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