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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
  Purpose
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).

Condition Intervention Phase
Clostridium Infections Diarrhea Drug: PAR-101/OPT-80 Drug: Vancomycin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Optimer Pharmaceuticals LLC:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 535
Actual Study Start Date: October 4, 2006
Study Completion Date: December 11, 2009
Primary Completion Date: December 11, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Vancomycin
Drug: Vancomycin
Capsules
Experimental: 2
PAR-101/OPT-80
Drug: PAR-101/OPT-80
capsules

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


  Show 117 Study Locations
Sponsors and Collaborators
Optimer Pharmaceuticals LLC
Investigators
Study Director: Dr. Sherwood Gorbach, MD Optimer Pharmaceuticals, Inc.
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Optimer Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT00468728     History of Changes
Obsolete Identifiers: NCT00427869
Other Study ID Numbers: 5119-019
101.1.C.004 ( Other Identifier: Optimerpharma Study Number )
First Submitted: May 1, 2007
First Posted: May 3, 2007
Results First Submitted: July 1, 2011
Results First Posted: July 29, 2011
Last Update Posted: April 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
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


Keywords provided by Optimer Pharmaceuticals LLC:
CDAD, Clostridium difficile, diarrhea
Clostridium difficile-Associated Diarrhea

Additional relevant MeSH terms:
Diarrhea
Clostridium Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Gram-Positive Bacterial Infections
Bacterial Infections
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents