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

Phase 3

Completed

• Conditions: Clostridium Infections; Diarrhea
• Interventions: Drug: PAR-101/OPT-80; Drug: Vancomycin

• Registration Number: NCT00468728
• Lead Sponsor: Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Brief 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).

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 Timeline

• Study Start: 2006-10-04
• Study First Submitted: 2007-05-01
• Study First Submitted QC: 2007-05-01
• Study First Posted: 2007-05-03
• Primary Completion: 2009-12-11
• Study Completion: 2009-12-11
• Disposition First Submitted: 2010-08-27
• Disposition First Submitted QC: 2010-08-27
• Disposition First Posted: 2010-08-31
• Results First Submitted: 2011-07-01
• Results First Submitted QC: 2011-07-01
• Results First Posted: 2011-07-29
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-23
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 535

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	PAR-101/OPT-80	PAR-101/OPT-80
1	Vancomycin	Vancomycin

Primary Outcome Measures

Name	Time	Method
Cure Rate at End of Therapy	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.

Secondary Outcome Measures

Name	Time	Method
Global Cure	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.
Recurrence	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.