Status:
COMPLETED
PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
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 PAR-101/OPT-80 (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 PAR-101/OPT-80 versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD). The cure ra...
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 :
October 4 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2009
Estimated Enrollment :
535 Patients enrolled
Trial Details
Trial ID
NCT00468728
Start Date
October 4 2006
End Date
December 11 2009
Last Update
April 21 2017
Active Locations (116)
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1
Gadsden, Alabama, United States
2
Phoenix, Arizona, United States
3
Hot Springs, Arkansas, United States
4
La Mesa, California, United States