Peripheral Histamine 1 Receptor Blockade in IBS: Multicenter Trial

Phase 4

Completed

• Conditions: Irritable Bowel Syndrome (IBS)
• Interventions: Drug: Placebo; Drug: Ebastine

• Registration Number: NCT01908465
• Lead Sponsor: KU Leuven

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-19
• Study First Submitted QC: 2013-07-23
• Study First Posted: 2013-07-25
• Study Start: 2013-11
• Primary Completion: 2022-11-02
• Study Completion: 2022-11-02
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	Placebo
Ebastine	Ebastine	Ebastine

Primary Outcome Measures

Name	Time	Method
Effect of treatment on global symptom relief (of IBS complaints)	after 12 weeks treatment	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

Secondary Outcome Measures

Name	Time	Method
Effect of treatment on stool consistency and frequency and other common IBS associated complaints (flatulence, urgency,...)	fter 12 weeks treatment	By mean of weekly questionnaires

Trial Locations

Locations (12)

ZOL (Ziekenhuis Oost-Limburg); 🇧🇪 Genk, Limburg, Belgium

Academisch Medisch Centrum; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Rijnstate; 🇳🇱 Arnhem, Gelderland, Netherlands

UZ Antwerpen; 🇧🇪 Edegem, Antwerpen, Belgium

UZ Gent; 🇧🇪 Gent, Oost-Vlaanderen, Belgium

AZ Sint-Lucas Brugge; 🇧🇪 Brugge, West-Vlaanderen, Belgium

AZ Sint-Elizabeth Zottegem; 🇧🇪 Zottegem, Oost-Vlaanderen, Belgium

UZ Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium

Medisch Spectrum Twente; 🇳🇱 Enschede, Limburg, Netherlands

AZ Maastricht; 🇳🇱 Maastricht, Limburg, Netherlands

Sint Lucas Andreas Ziekenhuis; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Tergooiziekenuizen Blaricum/Hilversum; 🇳🇱 Blaricum, Noord-Holland, Netherlands