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

IBS Treatment With H1-receptor Antagonists

Sponsors

Lead Sponsor: KU Leuven

Source 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.

Overall Status Completed
Start Date October 2009
Completion Date May 2012
Primary Completion Date May 2012
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Effect of treatment on visceral sensitivity measured with rectal barostat. after 12 weeks treatment
Secondary Outcome
Measure Time Frame
Effect of treatment on IBS symptoms. after 12 weeks treatment
Enrollment 55
Condition
Intervention

Intervention Type: Drug

Intervention Name: ebastine

Description: 20 milligram capsule once daily

Arm Group Label: ebastine

Intervention Type: Drug

Intervention Name: placebo capsule

Description: one capsule once daily

Arm Group Label: placebo capsule

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Guy Boeckxstaens, M.D. Principal Investigator Catholic University Leuven
Location
Facility: University hospitals Leuven
Location Countries

Belgium

Verification Date

January 2016

Responsible Party

Type: Principal Investigator

Investigator Affiliation: KU Leuven

Investigator Full Name: Guy Boeckxstaens

Investigator Title: Prof. Dr.

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: placebo capsule

Type: Placebo Comparator

Label: ebastine

Type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov