Irritable Bowel Syndrome (IBS) Treatment With H1-receptor Antagonists
IBS Treatment With H1-receptor Antagonists
1 other identifier
interventional
55
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2009
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 28, 2010
CompletedFirst Posted
Study publicly available on registry
June 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedJanuary 28, 2016
January 1, 2016
2.6 years
May 28, 2010
January 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of treatment on visceral sensitivity measured with rectal barostat.
after 12 weeks treatment
Secondary Outcomes (1)
Effect of treatment on IBS symptoms.
after 12 weeks treatment
Study Arms (2)
placebo capsule
PLACEBO COMPARATORebastine
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Irritable Bowel Syndrome (ROME III criteria)
- age 18-65 years
You may not qualify if:
- medication: antidepressants or H1-receptor antagonists
- pregnancy, breast feeding
- co-morbidity: severe kidney- and/or liver disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KU Leuvenlead
Study Sites (1)
University hospitals Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
Related Publications (1)
Wouters MM, Balemans D, Van Wanrooy S, Dooley J, Cibert-Goton V, Alpizar YA, Valdez-Morales EE, Nasser Y, Van Veldhoven PP, Vanbrabant W, Van der Merwe S, Mols R, Ghesquiere B, Cirillo C, Kortekaas I, Carmeliet P, Peetermans WE, Vermeire S, Rutgeerts P, Augustijns P, Hellings PW, Belmans A, Vanner S, Bulmer DC, Talavera K, Vanden Berghe P, Liston A, Boeckxstaens GE. Histamine Receptor H1-Mediated Sensitization of TRPV1 Mediates Visceral Hypersensitivity and Symptoms in Patients With Irritable Bowel Syndrome. Gastroenterology. 2016 Apr;150(4):875-87.e9. doi: 10.1053/j.gastro.2015.12.034. Epub 2016 Jan 2.
PMID: 26752109DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guy Boeckxstaens, M.D.
Catholic University Leuven
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
May 28, 2010
First Posted
June 16, 2010
Study Start
October 1, 2009
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
January 28, 2016
Record last verified: 2016-01