A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00034294|
Recruitment Status : Completed
First Posted : April 25, 2002
Last Update Posted : March 5, 2015
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.
All study-related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is approximately 10 weeks.
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile-Associated Diarrhea Clostridium Enterocolitis Clostridium Difficile Diarrhea Antibiotic-associated Colitis Antibiotic-associated Diarrhea||Drug: GT160-246||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Double-Blind Study of GT160-246 Versus Vancomycin in Patients With C. Difficile-Associated Diarrhea|
|Study Start Date :||February 2002|
|Actual Study Completion Date :||July 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00034294
|Study Director:||Medical Monitor||Genzyme, a Sanofi Company|