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

May 28, 2010
May 21, 2012
October 2009
May 2012   (final data collection date for primary outcome measure)
Effect of treatment on visceral sensitivity measured with rectal barostat. [ Time Frame: after 12 weeks treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01144832 on ClinicalTrials.gov Archive Site
Effect of treatment on IBS symptoms. [ Time Frame: after 12 weeks treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Irritable Bowel Syndrome (IBS) Treatment With H1-receptor Antagonists
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Irritable Bowel Syndrome
  • Drug: ebastine
    20 milligram capsule once daily
  • Drug: placebo capsule
    one capsule once daily
  • Placebo Comparator: placebo capsule
    Intervention: Drug: placebo capsule
  • Active Comparator: ebastine
    Intervention: Drug: ebastine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01144832
S51638
No
Guy Boeckxstaens, Katholieke Universiteit Leuven
Katholieke Universiteit Leuven
Not Provided
Principal Investigator: Guy Boeckxstaens, M.D. Catholic University Leuven
Katholieke Universiteit Leuven
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP