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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.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT02179658
First received: June 30, 2014
Last updated: September 27, 2016
Last verified: September 2016
  Purpose
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Recurrence rate of CDAD [ Time Frame: during the 4-week follow-up period, up to Day 38 ] [ Designated as safety issue: No ]
  • Time to resolution of diarrhea [ Time Frame: up to 38 days ] [ Designated as safety issue: No ]
  • Microbiological efficacy [ Time Frame: Up to 38 days ] [ Designated as safety issue: No ]
  • Plasma concentration of OPT-80(fidaxomicin) [ Time Frame: Before administration, Day 1 and Day 10-11 ] [ Designated as safety issue: No ]
  • Plasma concentration of OP-1118 [ Time Frame: Before administration, Day 1 and Day 10-11 ] [ Designated as safety issue: No ]
  • Fecal concentration of OPT-80(fidaxomicin) [ Time Frame: Day 10-11 ] [ Designated as safety issue: No ]
  • Fecal concentration of OP-1118 [ Time Frame: Day 10-11 ] [ Designated as safety issue: No ]
  • Safety assessed by the incidence of adverse events, vital signs, ECGs and laboratory tests [ Time Frame: Up to 38 days ] [ Designated as safety issue: No ]

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
Oral
Drug: OPT-80
oral
Other Name: fidaxomicin
Active Comparator: Vancomycin group
Oral
Drug: vancomycin
oral

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.
  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02179658

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

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT02179658     History of Changes
Other Study ID Numbers: 2819-CL-3002 
Study First Received: June 30, 2014
Last Updated: September 27, 2016
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc:
Clostridium
Infections
Difficile
Vancomycin
Fidaxomicin

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 30, 2016