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Keep this study
Lead
Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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 rates at end of therapy and recurrence rates will be evaluated and compared.
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Males/females with CDAD
Females must use adequate contraception
Signed informed consent
You may not be if
Life-threatening CDAD
Toxic megacolon
Pregnant
Concurrent use of diarrheal agents
Participation in other trials
Clareo Health | PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
