Trial record 3 of 20 for:    opt-80

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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 535
Study Start Date: April 2007
Study Completion Date: December 2009
Primary Completion Date: November 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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468728

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

No publications provided by Optimer Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Y.K. Shue, Optimer Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00468728     History of Changes
Obsolete Identifiers: NCT00427869
Other Study ID Numbers: 101.1.C.004, 101.1.C.004
Study First Received: May 1, 2007
Results First Received: July 1, 2011
Last Updated: August 8, 2011
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Ministry of Health and Consumption
Belgium: Federal Agency for Medicinal Products and Health Products
Italy: The Italian Medicines Agency
Sweden: Medical Products Agency
Germany: BfArM

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

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

ClinicalTrials.gov processed this record on October 22, 2014