RecruitingPhase 3NCT05815602

Ebastine Versus Mebeverine in IBS Patients

Multicenter Randomized Controlled Clinical Trial Comparing Ebastine and Mebeverine as Treatment of Irritable Bowel Syndrome


Sponsor

Guy Boeckxstaens

Enrollment

200 participants

Start Date

Mar 30, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Duspatalin and a drug called Ebastine for people with ibs and ibs - irritable bowel syndrome. The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEbastine

Randomized subjects will administer 4 pills of study medication per day during 12 weeks. Daily administration schedule consists of taking 2 pills in the morning (1 verum, and 1 placebo). In the evening, subjects will take a second dose of both verum and placebo.

DRUGDuspatalin

Randomized subjects will administer 4 pills of study medication per day during 12 weeks. Daily administration schedule consists of taking 2 pills in the morning (1 verum, and 1 placebo). In the evening, subjects will take a second dose of both verum and placebo.


Locations(5)

GZA

Antwerp, Antwerpen, Belgium

UZA

Antwerp, Antwerpen, Belgium

AZ St-Maarten

Mechelen, Antwerpen, Belgium

UZLeuven

Leuven, Vlaams-Brabant, Belgium

AZ St-Lucas

Bruges, West-Vlaanderen, Belgium

View Full Details on ClinicalTrials.gov

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NCT05815602


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