NCT00466635

A Study to Assess the Safety, Tolerability, Effectiveness and Absorption of Exodif™ Tablets in Clostridium Difficile-associated Diarrhea

An Open-label Study to Assess the Safety, Efficacy and Absorption of Exodif™ (Tolevamer Potassium Sodium) Tablets in Patients With Clostridium Difficile-Associated Diarrhea

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Approximately 65 patients will be entered into this study taking place in North America. The aim of this study is to evaluate the safety, efficacy and absorption of an investigational drug in patients with C. difficile-associated diarrhea (CDAD). All study related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is 6 weeks.

Conditions

• Enterocolitis, Pseudomembranous
• Diarrhea
• Clostridium Difficile

Interventions

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

Timeline

• Start date: 2007-04-01
• Completion: 2007-08-01
• First posted: 2007-04-27
• Last updated: 2015-03-19

Locations

13 sites across 1 country: United States