EUCTR2016-002110-42-FR进行中(未招募)1 期
Evaluation of the effectiveness and safety of ethosuximide in the treatment of abdominal pain associated with irritable bowel syndrome - IBSET
CHU CLERMONT-FERRAND0 个研究点目标入组 286 人开始时间: 2019年5月28日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 286
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •-Age = 18 years,
- •-Women, negative pregnancy test and effective contraception,
- •-SII defined by the Rome IV
- •-During the seven days preceding the inclusion visit, NRS discomfort / pain average = 4,
- •-Treatment for IBS stable for 1 month,
- •-Patients affiliated to the regime of the French Social Security,
- •-Patients with the free and informed consent was obtained.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 286
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •breastfeeding
- •Chronic pain condition equal or greater in severity than the pain related to IBS
- •diabetic patients
- •known renal or hepatic impairment
- •significant liver function abnormalities (transaminases> 3N, cholestasis) and renal (MDRD <60 ml / min)
- •Addiction to alcohol and / or drugs
- •Taking antiepileptic family carboxamides, and ethosuximide
- •Allergy succinimides (ethosuximide, methsuximide, phensuximide)
- •severe depression or current history (hospitalization, antidepressants long term)
- •psychotic disorders
- •Antiepileptic drugs
- •Patients exclusion period, or total compensation exceeded permitted
- •Patients undergoing a measure of legal protection (trusteeship, guardianship ...).
研究者
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