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

March 23, 2017 updated by: Optimer Pharmaceuticals LLC

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

535

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium
      • Alast, Belgium
      • Antwerp, Belgium
      • Brussels, Belgium
      • Columbia, Belgium
      • Gent, Belgium
      • Kortrijk, Belgium
      • Liege, Belgium
      • Mons, Belgium
      • Montigny-le-Tilleul, Belgium
      • Wilrijk, Belgium
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
      • Edmonton, Alberta, Canada
    • Ontario
      • Hamilton, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Chicoutimi, Quebec, Canada
      • Montreal, Quebec, Canada
      • Sherbrooke, Quebec, Canada
      • St. Jerome, Quebec, Canada
      • Trois-Rivieres, Quebec, Canada
  • France
      • Amiens, France
      • Caen Cedex, France
      • Clichy, France
      • Garches, France
      • Grenoble, France
      • Lille, France
      • Tourcoing, France
      • Tours Cedex, France
      • Valenciennes, France
  • Germany
      • Duesseldorf, Germany
      • Frankfurt, Germany
      • Hannover, Germany
      • Hofheim am Taunus, Germany
      • Koln, Germany
      • Lubeck, Germany
      • Luebeck, Germany
      • Magdeburg, Germany
      • Regensburg, Germany
  • Italy
      • Busto Arsizio, Italy
      • Genova, Italy
      • Milan, Italy
      • Modena, Italy
      • Torino, Italy
  • Spain
      • Badalona, Spain
      • Barcelona, Spain
      • Madrid, Spain
      • Palma de Mallorca, Spain
      • Seville, Spain
  • Sweden
      • Eskilstuna, Sweden
      • Goteborg, Sweden
      • Orebro, Sweden
  • United Kingdom
      • Barnsley, United Kingdom
      • Brighton, United Kingdom
      • Cambridge, United Kingdom
      • Edinburgh, United Kingdom
      • Liege, United Kingdom
      • London, United Kingdom
      • Nottingham, United Kingdom
      • Oxford, United Kingdom
      • Oxon, United Kingdom
      • Surrey, United Kingdom
      • York, United Kingdom
    • Norfolk
      • Great Yarmouth, Norfolk, United Kingdom
    • Plymouth
      • Derriford, Plymouth, United Kingdom
  • United States
    • Alabama
      • Gadsden, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
    • Arkansas
      • Hot Springs, Arkansas, United States
    • California
      • La Mesa, California, United States
      • Modesto, California, United States
      • Palm Springs, California, United States
      • Rancho Mirage, California, United States
      • San Jose, California, United States
      • Santa Ana, California, United States
      • Vallejo, California, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Miami, Florida, United States
      • Port Orange, Florida, United States
      • Sarasota, Florida, United States
    • Georgia
      • Marietta, Georgia, United States
      • Savannah, Georgia, United States
    • Idaho
      • Idaho Falls, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
      • Maywood, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Kentucky
      • Bowling Green, Kentucky, United States
    • Louisiana
      • Jena, Louisiana, United States
      • New Orleans, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • West Roxbury, Massachusetts, United States
    • Michigan
      • Detroit, Michigan, United States
      • Keego Harbor, Michigan, United States
      • Royal Oak, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Mississippi
      • Tupelo, Mississippi, United States
    • Missouri
      • Columbia, Missouri, United States
    • Montana
      • Butte, Montana, United States
    • New Jersey
      • Cedar Knolls, New Jersey, United States
      • Neptune, New Jersey, United States
    • New York
      • Bronx, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • North Dakota
      • Fargo, North Dakota, United States
    • Ohio
      • Akron, Ohio, United States
      • Amherst, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Dayton, Ohio, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
    • South Dakota
      • Rapid City, South Dakota, United States
      • Sioux Falls, South Dakota, United States
    • Texas
      • San Antonio, Texas, United States
    • Virginia
      • Winchester, Virginia, United States
    • Washington
      • Seattle, Washington, United States
    • West Virginia
      • Charlestown, West Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Vancomycin
Drug: Vancomycin
Capsules
Experimental: 2
PAR-101/OPT-80
Drug: PAR-101/OPT-80
capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Study day 10 (+/- 2 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Study days 11-40
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.
End of Study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Optimer Pharmaceuticals LLC

Investigators

  • Study Director: Dr. Sherwood Gorbach, MD, Optimer Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2006

Primary Completion (Actual)

December 11, 2009

Study Completion (Actual)

December 11, 2009

Study Registration Dates

First Submitted

May 1, 2007

First Submitted That Met QC Criteria

May 1, 2007

First Posted (Estimate)

May 3, 2007

Study Record Updates

Last Update Posted (Actual)

April 21, 2017

Last Update Submitted That Met QC Criteria

March 23, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5119-019
  • 101.1.C.004 (Other Identifier: Optimerpharma Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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