At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 535 enrolled
Drug / intervention
PAR-101/OPT-80 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind Study to Compare the Safety and Efficacy of PAR-101 to Vancomycin in Subjects With Clostridium Difficile-Associated Diarrhea (CDAD)
Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted May 3, 2007·Updated Apr 21, 2017
In Brief
A Phase 3 clinical trial evaluating PAR-101/OPT-80 and Vancomycin for Clostridium Infections and Diarrhea. Completed, enrolled 535 participants across 116 sites in 9 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClostridium Infections, Diarrhea
CountriesBelgium, Canada, France, Germany, Italy, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2006
First PostedMay 2007
Primary CompletionDec 2009
TodayJul 2026
First PostedMay 3, 2007
Enrollment StartOct 4, 2006
Primary CompletionDec 11, 2009
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 19.2 years ago
Interventions
PAR-101/OPT-80drug
capsules
Vancomycindrug
Capsules