NCT00196794

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 (actual)
• 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 Australia and Europe. 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. The total length of participation is approximately 6 weeks.

Conditions

• Clostridium Enterocolitis
• Diarrhea

Interventions

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

Timeline

• Start date: 2005-04-01
• Completion: 2007-08-01
• First posted: 2005-09-20
• Last updated: 2014-03-19

Locations

138 sites across 14 countries: Australia, Austria, Belgium, Czechia, Denmark, France, Germany, Ireland, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom