dose: 2 tablets (included in masking capsule)

Treatment:

Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2

Paracetamol 500 mg (X2)

Active Comparator group

Description:

Each dose: 2 tablets (included in masking capsule)

Treatment:

Drug: Paracetamol 500 Mg Oral Tablet X2

Nefopam hydrochloride 30 mg (X2)

Active Comparator group

Description:

Each dose: 2 tablets (included in masking capsule)

Treatment:

Drug: Nefopam HCl 30 MG Oral Tablet X2