PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
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|ClinicalTrials.gov Identifier: NCT00468728|
Recruitment Status : Completed
First Posted : May 3, 2007
Results First Posted : July 29, 2011
Last Update Posted : April 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Infections Diarrhea||Drug: PAR-101/OPT-80 Drug: Vancomycin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||535 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-Blind Study to Compare the Safety and Efficacy of PAR-101 to Vancomycin in Subjects With Clostridium Difficile-Associated Diarrhea (CDAD)|
|Actual Study Start Date :||October 4, 2006|
|Actual Primary Completion Date :||December 11, 2009|
|Actual Study Completion Date :||December 11, 2009|
Active Comparator: 1
- Cure Rate at End of Therapy [ Time Frame: Study day 10 (+/- 2 days) ]Percentage of subjects with 3 or fewer unformed stools for 2 consecutive days and maintained through the end of therapy, and the subject no longer needed specific anti-Clostridium antibacterial treatment after completion of the course of study medication.
- Recurrence [ Time Frame: Study days 11-40 ]Percentage of subjects with the re-establishment of diarrhea to an extent(based on frequency of passed unformed stools) that was greater than that noted on the last day of study medication, and the demonstration of either toxin A or B or both of C. difficile, and retreatment with CDI anti-infective therapy was needed.
- Global Cure [ Time Frame: End of Study ]Achieving a cure response at end of treatment and not having a recurrence at any time up to the post-study visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00468728
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|Study Director:||Dr. Sherwood Gorbach, MD||Optimer Pharmaceuticals, Inc.|