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 (tablet) Taken Orally in Moderate to Severe Pain After Impacted Third Molar Extractio

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 321

Inclusion Criteria

1. Male and female patient aged from 18 years up to 65 years at the time of signing the informed consent,
2. 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,
3. Patient weighing > 50 kg,
4. Female patient of childbearing potential must be willing to use an efficient birth control method during the study,
5. Patient able to swallow the IMP (capsule length 19.05 mm and width 9.39 mm),
6. Patient able to understand and comply with protocol requirements and instructions, including recording of verbal rating scale (VRS) on the electronic diary (e-Diary) as required by protocol,
7. Patient covered by national healthcare insurance system or similar system, if applicable by local regulations,
8. Patient who has signed a written informed consent prior to any study-related procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 321
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. 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,
2. Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception,
3. Patient with a history of convulsive disorders,
4. Patient taking mono-amine-oxidase (MAO) inhibitors (including but not limited to selegiline, isocarboxazid, tranylcypromine, phenelzine…),
5. Patient with an abnormal cardiac condition: medically significant disorders of cardiac rate and/or rhythm,
6. Patient with known anaemia,
7. Patient with known pulmonary disease,
8. Patient with known active gastric or duodenal ulcer or a history of recurrent gastrointestinal ulcer/bleeding,
9. Patient with known glaucoma,
10. Patients with a prostatic hyperplasia or urinary retention,
11. Patient with any known hypersensitivity to nefopam, paracetamol, ibuprofen or ingredients contained in IMPs and Non-Investigational Medicinal Product (NIMP),
12. Patient with current or chronic history of liver disease, or known hepatic or biliary abnormalities,
13. Patient with a current or chronic history of severe renal impairment (glomerular filtration below 30 mL/min),
14. Patient having developed hypersensitivity reactions, including symptoms of asthma, rhinitis or urticaria after taking acetylsalicylic acid or other NSAIDs,
15. Patient with known systemic lupus erythematosus,
16. Patient with drug or alcohol abuse within 6 months before dosing with study medication,
17. Patient having participated in any clinical research study within the previous 30 days or 5 half-lives duration of the biological effect of the investigational product (whichever is longer),
18. Patient having any current dental or medical condition that could prevent safe participation in this study,
19. Unwillingness or inability to follow the procedures outlined in the protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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