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Peripheral Histamine 1 Receptor Blockade in IBS: Multicenter Trial

Primary Purpose

Irritable Bowel Syndrome (IBS)

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ebastine
Placebo
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome (IBS)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UZ Antwerpen
  • ZOL (Ziekenhuis Oost-Limburg)
  • UZ Gent
  • AZ Sint-Elizabeth Zottegem
  • UZ Leuven
  • AZ Sint-Lucas Brugge
  • Rijnstate
  • Medisch Spectrum Twente
  • AZ Maastricht
  • Sint Lucas Andreas Ziekenhuis
  • Academisch Medisch Centrum
  • Tergooiziekenuizen Blaricum/Hilversum

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ebastine

placebo

Arm Description

Ebastine

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Effect of treatment on stool consistency and frequency and other common IBS associated complaints (flatulence, urgency,...)
By mean of weekly questionnaires

Full Information

First Posted
July 19, 2013
Last Updated
February 7, 2023
Sponsor
KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01908465
Brief Title
Peripheral Histamine 1 Receptor Blockade in IBS: Multicenter Trial
Official Title
Peripheral Histamine 1 Receptor Blockade in IBS
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2, 2022 (Actual)
Study Completion Date
November 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome (IBS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ebastine
Arm Type
Active Comparator
Arm Description
Ebastine
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Ebastine
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Effect of treatment on global symptom relief (of IBS complaints)
Description
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
Time Frame
after 12 weeks treatment
Secondary Outcome Measure Information:
Title
Effect of treatment on stool consistency and frequency and other common IBS associated complaints (flatulence, urgency,...)
Description
By mean of weekly questionnaires
Time Frame
fter 12 weeks treatment
Other Pre-specified Outcome Measures:
Title
Effect of treatment on quality of life
Description
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)
Time Frame
after 12 weeks treatment
Title
Effect of treatment on inflammatory mediators/metabolites in urine
Description
By metabolic profiling in urine samples before and after treatment
Time Frame
after 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Boeckxstaens, M.D.
Organizational Affiliation
Catholic University Leuven and Universitary Hospitals Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Antwerpen
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
ZOL (Ziekenhuis Oost-Limburg)
City
Genk
State/Province
Limburg
ZIP/Postal Code
3600
Country
Belgium
Facility Name
UZ Gent
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Sint-Elizabeth Zottegem
City
Zottegem
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9620
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Sint-Lucas Brugge
City
Brugge
State/Province
West-Vlaanderen
ZIP/Postal Code
8310
Country
Belgium
Facility Name
Rijnstate
City
Arnhem
State/Province
Gelderland
ZIP/Postal Code
6800
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
State/Province
Limburg
ZIP/Postal Code
7500
Country
Netherlands
Facility Name
AZ Maastricht
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6202
Country
Netherlands
Facility Name
Sint Lucas Andreas Ziekenhuis
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1061
Country
Netherlands
Facility Name
Academisch Medisch Centrum
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105
Country
Netherlands
Facility Name
Tergooiziekenuizen Blaricum/Hilversum
City
Blaricum
State/Province
Noord-Holland
ZIP/Postal Code
1213/1261
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

Peripheral Histamine 1 Receptor Blockade in IBS: Multicenter Trial

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