drugset / Trial / NCT00034294

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

NCT00034294 ↗

Phase 2 Completed 300 enrolled Genzyme, a Sanofi Company
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2002-02
Primary completion
—
Completion
2003-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Tolevamer Other / unclassified — —