Pharmacokinetic Study of the Use of Nefopam 30 mg Tablets in Patients Suffering From Acute Pain i… (NCT07491393) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Pharmacokinetic Study of the Use of Nefopam 30 mg Tablets in Patients Suffering From Acute Pain in Rheumatology
France24 participantsStarted 2026-04-01
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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)
* 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 tubal 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,
* and having a negative urinary pregnancy test for β-HCG at inclusion.
* 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…