A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea

Completed · Phase 2

Conditions studied: Clostridium Difficile-Associated Diarrhea, Clostridium Enterocolitis, Clostridium Difficile Diarrhea, Antibiotic-associated Colitis, Antibiotic-associated Diarrhea

In brief

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.

Key facts

Study ID

NCT00034294

Run by

Genzyme, a Sanofi Company

People needed

300

Starts

2002-02-01

Expected to finish

2003-07-01

Last updated by the study team

2015-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be at least 18 years old.
• Have active mild to moderate C. difficile- Associated Diarrhea (CDAD).
• Be able to tolerate oral medication.
• Not be pregnant or breast-feeding.
• Sign and date an informed consent form.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Sacramento, California, United States
• Study site — Newark, Delaware, United States
• Study site — Bay Pines, Florida, United States
• Study site — Brandon, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — Naples, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Austell, Georgia, United States
• Study site — Columbus, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Maywood, Illinois, United States
• Study site — North Chicago, Illinois, United States
• Study site — Columbus, Indiana, United States
• Study site — Des Moines, Iowa, United States
• Study site — Des Moines, Iowa, United States
• Study site — Wichita, Kansas, United States
• Study site — Lexington, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Chevy Chase, Maryland, United States
• Study site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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