Status:
COMPLETED
Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018)
Lead Sponsor:
Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Clostridium Infections
Diarrhea
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
This is a comparative study to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).
Detailed Description
The primary objective of this pivotal study is to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD). The cure rates...
Eligibility Criteria
Inclusion
- Males/females with CDAD
- Females must use adequate contraception
- Signed informed consent
Exclusion
- Life-threatening CDAD
- Toxic megacolon
- Pregnant
- Concurrent use of diarrheal agents
- Participation in other trials
Key Trial Info
Start Date :
May 2 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2008
Estimated Enrollment :
629 Patients enrolled
Trial Details
Trial ID
NCT00314951
Start Date
May 2 2006
End Date
August 21 2008
Last Update
April 21 2017
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