A Study to Compare Safety and Efficacy of OPT-80(Fidaxomicin) With Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD)

Astellas

Status and phase

Completed

Phase 3

Conditions

Clostridium Difficile

Treatments

Drug: OPT-80

Drug: vancomycin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02179658

2819-CL-3002

Details and patient eligibility

About

The primary objective of this study is to investigate the safety and efficacy of OPT-80 versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

Full description

This is a multicenter, double-blind, randomized, parallel group study. The subjects who meet all of the inclusion criteria and none of the exclusion criteria will be randomized, and will orally receive either OPT-80 twice daily or vancomycin powder four times daily for 10 days. A follow-up investigation will be performed 28 (±3) days after the completion of study drug administration.

Enrollment

210 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Inpatients who have symptoms of CDAD as defined by;
- (1)Diarrhea: with ≥4 unformed bowel movements (or ≥200 mL unformed stool for subjects having rectal collection devices) and
- (2)Presence of either toxin A and/or B of C. difficile in the stool
Subjects who have not received antibacterials (vancomycin, metronidazole, et.al.) aiming at CDAD treatment before the study

Exclusion criteria

Life-threatening or fulminant CDAD
Ileus paralytic or toxic megacolon
Likelihood of death before the completion of study from any cause
Concurrent use of oral vancomycin, metronidazole, et.al. aiming at the treatment of CDAD
The anticipated need to continue other antibacterials for a period exceeding seven days from providing the informed consent
Subjects who in the opinion of the investigator require other drugs to control diarrhea
Need of change in dosage regimen of opiates during the study period
Need of change in dosage regimen of probiotic products during the study period
History/complications of ulcerative colitis or Crohn's disease
Multiple occurrences of CDAD within the past three months
Hypersensitivity to vancomycin
Previous exposure to OPT-80 (fidaxomicin)
Female patients who are pregnant, breastfeeding or possibly pregnant, or wishing to become pregnant during the course of study
Participation in other clinical research studies or Post Marketing Clinical Trials utilizing an investigational agent within one month prior to providing the informed consent or within five half-lives of the investigational agent, whichever is longer