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

• Status: Completed
• Trial end date: 2009-12-11
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Optimer Pharmaceuticals LLC
• Treatments: Vancomycin

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