Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 12:01 AM
Study NCT ID:
NCT00196794
Status:
COMPLETED
Last Update Posted:
2014-03-19
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy']}, 'conditionBrowseModule': {'meshes': [{'id': 'D004761', 'term': 'Enterocolitis, Pseudomembranous'}, {'id': 'D003967', 'term': 'Diarrhea'}], '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'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 520}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-17', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2014-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resolution of diarrhea'}], 'secondaryOutcomes': [{'measure': 'Time to resolution of diarrhea'}, {'measure': 'Recurrence rate'}, {'measure': 'Number of stools'}, {'measure': 'Average stool consistency'}, {'measure': 'Treatment success'}]}, 'conditionsModule': {'keywords': ['Pseudomembranous Colitis', 'Clostridium difficile-associated diarrhea', 'C. difficile', 'CDAD'], 'conditions': ['Clostridium Enterocolitis', 'Diarrhea']}, 'referencesModule': {'references': [{'pmid': '24799326', 'type': 'DERIVED', 'citation': 'Johnson S, Louie TJ, Gerding DN, Cornely OA, Chasan-Taber S, Fitts D, Gelone SP, Broom C, Davidson DM; Polymer Alternative for CDI Treatment (PACT) investigators. Vancomycin, metronidazole, or tolevamer for Clostridium difficile infection: results from two multinational, randomized, controlled trials. Clin Infect Dis. 2014 Aug 1;59(3):345-54. doi: 10.1093/cid/ciu313. Epub 2014 May 5.'}]}, 'descriptionModule': {'briefSummary': 'Approximately 520 patients will be entered into this study taking place throughout Australia and Europe. This study aims to determine if an investigational drug is safe and effective for treating symptoms of C. difficile-associated diarrhea (CDAD) and lowering the risk of repeat episodes of CDAD. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication. All study related care is provided including doctor visits, physical exams, laboratory tests, and study medication. The total length of participation is approximately 6 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age and above\n* The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea\n* Less than or equal to 48 hours of treatment with metronidazole, vancomycin or other antibacterial therapy specific for CDAD\n* Baseline serum potassium \\> 3.0 mmol (meq)/L\n* Patient considered sufficiently stable clinically to likely complete 6 week study period.'}, 'identificationModule': {'nctId': 'NCT00196794', 'briefTitle': 'A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Double-Blind Study of GT267-004 Versus Vancomycin, and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea', 'orgStudyIdInfo': {'id': 'GD3-170-302'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tolevamer potassium-sodium (GT267-004)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide', 'country': 'Australia', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '5042', 'city': 'Bedford Park', 'country': 'Australia', 'geoPoint': {'lat': -35.02204, 'lon': 138.56815}}, {'zip': '4870', 'city': 'Cairns', 'country': 'Australia', 'geoPoint': {'lat': -16.92366, 'lon': 145.76613}}, {'zip': '2139', 'city': 'Concord', 'country': 'Australia', 'geoPoint': {'lat': -33.84722, 'lon': 151.10381}}, {'zip': '2010', 'city': 'Darlinghurst', 'country': 'Australia', 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': '2046', 'city': 'Five Dock', 'country': 'Australia', 'geoPoint': {'lat': -33.8674, 'lon': 151.12905}}, {'zip': '3011', 'city': 'Footscray', 'country': 'Australia', 'geoPoint': {'lat': -37.8, 'lon': 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