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OpenTrials
Completed

NCT Number: NCT01144832

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

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ebastine

Drug

20 milligram capsule once daily

Placebo capsule

Drug

one capsule once daily

Primary outcomes

  1. Effect of treatment on visceral sensitivity measured with rectal barostat.

    Time frame: after 12 weeks treatment

Secondary outcomes

  1. Effect of treatment on IBS symptoms.

    Time frame: after 12 weeks treatment

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

IBS Treatment With H1-receptor Antagonists

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 16, 2010
Registry last updated
Jan 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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