Status:
TERMINATED
A Study to Assess the Safety, Tolerability, Effectiveness and Absorption of Exodif™ Tablets in Clostridium Difficile-associated Diarrhea
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Enterocolitis, Pseudomembranous
Diarrhea
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- The presence of CDAD at the time of enrollment
- Negative serum pregnancy test (HCG) for women of childbearing potential.
Exclusion
- Any contraindication to oral / enteral therapy including fulminant C. difficile disease.
- Any acutely life-threatening medical conditions.
- Acute or chronic diarrhea of other cause.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00466635
Start Date
April 1 2007
End Date
August 1 2007
Last Update
March 19 2015
Active Locations (13)
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1
Modesto, California, United States
2
Honolulu, Hawaii, United States
3
Maywood, Illinois, United States
4
Baltimore, Maryland, United States