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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: January 27, 2016
Last verified: January 2016
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: IBS Treatment With H1-receptor Antagonists

Further study details as provided by Guy Boeckxstaens, Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Effect of treatment on visceral sensitivity measured with rectal barostat. [ Time Frame: after 12 weeks treatment ]

Secondary Outcome Measures:
  • Effect of treatment on IBS symptoms. [ Time Frame: after 12 weeks treatment ]

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   (Adult)
Sexes Eligible for Study:   All
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: January 27, 2016

Keywords provided by Guy Boeckxstaens, Katholieke Universiteit Leuven:
visceral hypersensitivity
mast cells

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

ClinicalTrials.gov processed this record on September 21, 2017