Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
Study NCT ID:
NCT00034294
Status:
COMPLETED
Last Update Posted:
2015-03-05
First Post:
2002-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004761', 'term': 'Enterocolitis, Pseudomembranous'}, {'id': 'D004403', 'term': 'Dysentery'}], 'ancestors': [{'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004760', 'term': 'Enterocolitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C077114', 'term': 'styrenesulfonic acid polymer'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-02'}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2003-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-04', 'studyFirstSubmitDate': '2002-04-24', 'studyFirstSubmitQcDate': '2002-04-24', 'lastUpdatePostDateStruct': {'date': '2015-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-04-25', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['C. difficile-associated diarrhea', 'CDAD', 'Clostridium difficile-Associated Diarrhea', 'Clostridium enterocolitis', 'antibiotic-associated diarrhea', 'clostridium difficile colitis', 'infectious diarrhea', 'chronic diarrhea', 'antibiotic-associated colitis'], 'conditions': ['Clostridium Difficile-Associated Diarrhea', 'Clostridium Enterocolitis', 'Clostridium Difficile Diarrhea', 'Antibiotic-associated Colitis', 'Antibiotic-associated Diarrhea']}, 'descriptionModule': {'briefSummary': 'Approximately 300 patients will be entered into this study taking place throughout the United States, Canada and the United Kingdom. This study aims to determine if an investigational drug is safe and effective for treating the symptoms of C. difficile-associated diarrhea and lowering the risk of repeat episodes of diarrhea. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication.\n\nAll study-related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is approximately 10 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be at least 18 years old.\n* Have active mild to moderate C. difficile- Associated Diarrhea (CDAD).\n* Be able to tolerate oral medication.\n* Not be pregnant or breast-feeding.\n* Sign and date an informed consent form.'}, 'identificationModule': {'nctId': 'NCT00034294', 'briefTitle': 'A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Double-Blind Study of GT160-246 Versus Vancomycin in Patients With C. Difficile-Associated Diarrhea', 'orgStudyIdInfo': {'id': 'GTC-80-203'}, 'secondaryIdInfos': [{'id': 'GT1105'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'GT160-246', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '36617', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United 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