Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-26 @ 12:39 AM
Study NCT ID:
NCT00309660
Status:
UNKNOWN
Last Update Posted:
2006-09-21
First Post:
2006-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment With Local PPARgamma Ligand in Distal Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077154', 'term': 'Rosiglitazone'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2007-06'}, 'lastUpdateSubmitDate': '2006-09-20', 'studyFirstSubmitDate': '2006-03-30', 'studyFirstSubmitQcDate': '2006-03-31', 'lastUpdatePostDateStruct': {'date': '2006-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical response'}], 'secondaryOutcomes': [{'measure': 'Endoscopic response'}]}, 'conditionsModule': {'keywords': ['PPARgamma ligand', 'Rosiglitazone', 'Enema'], 'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'Treatment with PPARgamma ligands have been shown to reduces intestinal inflammation in murine models of colitis. The aim of this study was to evaluate the effect of treatment with local PPARgamma ligand (rosiglitazone) in distal ulcerative colitis.The patients are treated with rosiglitazone enema, once a day, for fourteen days. Disease activity was assessed before and after treatment by endoscopical and clinical activity score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Distal ulcerative colitis (Mayo Clinical Score \\> 7)\n* Age \\> 18 years\n* Written consent\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Severe ulcerative colitis\n* Systemic treatment with steroids or azathioprin within the last 3 month\n* Known liver or kidney disease\n* Severe heart failure\n* Pregnancy or breast feeding'}, 'identificationModule': {'nctId': 'NCT00309660', 'briefTitle': 'Treatment With Local PPARgamma Ligand in Distal Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'orgStudyIdInfo': {'id': 'PPAR2005'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Rosiglitazone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Gitte Pedersen, MD', 'role': 'CONTACT', 'email': 'gitped01@herlevhosp.kbhamt.dk', 'phone': '+45 44883418'}, {'name': 'Gitte Pedersen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dept. Gastroenterology C, Herlev University Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'centralContacts': [{'name': 'Gitte Pedersen', 'role': 'CONTACT', 'email': 'gitped01@herlevhosp.kbhamt.dk', 'phone': '+ 45 44883418'}], 'overallOfficials': [{'name': 'Jørn Brynskov, Ass. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept Gastroenterology C, Herlev University Hospital, 2730 Herlev, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev Hospital', 'class': 'OTHER'}}}}