NCT00106509

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 520 (planned)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Clostridium Enterocolitis
• Pseudomembranous Colitis

Interventions

Type	Name	Description
DRUG	tolevamer potassium-sodium (GT267-004)

Timeline

• Start date: 2005-03-01
• Completion: 2007-02-01
• First posted: 2005-03-28
• Last updated: 2015-03-05

Locations

140 sites across 3 countries: United States, Canada, Puerto Rico