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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521926-13-00 | EU Trial (CTIS) Number |
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Nefopam is a non-opioid analgesic approved for the symptomatic treatment of acute pain, particularly postoperative pain. The HAS has authorized nefopam tablet, while emphasizing the lack of bibliographic data on both the pharmacokinetic and clinical aspects.
The aim of this study is to evaluate the pharmacokinetics of nefopam tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 : IV then tablet form | Other | administration of Nefopam IV (H0) - washout (H0 Ã H72) -nefopam tablet administration (H72) |
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| Sequence 2 : tablet then IV form | Other | administration of Nefopam tablet administration (H0) - washout (H0 Ã H72) -nefopam IV administration (H72) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nefopam administration and prelevment | Drug | Catheter placement, blood samples taken from H0 to H12 after each dose of nefopam in 4mL lithium heparin tubes without separating gel (9 samples per dose of nefopam) |
| Measure | Description | Time Frame |
|---|---|---|
| terminal elimination half-life | terminal elimination half-life | 6 days |
| Cmax | Peak plasma concentration | 6 days |
| Tmax | time to maximum concentration | 6 days |
| exposure | characterized by the area under the curve obtained using the trapezoidal method | 6 days |
| bioavailability | bioavailability will be calculated using the ratio of AUCs between the oral and intravenous forms | 6 days |
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Inclusion Criteria:
Patient hospitalized in rheumatology,
Patient presenting with acute pain in the musculoskeletal system,
Expected remaining length of hospital stay ≥ 4 days,
EN ≥ 3
Age ≥ 18 and ≤ 75,
Patient who has read and understood the information letter and signed the consent form
Women:
Of childbearing age, defined by the CTCG as fertile women, after menarche and until menopause, except in cases of permanent infertility (including hysterectomy, bilateral salpingectomy, or bilateral oophorectomy)
Postmenopausal: Menopause is defined by the CTCG as the absence of menstruation for 12 months without any other medical cause. Elevated follicle-stimulating hormone (FSH) levels in the postmenopausal interval can be used to confirm postmenopausal status in women who are not using hormonal contraception or hormone replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
Patient affiliated with a social security system or beneficiary of such a system.
Exclusion Criteria:
Patients who have received nefopam within 7 days prior to inclusion
Patients with creatinine clearance ≤ 30 mL/min according to the CKD-EPI formula
Severe or uncontrolled cardiovascular disease. Patients treated with enzyme-inducing or enzyme-inhibiting drugs (amiodarone, bupropion, fluoxetine, paroxetine, quinidine, venlafaxine, haloperidol, imipramine, tamoxifen, ketoconazole, ritonavir, clarithromycin, Carbamazepine, St. John's Wort, Itraconazole, Rifampicin, Dexamethasone)
Patients treated with medication(s) containing alcohol as an excipient.
Patients with severe hepatic impairment (ASAT and/or ALAT > 5 times the upper normal limit).
History of psychological or sensory disease or abnormality that may prevent the subject from fully understanding the conditions required for participation in the protocol or prevent them from giving informed consent.
Patients unable to understand pain scales.
Medical contraindications for NEFOPAM VIATRIS 20 mg/2 mL, injectable solution, or NEFOPAM PANPHARMA 30 mg, film-coated tablet:
Patients suffering from constipation.
Patients with a history of disorders associated with the use of psychoactive substances.
Pregnant women, women in labor, breastfeeding women, or women who are not using effective contraception.
Persons deprived of their liberty by administrative or judicial decision or persons placed under judicial protection/guardianship or curatorship
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophie Pouplin, MD | Contact | +332 32 88 92 21 | sophie.pouplin@chu-rouen.fr | |
| Armelle Guidotti | Contact | armelle.guidotti@chu-rouen.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de ROUEN | Rouen | France |
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