Irritable Bowel Syndrome (IBS) Treatment With H1-receptor Antagonists

Phase 4

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: placebo capsule; Drug: ebastine

• Registration Number: NCT01144832
• Lead Sponsor: KU Leuven

Brief Summary

Purpose:

To evaluate the efficiency of Irritable Bowel Syndrome (IBS) patients treatment with the H1-receptor antagonist ebastine.

Design:

Double blind randomized placebo controlled trial. IBS patients receive a 12-weeks treatment with ebastine 20mg once daily or placebo (1:1 randomization).

End points:

End point is the effect of treatment on clinical symptoms and visceral hypersensitivity which will be evaluated with a barostat test.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-05-28
• Study First Submitted QC: 2010-06-15
• Study First Posted: 2010-06-16
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-27
• Last Update Posted: 2016-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Irritable Bowel Syndrome (ROME III criteria)
• age 18-65 years

Exclusion Criteria

• medication: antidepressants or H1-receptor antagonists
• pregnancy, breast feeding
• co-morbidity: severe kidney- and/or liver disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo capsule	placebo capsule	-
ebastine	ebastine	-

Primary Outcome Measures

Name	Time	Method
Effect of treatment on visceral sensitivity measured with rectal barostat.	after 12 weeks treatment

Secondary Outcome Measures

Name	Time	Method
Effect of treatment on IBS symptoms.	after 12 weeks treatment

Trial Locations

Locations (1)

University hospitals Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium