Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-29 @ 8:19 PM
Study NCT ID:
NCT00382304
Status:
COMPLETED
Last Update Posted:
2015-03-19
First Post:
2006-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Absorption of GT267-004 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-17', 'studyFirstSubmitDate': '2006-09-27', 'studyFirstSubmitQcDate': '2006-09-27', 'lastUpdatePostDateStruct': {'date': '2015-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The extent of GT267-004 absorption as measured in the blood and urine by pharmacokinetic analysis'}], 'secondaryOutcomes': [{'measure': 'Safety as measured by physical examinations (including vital signs), adverse events and changes in safety laboratory values'}]}, 'conditionsModule': {'keywords': ['Clostridium difficile-associated diarrhea', 'C. difficile', 'CDAD', 'Clostridium difficile', 'Clostridium difficile Disease', 'Clostridium Enterocolitis', 'Antibiotic-Associated Colitis', 'Infectious diarrhea'], 'conditions': ['Pseudomembranous Colitis', 'Clostridium Difficile Diarrhea', 'Antibiotic-Associated Diarrhea']}, 'descriptionModule': {'briefSummary': 'Approximately 24 patients will be entered into this study taking place in Canada. The aim of this study is to determine if an investigational drug is absorbed (taken up) in patients with C. difficile-associated diarrhea (CDAD). The investigational drug will be given in addition to current standard antibiotic treatment so that 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 7 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea\n\nExclusion Criteria:\n\n* \\> 72 hours of treatment with metronidazole, vancomycin, or other antibacterial therapy specifically targeting the current acute episode of CDAD\n* Patient not considered sufficiently stable clinically to complete the study period'}, 'identificationModule': {'nctId': 'NCT00382304', 'briefTitle': 'A Study of the Absorption of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Study of the Pharmacokinetics of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea', 'orgStudyIdInfo': {'id': 'TOL26700606'}}, 'armsInterventionsModule': {'interventions': [{'name': 'tolevamer potassium-sodium (GT267-004)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V9S 2B7', 'city': 'Nanaimo', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.16638, 'lon': -123.94003}}, {'zip': 'V3Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'K1H 8L6', 'city': 'Ottowa', 'state': 'Ontario', 'country': 'Canada'}, {'zip': 'L4C 4Z3', 'city': 'Richmond Hill', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.87111, 'lon': -79.43725}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G5L 5T1', 'city': 'Rimouski', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 48.44879, 'lon': -68.52396}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genzyme, a Sanofi Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genzyme, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Monitor', 'oldOrganization': 'Genzyme Corporation'}}}}