New study looks at how painkiller works in rheumatic pain
NCT ID NCT07491393
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study will examine how the painkiller nefopam works in 24 adults hospitalized with acute rheumatic pain. Researchers will measure how the drug is processed in the body, including its peak levels and how long it stays active. The goal is to better understand the drug's effects, not to test a new treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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: * Hypersensitivity to nefopam or any of the excipients. * Convulsions or history of convulsive disorders. * Risk of urinary retention associated with urethroprostatic disorders. * Risk of angle-closure glaucoma. * 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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU de ROUEN
Rouen, France