Effectiveness of ethosuximide in the treatment of irritable bowel syndrome
- Conditions
- abdominal pain related to irritable bowel syndromeTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2016-002110-42-FR
- Lead Sponsor
- CHU CLERMONT-FERRAND
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 286
-Age = 18 years,
-Man,
-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
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 ...).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method