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Ebastine Versus Mebeverine in IBS Patients
Sponsor: Guy Boeckxstaens
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
Conditions
Interventions
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.
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