Symptomatic short-term treatment of moderate to severe somatic pain MedDRA version: 20.0 Level: PT Classification code 10033371 Term: Pain System Organ Class: 10018065 - General disorders and administration site conditions
Conditions
Interventions
Product Name: 30 mg nefopam hydrochloride / 500 mg paracetamol
Product Code: FDC 08P1737F0
Pharmaceutical Form: Tablet
INN or Proposed INN: NEFOPAM HYDROCHLORIDE
CAS Number: 23327-57-3
Other descript
Sponsors
UNITHER Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
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 311 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate, after one single administration, the efficacy of nefopam hydrochloride (30 mg) / paracetamol (500 mg) x2 oral Fixed Dose Combination (FDC) versus oral nefopam hydrochloride alone (30 mg) x2 and oral paracetamol alone (500 mg) x2 in patients with moderate to severe pain after impacted third mandibular molar extraction.;Secondary Objective: To assess the efficacy of nefopam hydrochloride (30 mg) / paracetamol (500 mg) x2 oral Fixed Dose Combination (FDC) versus oral nefopam hydrochloride alone (30 mg) x2 and oral paracetamol alone (500 mg) x2 after single or multiple administrations.;Primary end point(s): Sum of Pain Intensity Differences at 6 hours (SPID0-6h) following the first IMP intake.;Timepoint(s) of evaluation of this end point: PID will be calculated using the score of pain intensity assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240, T300, T360 min,) after the first IMP intake and/or right before first intake of rescue medication using a 100-mm VAS compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Total Pain Relief, - Number and proportion of responder patients, - The Patient’s Global Impression of Change (PGIC) questionnaire assessment, - The onset of pain relief, ;Timepoint(s) of evaluation of this end point: - Total Pain Relief: at 6 hours (TOTPAR0-6h) following the first IMP intake, - Number and proportion of responder patients: at 6 hours following the first IMP intake, - The Patient's Global Impression of Change (PGIC) questionnaire assessment: at 6 hours after the first IMP intake or at time of first intake of rescue medication, - The onset of pain relief: during the first 6 hours after the first IMP intake | — |
Countries
Belgium, France, Russian Federation, United Kingdom
Contacts
Public ContactNathalie MASSON
UNITHER Pharmaceuticals
Outcome results
None listed