Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT00466635
Status:
TERMINATED
Last Update Posted:
2015-03-19
First Post:
2007-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Safety, Tolerability, Effectiveness and Absorption of Exodif™ Tablets in Clostridium Difficile-associated Diarrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004761', 'term': 'Enterocolitis, Pseudomembranous'}, {'id': 'D003967', 'term': 'Diarrhea'}, {'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'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-04'}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-17', 'studyFirstSubmitDate': '2007-04-25', 'studyFirstSubmitQcDate': '2007-04-26', 'lastUpdatePostDateStruct': {'date': '2015-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Success'}, {'measure': 'Safety'}], 'secondaryOutcomes': [{'measure': 'The extent of tolevamer absorption'}]}, 'conditionsModule': {'keywords': ['Clostridium difficile Disease', 'Infectious diarrhea', 'C. difficile', 'CDAD', 'Clostridium difficile-associated diarrhea', 'Clostridium difficile diarrhea', 'Antibiotic-Associated Colitis', 'Clostridium Enterocolitis', 'Antibiotic-Associated Diarrhea', 'Pseudomembranous Colitis', 'Clostridium difficile'], 'conditions': ['Enterocolitis, Pseudomembranous', 'Diarrhea', 'Clostridium Difficile']}, 'descriptionModule': {'briefSummary': 'Approximately 65 patients will be entered into this study taking place in North America. The aim of this study is to evaluate the safety, efficacy and absorption of an investigational drug in patients with C. difficile-associated diarrhea (CDAD). All study related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is 6 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The presence of CDAD at the time of enrollment\n* Negative serum pregnancy test (HCG) for women of childbearing potential.\n\nExclusion Criteria:\n\n* Any contraindication to oral / enteral therapy including fulminant C. difficile disease.\n* Any acutely life-threatening medical conditions.\n* Acute or chronic diarrhea of other cause.'}, 'identificationModule': {'nctId': 'NCT00466635', 'briefTitle': 'A Study to Assess the Safety, Tolerability, Effectiveness and Absorption of Exodif™ Tablets in Clostridium Difficile-associated Diarrhea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'An Open-label Study to Assess the Safety, Efficacy and Absorption of Exodif™ (Tolevamer Potassium Sodium) Tablets in Patients With Clostridium Difficile-Associated Diarrhea', 'orgStudyIdInfo': {'id': 'TOL26700706'}}, 'armsInterventionsModule': {'interventions': [{'name': 'GT267-004 (tolevamer potassium sodium)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Modesto', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.6391, 'lon': -120.99688}}, {'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'city': 'West Bloomfield', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.56891, 'lon': -83.38356}}, {'city': 'Butte', 'state': 'Montana', 'country': 'United States', 'geoPoint': {'lat': 46.00382, 'lon': -112.53474}}, {'city': 'Cedar Knolls', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.82204, 'lon': -74.44876}}, {'city': 'Neptune City', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.20011, 'lon': -74.02792}}, {'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'city': 'Lancaster', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}], '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'}}}}