NCT01908465

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2013

Longer than P75 for phase_4

Geographic Reach
2 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

9 years

First QC Date

July 19, 2013

Last Update Submit

February 7, 2023

Conditions

Irritable Bowel Syndrome (IBS)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Effect of treatment on stool consistency and frequency and other common IBS associated complaints (flatulence, urgency,...)

    fter 12 weeks treatment

Other Outcomes (2)

  • Effect of treatment on quality of life

    after 12 weeks treatment

  • Effect of treatment on inflammatory mediators/metabolites in urine

    after 12 weeks

Study Arms (2)

Ebastine

ACTIVE COMPARATOR

Ebastine

Drug: Ebastine

placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

EbastineDRUG
Ebastine
PlaceboDRUG
placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Irritable Bowel Syndrome (IBS) (ROME III criteria): subtype with diarrhea or mixed form
  • age 18-65 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

UZ Antwerpen

Edegem, Antwerpen, 2650, Belgium

Location

ZOL (Ziekenhuis Oost-Limburg)

Genk, Limburg, 3600, Belgium

Location

UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

AZ Sint-Elizabeth Zottegem

Zottegem, Oost-Vlaanderen, 9620, Belgium

Location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

AZ Sint-Lucas Brugge

Bruges, West-Vlaanderen, 8310, Belgium

Location

Rijnstate

Arnhem, Gelderland, 6800, Netherlands

Location

Medisch Spectrum Twente

Enschede, Limburg, 7500, Netherlands

Location

AZ Maastricht

Maastricht, Limburg, 6202, Netherlands

Location

Sint Lucas Andreas Ziekenhuis

Amsterdam, North Holland, 1061, Netherlands

Location

Academisch Medisch Centrum

Amsterdam, North Holland, 1105, Netherlands

Location

Tergooiziekenuizen Blaricum/Hilversum

Blaricum, North Holland, 1213/1261, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 38191268DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

ebastine

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Guy Boeckxstaens, M.D.

    Catholic University Leuven and Universitary Hospitals Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

July 19, 2013

First Posted

July 25, 2013

Study Start

November 1, 2013

Primary Completion

November 2, 2022

Study Completion

November 2, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

BE(6)NL(6)