A Study to Compare Safety and Efficacy of OPT-80(Fidaxomicin) With Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
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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).
Condition or disease
Drug: OPT-80Drug: vancomycin
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.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
OPT-80 Phase III Study -A Multi-center, Double Blinded, Randomized, Parallel Group Study To Compare The Safety, Pharmacokinetics And Efficacy of OPT-80 With Vancomycin In Subjects With Clostridium Difficile-Associated Diarrhea (CDAD)
Actual Study Start Date :
June 23, 2014
Actual Primary Completion Date :
September 8, 2016
Actual Study Completion Date :
September 8, 2016
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Layout table for eligibility information
Ages Eligible for Study:
20 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."