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

This study is ongoing, but not recruiting participants.

First Received: May 1, 2007 Last Updated: November 12, 2009 History of Changes

Sponsor:	Optimer Pharmaceuticals
Information provided by:	Optimer Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00468728

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 Drug: Vancomycin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea

Drug Information available for: Vancomycin Vancomycin hydrochloride

U.S. FDA Resources

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

Enrollment:	536
Study Start Date:	April 2007
Estimated Study Completion Date:	December 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Vancomycin	Drug: Vancomycin Capsules
2: Experimental 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. 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: 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

Responsible Party:	Optimer Pharmaceuticals ( Y.K. Shue )
Study ID Numbers:	101.1.C.004, 101.1.C.004
Study First Received:	May 1, 2007
Last Updated:	November 12, 2009
ClinicalTrials.gov Identifier:	NCT00468728 History of Changes
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; France: Afssaps - French Health Products Safety Agency; 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:

Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents
Signs and Symptoms
Gram-Positive Bacterial Infections
Diarrhea

Signs and Symptoms, Digestive
Therapeutic Uses
Vancomycin
Infection
Clostridium Infections
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2009