Peripheral Histamine 1 Receptor Blockade in IBS: Multicenter Trial
NCT ID: NCT01908465
Last Updated: 2023-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2013-11-30
2022-11-02
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ebastine
Ebastine
Ebastine
placebo
Placebo
Placebo
Interventions
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Ebastine
Placebo
Eligibility Criteria
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Inclusion Criteria
* age 18-65 years
Exclusion Criteria
* medication: antidepressants or H1-receptor antagonists
* pregnancy, breast feeding
* co-morbidity: severe kidney- and/or liver disease or other gastrointestinal diseases
18 Years
65 Years
ALL
No
Sponsors
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KU Leuven
OTHER
Responsible Party
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Guy Boeckxstaens
Prof. Dr.
Principal Investigators
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Guy Boeckxstaens, M.D.
Role: PRINCIPAL_INVESTIGATOR
Catholic University Leuven and Universitary Hospitals Leuven
Locations
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UZ Antwerpen
Edegem, Antwerpen, Belgium
ZOL (Ziekenhuis Oost-Limburg)
Genk, Limburg, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, Belgium
AZ Sint-Elizabeth Zottegem
Zottegem, Oost-Vlaanderen, Belgium
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
AZ Sint-Lucas Brugge
Bruges, West-Vlaanderen, Belgium
Rijnstate
Arnhem, Gelderland, Netherlands
Medisch Spectrum Twente
Enschede, Limburg, Netherlands
AZ Maastricht
Maastricht, Limburg, Netherlands
Sint Lucas Andreas Ziekenhuis
Amsterdam, North Holland, Netherlands
Academisch Medisch Centrum
Amsterdam, North Holland, Netherlands
Tergooiziekenuizen Blaricum/Hilversum
Blaricum, North Holland, Netherlands
Countries
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References
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Decraecker L, De Looze D, Hirsch DP, De Schepper H, Arts J, Caenepeel P, Bredenoord AJ, Kolkman J, Bellens K, Van Beek K, Pia F, Peetermans W, Vanuytsel T, Denadai-Souza A, Belmans A, Boeckxstaens G. Treatment of non-constipated irritable bowel syndrome with the histamine 1 receptor antagonist ebastine: a randomised, double-blind, placebo-controlled trial. Gut. 2024 Feb 23;73(3):459-469. doi: 10.1136/gutjnl-2023-331634.
Other Identifiers
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S55485
Identifier Type: -
Identifier Source: org_study_id
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