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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guy Boeckxstaens, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01144832
First received: May 28, 2010
Last updated: May 21, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome
Drug: ebastine
Drug: placebo capsule
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Effect of treatment on visceral sensitivity measured with rectal barostat. [ Time Frame: after 12 weeks treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of treatment on IBS symptoms. [ Time Frame: after 12 weeks treatment ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: October 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo capsule Drug: placebo capsule
one capsule once daily
Active Comparator: ebastine Drug: ebastine
20 milligram capsule once daily

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01144832

Locations
Belgium
University hospitals Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
Investigators
Principal Investigator: Guy Boeckxstaens, M.D. Catholic University Leuven
  More Information

No publications provided

Responsible Party: Guy Boeckxstaens, Prof. Dr., Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01144832     History of Changes
Other Study ID Numbers: S51638
Study First Received: May 28, 2010
Last Updated: May 21, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Katholieke Universiteit Leuven:
visceral hypersensitivity
mast cells

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Disease
Pathologic Processes
Ebastine
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014