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

Diarrhea Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00468728
• Other study ID #: 101.1.C.004
• Secondary ID: 101.1.C.004
• Status: Completed
• Phase: Phase 3
• First received: May 1, 2007
• Last updated: August 8, 2011
• Start date: April 2007
• Est. completion date: December 2009

Study information

• Verified date: August 2011
• Source: Optimer Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Ministry of Health and ConsumptionBelgium: Federal Agency for Medicinal Products and Health ProductsItaly: The Italian Medicines AgencySweden: Medical Products AgencyGermany: BfArM
• Study type: Interventional

Clinical Trial Summary

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).

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.

Other known NCT identifiers

• NCT00427869

Recruitment information / eligibility

• Status: Completed
• Enrollment: 535
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clostridium Infections
• Diarrhea

Intervention

Drug:
• PAR-101/OPT-80
capsules
• Vancomycin
Capsules

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Optimer Pharmaceuticals LLC

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Italy,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure Rate at End of Therapy	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)	No
Secondary	Recurrence	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	No
Secondary	Global Cure	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	No