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RECRUITING
NCT05815602
PHASE3

Ebastine Versus Mebeverine in IBS Patients

Sponsor: Guy Boeckxstaens

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2023-03-30

Completion Date

2028-01-01

Last Updated

2026-03-23

Healthy Volunteers

No

Interventions

DRUG

Ebastine

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.

DRUG

Duspatalin

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