Ethosuximide to Treat IBS (IBSET)
Irritable Bowel Syndrome
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring IBS, Ethosuximide, Pain
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years,
- Man,
- Women, Negative pregnancy test and effective contraception,
- IBS defined by the Rome criteria IV
- During the previous seven days the inclusion visit, average NRS pain ≥ 4,
- IBS Treatment stable for 1 month
- Patients affiliated to the French Social Security,
- Patients with the informed consent were obtained.
Exclusion Criteria:
- Breastfeeding
- 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,
- AEDs taken (epilepsy or chronic pain)
- chronic pain of greater intensity than that related to IBS,
- Allergy succinimides (ethosuximide, methsuximide, phensuximide)
- History or current severe depression (hospitalization, long-term antidepressant treatment)
- Psychotic disorders,
- Patients exclusion period, or total exceeded authorized allowances
- Patients undergoing a measure of legal protection (trusteeship, guardianship ...).
Sites / Locations
- CHU Clermont-Ferrand
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
ethosuximide
placebo
A responder will correspond to a decrease in abdominal pain score (11-points NRS pain) of at least 30% compared to the score before treatment and a score of 6 or 7 on the SGA scale. At endpoint (12-weeks treatment period), it will be compared the responder rate between the 2 treatment arms (ethosuximide vs placebo).
A responder will correspond to a decrease in abdominal pain score (11-points NRS pain) of at least 30% compared to the score before treatment and a score of 6 or 7 on the SGA scale. At endpoint (12-weeks treatment period), it will be compared the responder rate between the 2 treatment arms (ethosuximide vs placebo).