Irritable Bowel Syndrome (IBS) Treatment With H1-receptor Antagonists
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|ClinicalTrials.gov Identifier: NCT01144832|
Recruitment Status : Completed
First Posted : June 16, 2010
Last Update Posted : January 28, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome||Drug: ebastine Drug: placebo capsule||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||IBS Treatment With H1-receptor Antagonists|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
|Placebo Comparator: placebo capsule||
Drug: placebo capsule
one capsule once daily
|Active Comparator: ebastine||
20 milligram capsule once daily
- Effect of treatment on visceral sensitivity measured with rectal barostat. [ Time Frame: after 12 weeks treatment ]
- Effect of treatment on IBS symptoms. [ Time Frame: after 12 weeks treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144832
|University hospitals Leuven|
|Leuven, Vlaams-Brabant, Belgium, 3000|
|Principal Investigator:||Guy Boeckxstaens, M.D.||Catholic University Leuven|