NEFOPAM HYDROCHLORIDE for Acute rheumatological pain | Acute musculoskeletal pain

Inclusion criteria

• {"criterion_text":"- Hospitalized rheumatology patient\n- Patient affiliated to or benefiting from a social security scheme\n- Patients with acute musculoskeletal pain\n- Estimated remaining hospital stay ≥ 4 days\n- NS ≥ 3\n- Age ≥ 18 years and ≤ 75 years\n- Patient has read and understood the information letter and signed the consent form\n- • Women o 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) o\t\t\t\t- using highly effective contraception according to the CTCG (combined hormonal contraception (estrogen and progesterone) associated with ovulation inhibition (oral, intravaginal, transdermal), hormonal contraception (progesterone only) associated with ovulation inhibition (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral fallopian tube occlusion, vasectomized partner, sexual abstinence) for at least 4 weeks prior to inclusion, during treatment, and up to 3 days after the last dose/administration of treatment, \t\t\t- and having a negative urinary pregnancy test for β-HCG at inclusion. o Menopausal: Menopause, according to the CTCG, is defined 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."}

Exclusion criteria

• {"criterion_text":"- Patients receiving nefopam within 7 days of inclusion\n- Patient unable to understand pain scales\n- Medical contraindication to NEFOPAM VIATRIS 20 mg/2 mL, solution for injection or NEFOPAM PANPHARMA 30 mg, film-coated tablet: o Hypersensitivity to nefopam or any of its excipients. o Convulsions or history of convulsive disorders. o Risk of urinary retention due to urethroprostatic disorders. o Risk of angle-closure glaucoma.\n- Patient suffering from constipation\n- Patient with a history of substance use disorders\n- Pregnant, parturient or breast-feeding women, or those without proven contraception\n- Person deprived of liberty by an administrative or judicial decision or person placed under safeguard of justice / sub-guardianship or curatorship\n- Patients with creatinine clearance ≤ 30 ml/min according to the CKD-EPI formula\n- Patient treated with drug(s) containing alcohol as excipient\n- Severe or uncontrolled cardiovascular disease.\n- Patients treated with an enzyme inducer or inhibitor (Amiodarone, Bupropion, Fluoxetine, Paroxetine, Quinidine, Venlafaxine, Haloperidol, Imipramine, Tamoxifen, Ketoconazole, Ritonavir, Clarithromycin, Carbamazepine, St. John's Wort, Itraconazole, Rifampicin, Dexamethasone)\n- Patients with severe hepatic impairment (ASAT and/or ALAT > 5 times the upper normal)\n- History of psychological or sensory illness or abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or from giving informed consent"}

Primary endpoints

• {"endpoint_text":"- main PK parameters will be determined using PKAnalix 2024R1 software (MonolixSuite, Saclay, France). They will include terminal elimination half-life, maximum concentration (Cmax), time at maximum concentration (Tmax) and exposure, characterized by the area under the curve obtained using the trapezoidal method. Bbioavailability will be calculated as the ratio of the AUC between the oral and intravenous forms, normalized to the dose for each patient using the cross-over design","definition_or_measurement_approach":"Primary PK parameters determined using PKAnalix 2024R1 (MonolixSuite). Parameters include terminal elimination half-life, Cmax, Tmax and AUC (exposure) calculated using the trapezoidal method. Bioavailability calculated as AUC ratio oral/IV normalized to dose in cross-over design."}

Secondary endpoints

• {"endpoint_text":"- volume of distribution (Vd), maximum plasma concentration of the PO form (Cmax), time after intake for which the concentration is maximum (Tmax), terminal elimination half-life and bioavailability, and to highlight potential clinico-biological factors responsible for a variation in exposure. The flexibility of the modeling will then enable different doses to be simulated to determine the optimal dosages maximizing likelihood with the IV route.","definition_or_measurement_approach":"Secondary endpoints include Vd, Cmax (PO), Tmax, terminal half-life and bioavailability; analyses aim to identify clinico-biological covariates explaining exposure variability and to use population modelling to simulate doses for optimal IV dosing."}

France

Earliest CTIS Part Ii Submission Date

08-08-2025

Latest Decision Or Authorization Date

20-01-2026

Processing Time Days

165

Number Of Sites

1

Number Of Participants

29

Primary sponsor

Full Name

Centre Hospitalier Universitaire Rouen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France