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

Phase 3

Completed

• Conditions: Clostridium Difficile
• Interventions: Drug: OPT-80; Drug: vancomycin

• Registration Number: NCT02179658
• Lead Sponsor: Astellas Pharma Inc

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).

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 Timeline

• Study Start: 2014-06-23
• Study First Submitted: 2014-06-30
• Study First Submitted QC: 2014-06-30
• Study First Posted: 2014-07-02
• Primary Completion: 2016-09-08
• Study Completion: 2016-09-08
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OPT-80 group	OPT-80	Oral
Vancomycin group	vancomycin	Oral

Primary Outcome Measures

Name	Time	Method
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

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