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

This study has been completed.
Information provided by (Responsible Party):
Guy Boeckxstaens, Katholieke Universiteit Leuven Identifier:
First received: May 28, 2010
Last updated: January 27, 2016
Last verified: January 2016

May 28, 2010
January 27, 2016
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 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


To evaluate the efficiency of Irritable Bowel Syndrome (IBS) patients treatment with the H1-receptor antagonist ebastine.


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
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
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, Ghesquière 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Guy Boeckxstaens, Katholieke Universiteit Leuven
Katholieke Universiteit Leuven
Not Provided
Principal Investigator: Guy Boeckxstaens, M.D. Catholic University Leuven
Katholieke Universiteit Leuven
January 2016

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