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

This study has been completed.
Sponsor:
Information provided by:
Optimer Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00468728
First received: May 1, 2007
Last updated: August 8, 2011
Last verified: August 2011

May 1, 2007
August 8, 2011
April 2007
November 2009   (final data collection date for primary outcome measure)
Cure Rate at End of Therapy [ Time Frame: Study day 10 (+/- 2 days) ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 2009
November 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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   United States,   United Kingdom,   Canada,   France,   Germany,   Italy,   Spain,   Sweden
 
NCT00468728
101.1.C.004, 101.1.C.004
No
Y.K. Shue, Optimer Pharmaceuticals
Optimer Pharmaceuticals
Not Provided
Study Director: Dr. Sherwood Gorbach, MD Optimer Pharmaceuticals, Inc.
Optimer Pharmaceuticals
August 2011

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