A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C.Difficile - Associated Diarrhea

Completed · Phase 3

Conditions studied: Clostridium Enterocolitis, Pseudomembranous Colitis

In brief

Approximately 520 patients will be entered into this study taking place throughout the US and Canada. 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. Total length of participation is approximately 6 weeks.

Key facts

Study ID

NCT00106509

Run by

Genzyme, a Sanofi Company

People needed

520

Starts

2005-03-01

Expected to finish

2007-02-01

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…

• 18 years of age
• The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea
• Less than or equal to 48 hours of treatment with metronidazole, vancomycin or other antibacterial therapy specific for CDAD
• Baseline serum potassium > 3.0 mmol (meq)/L
• Patient considered sufficiently stable clinically to likely complete a 6 week study period

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Rogers, Arkansas, United States
• Study site — Burbank, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Modesto, California, United States
• Study site — Newport Beach, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — Denver, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Newark, Delaware, United States
• Study site — Bay Pines, Florida, United States
• Study site — Brandon, Florida, United States
• Study site — Brooksville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Zephyrhills, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Fort Eisenhower, Georgia, United States
• Study site — Savannah, Georgia, United States
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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