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

This study has been completed.

First Received: April 13, 2006 Last Updated: August 27, 2008 History of Changes

Sponsored by:	Optimer Pharmaceuticals
Information provided by:	Optimer Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00314951

Purpose

This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80 versus vancomycin in subjects with CDAD.

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

MedlinePlus related topics: Diarrhea

Drug Information available for: Vancomycin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind Study to Compare the Safety and Efficacy of PAR-101 to Vancomycin in Subjects With Clostridium Difficile-Associated Diarrhea

Further study details as provided by Optimer Pharmaceuticals:

Primary Outcome Measures:

Cure rate at end of therapy [ Time Frame: End of Therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Recurrence rate [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Estimated Enrollment:	664
Study Start Date:	April 2006
Study Completion Date:	August 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Capsule

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. 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314951

Show 58 Study Locations

Sponsors and Collaborators

Optimer Pharmaceuticals

Investigators

Study Director:

Dr. Sherwood Gorbach, MD

Optimer Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Optimer Pharmaceuticals ( Y.K. Shue )
Study ID Numbers:	PAR-101/OPT-80 2B/3, 101.1.C.003
Study First Received:	April 13, 2006
Last Updated:	August 27, 2008
ClinicalTrials.gov Identifier:	NCT00314951 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Optimer Pharmaceuticals:

CDAD, Clostridium difficile, diarrhea
Clostridium difficile-Associated Diarrhea

Study placed in the following topic categories:

Bacterial Infections
Signs and Symptoms
Gram-Positive Bacterial Infections
Diarrhea

Signs and Symptoms, Digestive
Vancomycin
Clostridium Difficile
Clostridium Infections

Additional relevant MeSH terms:

Bacterial Infections
Signs and Symptoms
Gram-Positive Bacterial Infections
Diarrhea

Signs and Symptoms, Digestive
Infection
Clostridium Infections

ClinicalTrials.gov processed this record on May 07, 2009