Irritable Bowel Syndrome (IBS) Treatment With H1-receptor Antagonists
To evaluate the efficiency of Irritable Bowel Syndrome (IBS) patients treatment with the H1-receptor antagonist ebastine.
Double blind randomized placebo controlled trial. IBS patients receive a 12-weeks treatment with ebastine 20mg once daily or placebo (1:1 randomization).
End point is the effect of treatment on clinical symptoms and visceral hypersensitivity which will be evaluated with a barostat test.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||IBS Treatment With H1-receptor Antagonists|
- Effect of treatment on visceral sensitivity measured with rectal barostat. [ Time Frame: after 12 weeks treatment ] [ Designated as safety issue: No ]
- Effect of treatment on IBS symptoms. [ Time Frame: after 12 weeks treatment ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
|Placebo Comparator: placebo capsule||
Drug: placebo capsule
one capsule once daily
|Active Comparator: ebastine||
20 milligram capsule once daily
Please refer to this study by its ClinicalTrials.gov identifier: NCT01144832
|University hospitals Leuven|
|Leuven, Vlaams-Brabant, Belgium, 3000|
|Principal Investigator:||Guy Boeckxstaens, M.D.||Catholic University Leuven|