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NCT01908465 Clinical Trial

Peripheral Histamine 1 Receptor Blockade in IBS: Multicenter Trial

Irritable Bowel Syndrome (IBS) Clinical Trial

Official title:
Peripheral Histamine 1 Receptor Blockade in IBS

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01908465
Other study ID # S55485
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 2013
Est. completion date November 2, 2022

Study information
Verified date February 2023
Source KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date November 2, 2022
Est. primary completion date November 2, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Irritable Bowel Syndrome (IBS) (ROME III criteria): subtype with diarrhea or mixed form - age 18-65 years Exclusion Criteria: - IBS subtype with constipation - medication: antidepressants or H1-receptor antagonists - pregnancy, breast feeding - co-morbidity: severe kidney- and/or liver disease or other gastrointestinal diseases

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ebastine

• Placebo

Locations
Country Name City State
Belgium AZ Sint-Lucas Brugge Brugge West-Vlaanderen
Belgium UZ Antwerpen Edegem Antwerpen
Belgium ZOL (Ziekenhuis Oost-Limburg) Genk Limburg
Belgium UZ Gent Gent Oost-Vlaanderen
Belgium UZ Leuven Leuven Vlaams-Brabant
Belgium AZ Sint-Elizabeth Zottegem Zottegem Oost-Vlaanderen
Netherlands Academisch Medisch Centrum Amsterdam Noord-Holland
Netherlands Sint Lucas Andreas Ziekenhuis Amsterdam Noord-Holland
Netherlands Rijnstate Arnhem Gelderland
Netherlands Tergooiziekenuizen Blaricum/Hilversum Blaricum Noord-Holland
Netherlands Medisch Spectrum Twente Enschede Limburg
Netherlands AZ Maastricht Maastricht Limburg

Sponsors (1)
Lead Sponsor Collaborator
KU Leuven

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Other Effect of treatment on quality of life By mean of 'Quality of life" questionnaire (completed at the end (after 14 weeks) and the start of the study and after 8 and 12 weeks of treatment) after 12 weeks treatment
Other Effect of treatment on inflammatory mediators/metabolites in urine By metabolic profiling in urine samples before and after treatment after 12 weeks
Primary Effect of treatment on global symptom relief (of IBS complaints) By mean of weekly GSRS (Gastrointestinal Symptom Rating Scale )questionnaires and weekly "SGA (Subject's Global Assessment) of relief" and "SGA of Abdominal Pain and Discomfort" questionnaires after 12 weeks treatment
Secondary Effect of treatment on stool consistency and frequency and other common IBS associated complaints (flatulence, urgency,...) By mean of weekly questionnaires fter 12 weeks treatment
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