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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT02179658

Collaborator

(none)

210

Enrollment

Locations

Arms

26.5

Actual Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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	Intervention/Treatment	Phase
Clostridium Difficile	Drug: OPT-80 Drug: vancomycin	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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 :

Jun 23, 2014

Actual Primary Completion Date :

Sep 8, 2016

Actual Study Completion Date :

Sep 8, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OPT-80 group Oral	Drug: OPT-80 oral Other Names: fidaxomicin
Active Comparator: Vancomycin group Oral	Drug: vancomycin oral

Arm

Intervention/Treatment

Experimental: OPT-80 group

Oral

Drug: OPT-80

oral

Other Names:

fidaxomicin

Active Comparator: Vancomycin group

Oral

Drug: vancomycin

oral

Outcome Measures

Primary Outcome Measures

Global cure rate [Up to 38 days]
Global cure rate is the rate of the subjects satisfying both of the following: being cured at the completion of study drug administration; without recurrence during the follow-up period

Secondary Outcome Measures

Cure rate [Day 10 -11 of the study period]
Recurrence rate of CDAD [during the 4-week follow-up period, up to Day 38]
Time to resolution of diarrhea [up to 38 days]
Microbiological efficacy [Up to 38 days]
Plasma concentration of OPT-80(fidaxomicin) [Before administration, Day 1 and Day 10-11]
Plasma concentration of OP-1118 [Before administration, Day 1 and Day 10-11]
Fecal concentration of OPT-80(fidaxomicin) [Day 10-11]
Fecal concentration of OP-1118 [Day 10-11]
Safety assessed by the incidence of adverse events, vital signs, ECGs and laboratory tests [Up to 38 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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