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PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00468728
First Posted: May 3, 2007
Last Update Posted: April 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Optimer Pharmaceuticals LLC
May 1, 2007
May 3, 2007
July 1, 2011
July 29, 2011
April 21, 2017
October 4, 2006
December 11, 2009   (Final data collection date for primary outcome measure)
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.
Cure Rate at End of Therapy
Complete list of historical versions of study NCT00468728 on ClinicalTrials.gov Archive Site
  • 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.
Recurrence rate
Not Provided
Not Provided
 
PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
A Double-Blind Study to Compare the Safety and Efficacy of PAR-101 to Vancomycin in Subjects With Clostridium Difficile-Associated Diarrhea (CDAD)
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).
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Clostridium Infections
  • Diarrhea
  • Drug: PAR-101/OPT-80
    capsules
  • Drug: Vancomycin
    Capsules
  • Active Comparator: 1
    Vancomycin
    Intervention: Drug: Vancomycin
  • Experimental: 2
    PAR-101/OPT-80
    Intervention: Drug: PAR-101/OPT-80

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
535
December 11, 2009
December 11, 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males/females with CDAD
  • Females must use adequate contraception
  • Signed informed consent

Exclusion Criteria:

  • Life-threatening CDAD
  • Toxic megacolon
  • Pregnant
  • Concurrent use of diarrheal agents
  • Participation in other trials
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   France,   Germany,   Italy,   Spain,   Sweden,   United Kingdom,   United States
 
 
NCT00468728
5119-019
101.1.C.004 ( Other Identifier: Optimerpharma Study Number )
No
Not Provided
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Optimer Pharmaceuticals LLC
Optimer Pharmaceuticals LLC
Not Provided
Study Director: Dr. Sherwood Gorbach, MD Optimer Pharmaceuticals, Inc.
Optimer Pharmaceuticals LLC
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP