Clinical Trial: A Study of the Absorption of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Study of the Pharmacokinetics of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea

Brief Summary: Approximately 24 patients will be entered into this study taking place in Canada. The aim of this study is to determine if an investigational drug is absorbed (taken up) in patients with C. difficile-associated diarrhea (CDAD). The investigational drug will be given in addition to current standard antibiotic treatment so that 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 7 days.

Detailed Summary:
Sponsor: Genzyme, a Sanofi Company

Current Primary Outcome: The extent of GT267-004 absorption as measured in the blood and urine by pharmacokinetic analysis

Original Primary Outcome: The extent of GT267-004 absorption as measured in the blood and urine by pharmacokinetic analysis.

Current Secondary Outcome: Safety as measured by physical examinations (including vital signs), adverse events and changes in safety laboratory values

Original Secondary Outcome: Safety as measured by physical examinations (including vital signs), adverse events and changes in safety laboratory values.

Information By: Sanofi

Dates:
Date Received: September 27, 2006
Date Started: September 2006
Date Completion:
Last Updated: March 17, 2015
Last Verified: March 2015