Clinical Trial: A Study to Assess the Safety, Tolerability, Effectiveness and Absorption of Exodif™ Tablets in Clostridium Difficile-associated Diarrhea
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: An Open-label Study to Assess the Safety, Efficacy and Absorption of Exodif™ (Tolevamer Potassium Sodium) Tablets in Patients With Clostridium Difficile-Associated Diarrhea
Brief 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.
Detailed Summary:
Sponsor: Genzyme, a Sanofi Company
Current Primary Outcome:
- Clinical Success
- Safety
Original Primary Outcome: Same as current
Current Secondary Outcome: The extent of tolevamer absorption
Original Secondary Outcome: Same as current
Information By: Sanofi
Dates:
Date Received: April 25, 2007
Date Started: April 2007
Date Completion:
Last Updated: March 17, 2015
Last Verified: March 2015
