Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018)

Last updated: March 23, 2017
Sponsor: Optimer Pharmaceuticals LLC
Overall Status: Completed

Phase

3

Condition

Colic

Lactose Intolerance

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT00314951
5119-018
101.1.C.003
  • Ages > 16
  • All Genders

Study Summary

This is a comparative study to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males/females with CDAD

  • Females must use adequate contraception

  • Signed informed consent

Exclusion

Exclusion Criteria:

  • Life-threatening CDAD

  • Toxic megacolon

  • Pregnant

  • Concurrent use of diarrheal agents

  • Participation in other trials

Study Design

Total Participants: 629
Study Start date:
May 02, 2006
Estimated Completion Date:
August 21, 2008

Study Description

The primary objective of this pivotal study is to investigate the safety and efficacy of fidaxomicin 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.

Connect with a study center

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    Calgary, Alberta
    Canada

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    New Westminster, British Columbia
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    Surrey, British Columbia
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    Ajax, Ontario
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    Hamilton, Ontario
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    Ottawa, Ontario
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    Toronto, Ontario
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    Windsor, Ontario
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    Chicoutimi, Quebec
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    Levis, Quebec
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    Montreal, Quebec
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    Quebec City, Quebec
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    Sherbrooke, Quebec
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    Saskatoon, Saskatchewan
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    Quebec,
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    Dothan, Alabama
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    Hot Springs, Arkansas
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    Long Beach, California
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    San Diego, California
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    Stamford, Connecticut
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    Clearwater, Florida
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    Gainesville, Florida
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    Smyrna Beach, Florida
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    Decatur, Georgia
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    Marietta, Georgia
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    Idaho Falls, Idaho
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    Chicago, Illinois
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    South Bend, Indiana
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    Jena, Louisiana
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    Baltimore, Maryland
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    Boston, Massachusetts
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    Springfield, Massachusetts
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    Detroit, Michigan
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    Keego Harbor, Michigan
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    Minneapolis, Minnesota
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    Rochester, Minnesota
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    St. Louis, Missouri
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    Butte, Montana
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    Camden, New Jersey
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    Neptune, New Jersey
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    Newark, New Jersey
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    Albany, New York
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    Buffalo, New York
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    New York, New York
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    Charlotte, North Carolina
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    Winston-Salem, North Carolina
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    Akron, Ohio
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    Cleveland, Ohio
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    Columbus, Ohio
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    Toledo, Ohio
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    Portland, Oregon
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    Allentown, Pennsylvania
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    Johnson City, Tennessee
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    Fort Worth, Texas
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    Houston, Texas
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    Charlottesville, Virginia
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    Madison, Wisconsin
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