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临床试验/EUCTR2016-002110-42-FR
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

发起方
CHU CLERMONT-FERRAND

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