NCT00314951View on ClinicalTrials.gov

Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018)

PHASE3CompletedINTERVENTIONAL

Enrollment

629

Participants

Timeline

Start Date

May 2, 2006

Primary Completion Date

July 23, 2008

Study Completion Date

August 21, 2008

Conditions

Clostridium InfectionsDiarrhea

Interventions

DRUG

Fidaxomicin

200 mg oral capsules two times daily (q12h regimen)

DRUG

Vancomycin

125 mg capsules q6hr (4 times a day)

DRUG

Matching Placebo to Fidaxomicin

Matching Placebo to Fidaxomicin administered two times daily (intermittently with fidaxomicin dosing)

All Listed Sponsors

lead

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

INDUSTRY

NCT00314951 - Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018) | Biotech Hunter | Biotech Hunter