Clinical Trial

Ebastine Versus Mebeverine in IBS Patients

Recruiting Phase 3
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Summary
Multicenter randomized controlled clinical trial comparing ebastine and mebeverine as treatment of irritable bowel syndrome Trial rationale 1. To perform a randomized superiority trial comparing the clinical efficacy of ebastine and mebeverine 2. To evaluate the impact of treatment with ebastine compared to mebeverine on quality of life and quality-adjusted life years Primary objective To provide further evidence of the superiority of histamine 1 receptor antagonism as novel treatment for patients with non-constipated IBS, as compared to mebeverine, one of the spasmolytics currently used as first line treatment of IBS. Secondary objective(s) To provide evidence that the histamine 1 receptor antagonist ebastine is more effective in reducing abdominal pain compared to the commonly used antispasmodic mebeverine
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-04-04; most recent amendment 2026-03-19.
Trial Details
NCT Number NCT05815602
Lead Sponsor Guy Boeckxstaens
Collaborators: Fund for Scientific Research, Flanders, Belgium
Conditions IBS - Irritable Bowel Syndrome, IBS
Enrollment 200 participants
Start Date 2023-03-30
Primary Completion 2027-10-01 (estimated)
Study Completion 2028-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-23