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Peripheral Histamine 1 Receptor Blockade in IBS: Multicenter Trial

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ClinicalTrials.gov Identifier: NCT01908465
Recruitment Status : Unknown
Verified February 2017 by Guy Boeckxstaens, KU Leuven.
Recruitment status was:  Recruiting
First Posted : July 25, 2013
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Guy Boeckxstaens, 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).


Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome (IBS) Drug: Ebastine Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Peripheral Histamine 1 Receptor Blockade in IBS
Study Start Date : November 2013
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Histamine

Arm Intervention/treatment
Active Comparator: Ebastine
Ebastine
Drug: Ebastine
Placebo Comparator: placebo
Placebo
Drug: Placebo



Primary Outcome Measures :
  1. Effect of treatment on global symptom relief (of IBS complaints) [ Time Frame: 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 :
  1. Effect of treatment on stool consistency and frequency and other common IBS associated complaints (flatulence, urgency,...) [ Time Frame: fter 12 weeks treatment ]
    By mean of weekly questionnaires


Other Outcome Measures:
  1. Effect of treatment on quality of life [ Time Frame: after 12 weeks treatment ]
    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)

  2. Effect of treatment on inflammatory mediators/metabolites in urine [ Time Frame: after 12 weeks ]
    By metabolic profiling in urine samples before and after treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908465


Contacts
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Contact: Lien Beullens, MSc 0032-16-341943 lien.beullens@kuleuven.be
Contact: Dafne Balemans, MSc 0032-16-330158 dafne.balemans@med.kuleuven.be

Locations
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Belgium
UZ Antwerpen Not yet recruiting
Edegem, Antwerpen, Belgium, 2650
Contact: Tom Moreels, M.D.    +32 3 821 33 24    tom.moreels@uza.be   
Sub-Investigator: Tom Moreels, M.D.         
ZOL (Ziekenhuis Oost-Limburg) Recruiting
Genk, Limburg, Belgium, 3600
Contact: Philip Caenepeel, M.D.    +32 8 32 65 13    philip.caenepeel@zol.be   
Sub-Investigator: Philip Caenepeel, M.D.         
UZ Gent Recruiting
Gent, Oost-Vlaanderen, Belgium, 9000
Contact: Sabine Van de Moortele    +32 9 332 68 54    Sabine.VandeMoortele@uzgent.be   
Contact: Muriël Fouquet    +32 9 332 33 36    Muriel.Fouquet@uzgent.be   
Sub-Investigator: Danny De Looze, M.D.         
AZ Sint-Elizabeth Zottegem Recruiting
Zottegem, Oost-Vlaanderen, Belgium, 9620
Contact: Inge Vanslembrouck, M.D.    +32 93 64 83 41    inge.vanslembrouck@sezz.be   
Contact: Inge Vanslembrouck, M.D.    +32 93 64 83 43    inge.vanslembrouck@sezz.be   
Sub-Investigator: Sebastien Kindt, M.D.         
UZ Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Lien Beullens, MSc    0032-16-341943    lien.beullens@kuleuven.be   
Contact: Dafne Balemans    0032-16-330158    dafne.balemans@med.kuleuven.be   
Principal Investigator: Guy Boeckxstaens, M.D.         
AZ Sint-Lucas Brugge Recruiting
Brugge, West-Vlaanderen, Belgium, 8310
Contact: Hilde Nevens    +32 50 36 57 11    hilde.nevens@stlucas.be   
Contact: Joris Arts, M.D.    +32 50 36 51 55    jar@stlucas.be   
Sub-Investigator: Joris Arts, M.D.         
Netherlands
Rijnstate Not yet recruiting
Arnhem, Gelderland, Netherlands, 6800
Contact: B.G. Baten, M.D.    0031 88 005 6671      
Contact: D. Hirsch, M.D.       DHirsch@Rijnstate.nl   
Sub-Investigator: D. Hirsch, M.D.         
Medisch Spectrum Twente Not yet recruiting
Enschede, Limburg, Netherlands, 7500
Contact: Anita Westerhof    0031(53)4877511      
Contact: J. Kolkman, M.D.    0031 (53) 487 24 10    j.kolkman@mst.nll   
Sub-Investigator: J. Kolkman, M.D.         
AZ Maastricht Not yet recruiting
Maastricht, Limburg, Netherlands, 6202
Contact: Samefko Ludidi         
Contact: A. Masclee, M.D.       a.masclee@mumc.nl   
Sub-Investigator: A. Masclee         
Sint Lucas Andreas Ziekenhuis Not yet recruiting
Amsterdam, Noord-Holland, Netherlands, 1061
Contact: Sjoerd Kuiken, M.D.       s.kuiken@slaz.nl   
Sub-Investigator: Sjoerd Kuiken, M.D.         
Academisch Medisch Centrum Not yet recruiting
Amsterdam, Noord-Holland, Netherlands, 1105
Contact: A.J. Bredenoord, M.D.       A.J.Bredenoord@amc.uva.nl   
Sub-Investigator: A.J. Bredenoord, M.D.         
Tergooiziekenuizen Blaricum/Hilversum Not yet recruiting
Hilversum/Blaricum, Noord-Holland, Netherlands, 1213/1261
Contact: Karen Verloop    0031 (35) 539 19 25    kverloop@tergooiziekenhuizen.nl   
Contact: B. van den Elzen, M.D.       BvandenElzen@tergooiziekenhuizen.nl   
Sub-Investigator: B. van den Elzen, M.D.         
Sponsors and Collaborators
KU Leuven
Investigators
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Principal Investigator: Guy Boeckxstaens, M.D. Catholic University Leuven and Universitary Hospitals Leuven
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Responsible Party: Guy Boeckxstaens, Prof. Dr., KU Leuven
ClinicalTrials.gov Identifier: NCT01908465    
Other Study ID Numbers: S55485
First Posted: July 25, 2013    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Ebastine
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs