Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 10:06 PM
Study NCT ID:
NCT00259558
Status:
COMPLETED
Last Update Posted:
2007-02-12
First Post:
2005-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-02', 'completionDateStruct': {'date': '2006-03'}, 'lastUpdateSubmitDate': '2007-02-07', 'studyFirstSubmitDate': '2005-11-25', 'studyFirstSubmitQcDate': '2005-11-25', 'lastUpdatePostDateStruct': {'date': '2007-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute change in clinical activity index (Rachmilewitz).'}], 'secondaryOutcomes': [{'measure': 'Secondary end points include >50% changes in clinical and endoscopic activity index (EAI).'}, {'measure': 'Histology and life quality are reported descriptively.'}]}, 'conditionsModule': {'keywords': ['Ulcerative Colitis', 'Dose Finding', 'Phosphatidylcholine'], 'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '15951544', 'type': 'BACKGROUND', 'citation': 'Stremmel W, Merle U, Zahn A, Autschbach F, Hinz U, Ehehalt R. Retarded release phosphatidylcholine benefits patients with chronic active ulcerative colitis. Gut. 2005 Jul;54(7):966-71. doi: 10.1136/gut.2004.052316.'}, {'pmid': '20048683', 'type': 'DERIVED', 'citation': 'Stremmel W, Braun A, Hanemann A, Ehehalt R, Autschbach F, Karner M. Delayed release phosphatidylcholine in chronic-active ulcerative colitis: a randomized, double-blinded, dose finding study. J Clin Gastroenterol. 2010 May-Jun;44(5):e101-7. doi: 10.1097/MCG.0b013e3181c29860.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find the optimal dose of retarded release Phosphatidylcholine in the most severe form of ulcerative colitis.\n\nThe hypothesis is that ulcerative colitis (UC) is caused by a barrier dysfunction of the colonic mucus layer. The background of the study is the finding, that the phosphatidylcholine (PC) content of the colonic mucus is strongly reduced in UC compared to healthy controls and patients with Crohn´s disease. The content was meuasured in non-inflamed areas of the colon in UC. Thus, we evaluate whether a substitution of colonic PC is an effective method.', 'detailedDescription': 'Design: prospective, randomized, double-blind, dose-finding study with retarded phosphatidylcholine.\n\nPopulation: 10 patients per dose group (6 doses) - 60 patients Remark: this includes to historic groups from another study Inclusion criteria: Ulcerative Pancolitis with chronic active course and a clinical index (Rachmilewitz) over 7 and more, endoscopic index of at least 7 or more. No systemic steroids or immunosuppressants since 4 weeks.\n\nExclusion criteria: Pregnancy \\& fulminant course'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic active ulcerative pancolitis\n* course more than 4 months\n* clinical index rachmilewitz 7 or more\n* endoskopic index 7 or more\n\nExclusion Criteria:\n\n* steroids in the last 4 weeks\n* immunosuppressants in the last 4 weeks\n* use of topical klymsa\n* pregnancy\n* fulminant course\n* infectious colitis'}, 'identificationModule': {'nctId': 'NCT00259558', 'briefTitle': 'Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Prospektive, Randomisierte Doppelblinde Studie Zur Dosisfindung Von Intestinal Redardiert Freigesetztem Phosphatidylcholin Bei Chronisch Aktiver Pancolitis Ulcerosa', 'orgStudyIdInfo': {'id': 'PC3'}, 'secondaryIdInfos': [{'id': 'EC - L069/2003'}, {'id': 'BFARM - 402 2919'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'retarded release phosphatidylcholine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Medical Hospital Unversity Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Wolfgang Stremmel, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Heidelberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Prof. Wolfgang Stremmel', 'class': 'UNKNOWN'}, {'name': 'Dietmar Hopp Stiftung', 'class': 'OTHER'}]}}}