Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT04217733
Eligibility Criteria:
Inclusion Criteria:
* • Age ≥ 18 years,
* Man and Women, Negative pregnancy test and effective contraception,
* IBS defined by the Rome criteria IV
* During the previous seven days the inclusion visit, average numeric rating scale (NRS) pain ≥ 4.
* IBS Treatment stable for 1 month
Exclusion Criteria:
* • Breastfeeding
* Diabetic patients
* Significant liver function abnormalities (transaminases\> 3N, cholestasis) and moderate renal disease (MDRD \<60 ml / min)
* Addiction to alcohol and / or drugs,
* Antiepileptic drugs taken (epilepsy or chronic pain)
* Chronic pain of greater intensity than that related to IBS,
* Known Allergyto succinimides (ethosuximide, methsuximide, phensuximide) and pentoxifylline.
* History or current severe depression (hospitalization, long-term antidepressant treatment)
* Psychotic disorders,
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04217733
Study Brief:
Protocol Section:
NCT04217733