Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-25 @ 7:14 PM
Study NCT ID:
NCT01144832
Status:
COMPLETED
Last Update Posted:
2016-01-28
First Post:
2010-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Irritable Bowel Syndrome (IBS) Treatment With H1-receptor Antagonists
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C058249', 'term': 'ebastine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-27', 'studyFirstSubmitDate': '2010-05-28', 'studyFirstSubmitQcDate': '2010-06-15', 'lastUpdatePostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of treatment on visceral sensitivity measured with rectal barostat.', 'timeFrame': 'after 12 weeks treatment'}], 'secondaryOutcomes': [{'measure': 'Effect of treatment on IBS symptoms.', 'timeFrame': 'after 12 weeks treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['visceral hypersensitivity', 'mast cells'], 'conditions': ['Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '26752109', 'type': 'DERIVED', 'citation': 'Wouters MM, Balemans D, Van Wanrooy S, Dooley J, Cibert-Goton V, Alpizar YA, Valdez-Morales EE, Nasser Y, Van Veldhoven PP, Vanbrabant W, Van der Merwe S, Mols R, Ghesquiere B, Cirillo C, Kortekaas I, Carmeliet P, Peetermans WE, Vermeire S, Rutgeerts P, Augustijns P, Hellings PW, Belmans A, Vanner S, Bulmer DC, Talavera K, Vanden Berghe P, Liston A, Boeckxstaens GE. Histamine Receptor H1-Mediated Sensitization of TRPV1 Mediates Visceral Hypersensitivity and Symptoms in Patients With Irritable Bowel Syndrome. Gastroenterology. 2016 Apr;150(4):875-87.e9. doi: 10.1053/j.gastro.2015.12.034. Epub 2016 Jan 2.'}]}, 'descriptionModule': {'briefSummary': 'Purpose:\n\nTo evaluate the efficiency of Irritable Bowel Syndrome (IBS) patients treatment with the H1-receptor antagonist ebastine.\n\nDesign:\n\nDouble blind randomized placebo controlled trial. IBS patients receive a 12-weeks treatment with ebastine 20mg once daily or placebo (1:1 randomization).\n\nEnd points:\n\nEnd point is the effect of treatment on clinical symptoms and visceral hypersensitivity which will be evaluated with a barostat test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Irritable Bowel Syndrome (ROME III criteria)\n* age 18-65 years\n\nExclusion Criteria:\n\n* medication: antidepressants or H1-receptor antagonists\n* pregnancy, breast feeding\n* co-morbidity: severe kidney- and/or liver disease'}, 'identificationModule': {'nctId': 'NCT01144832', 'briefTitle': 'Irritable Bowel Syndrome (IBS) Treatment With H1-receptor Antagonists', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'IBS Treatment With H1-receptor Antagonists', 'orgStudyIdInfo': {'id': 'S51638'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo capsule', 'interventionNames': ['Drug: placebo capsule']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ebastine', 'interventionNames': ['Drug: ebastine']}], 'interventions': [{'name': 'ebastine', 'type': 'DRUG', 'description': '20 milligram capsule once daily', 'armGroupLabels': ['ebastine']}, {'name': 'placebo capsule', 'type': 'DRUG', 'description': 'one capsule once daily', 'armGroupLabels': ['placebo capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'country': 'Belgium', 'facility': 'University hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Guy Boeckxstaens, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Catholic University Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Guy Boeckxstaens', 'investigatorAffiliation': 'KU Leuven'}}}}