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

Completed · Phase 3

Conditions studied: Clostridium Infections, Diarrhea

In brief

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).

Key facts

Study ID

NCT00468728

Run by

Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

People needed

535

Starts

2006-10-04

Expected to finish

2009-12-11

Last updated by the study team

2017-04-21

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males/females with CDAD
• Females must use adequate contraception
• Signed informed consent

You may not qualify if…

• Life-threatening CDAD
• Toxic megacolon
• Pregnant
• Concurrent use of diarrheal agents
• Participation in other trials

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Hot Springs, Arkansas, United States
• Study site — La Mesa, California, United States
• Study site — Modesto, California, United States
• Study site — Palm Springs, California, United States
• Study site — Rancho Mirage, California, United States
• Study site — San Jose, California, United States
• Study site — Santa Ana, California, United States
• Study site — Vallejo, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Miami, Florida, United States
• Study site — Port Orange, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Marietta, Georgia, United States
• Study site — Savannah, Georgia, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Maywood, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Bowling Green, Kentucky, United States
• Study site — Jena, Louisiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Gadsden, Alabama, United States

Full record on ClinicalTrials.gov

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