NCT07491393尚未招募4 期
Pharmacokinetic Study of the Use of Nefopam 30 mg Tablets in Patients Suffering From Acute Pain in Rheumatology
University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年4月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- terminal elimination half-life
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient hospitalized in rheumatology,
- •Patient presenting with acute pain in the musculoskeletal system,
- •Expected remaining length of hospital stay ≥ 4 days,
- •Age ≥ 18 and ≤ 75,
- •Patient who has read and understood the information letter and signed the consent form
- •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.
排除标准
- •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
结局指标
主要结局
terminal elimination half-life
时间窗: 6 days
terminal elimination half-life
Cmax
时间窗: 6 days
Peak plasma concentration
Tmax
时间窗: 6 days
time to maximum concentration
exposure
时间窗: 6 days
characterized by the area under the curve obtained using the trapezoidal method
bioavailability
时间窗: 6 days
bioavailability will be calculated using the ratio of AUCs between the oral and intravenous forms
次要结局
未报告次要终点
研究者
研究点 (1)
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