NCT00468728

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

A Double-Blind Study to Compare the Safety and Efficacy of PAR-101 to Vancomycin in Subjects With Clostridium Difficile-Associated Diarrhea (CDAD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 535 (actual)
• Sponsor: Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Clostridium Infections
• Diarrhea

Interventions

Type	Name	Description
DRUG	PAR-101/OPT-80	capsules
DRUG	Vancomycin	Capsules

Timeline

• Start date: 2006-10-04
• Primary completion: 2009-12-11
• Completion: 2009-12-11
• First posted: 2007-05-03
• Last updated: 2017-04-21
• Results posted: 2011-07-29

Locations

116 sites across 9 countries: United States, Belgium, Canada, France, Germany, Italy, Spain, Sweden, United Kingdom