Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-25 @ 2:47 PM
Study NCT ID:
NCT00180050
Status:
COMPLETED
Last Update Posted:
2010-03-30
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Budesonide Treatment for Lymphocytic Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046728', 'term': 'Colitis, Microscopic'}, {'id': 'D046730', 'term': 'Colitis, Lymphocytic'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019819', 'term': 'Budesonide'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-29', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2010-03-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients in clinical remission after 6 weeks'}], 'secondaryOutcomes': [{'measure': 'safety'}, {'measure': 'quality of life'}, {'measure': 'histological improvement'}]}, 'conditionsModule': {'keywords': ['lymphocytic colitis', 'microscopic colitis', 'budesonide'], 'conditions': ['Microscopic Colitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis', 'detailedDescription': 'The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* lymphocytic colitis\n* diarrhea\n* effective contraception\n* written informed consent\n\nExclusion Criteria:\n\n* other forms if IBD\n* celiac disease\n* infectious colitis\n* history of colonic surgery\n* use of budesonide, 5-ASA, steroids within th previous 4 weeks\n* pregnancy, lactation'}, 'identificationModule': {'nctId': 'NCT00180050', 'briefTitle': 'Budesonide Treatment for Lymphocytic Colitis', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Efficacy and Safety of Budesonide for Treatment of Lymphocytic Colitis', 'orgStudyIdInfo': {'id': 'BLYCK'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Budesonide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Medical Department I, Technical University Hospital', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'overallOfficials': [{'name': 'Stephan Miehlke, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Department I, Technical University Hospital, Dresden, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dr. Falk Pharma GmbH', 'class': 'INDUSTRY'}]}}}