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

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

Status and phase: Completed; Phase 3

Conditions: Diarrhea; Clostridium Infections

Treatments: Drug: Vancomycin; Drug: PAR-101/OPT-80

Study type: Interventional

Funder types: Industry

Identifiers

NCT00468728

5119-019

101.1.C.004 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 535 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

535 participants in 2 patient groups

1

Active Comparator group

Description:

Vancomycin

Treatment:

Drug: Vancomycin

2

Experimental group

Description:

PAR-101/OPT-80

Treatment:

Drug: PAR-101/OPT-80