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Trial record 1 of 9 for:    opt-80
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A Study to Compare Safety and Efficacy of OPT-80(Fidaxomicin) With Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD)

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: June 30, 2014
Last updated: September 27, 2016
Last verified: September 2016
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 Intervention Phase
Clostridium Difficile
Drug: OPT-80
Drug: vancomycin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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)

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

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

Enrollment: 210
Study Start Date: May 2014
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OPT-80 group
Drug: OPT-80
Other Name: fidaxomicin
Active Comparator: Vancomycin group
Drug: vancomycin

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.

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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, 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, 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
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Please refer to this study by its identifier: NCT02179658

Chubu, Japan
Chugoku, Japan
Hokkaido, Japan
Kanto, Japan
Kinnki, Japan
Kyushu, Japan
Touhoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Medical Director Astellas Pharma Inc
  More Information

Responsible Party: Astellas Pharma Inc Identifier: NCT02179658     History of Changes
Other Study ID Numbers: 2819-CL-3002
Study First Received: June 30, 2014
Last Updated: September 27, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc:

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents processed this record on April 21, 2017