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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02179658
Recruitment Status : Completed
First Posted : July 2, 2014
Last Update Posted : September 29, 2016
Information provided by (Responsible Party):
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).

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 Type : Interventional  (Clinical Trial)
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)
Study Start Date : May 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Arm Intervention/treatment
Experimental: OPT-80 group
Drug: OPT-80
Other Name: fidaxomicin
Active Comparator: Vancomycin group
Drug: vancomycin

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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Astellas Pharma Inc Identifier: NCT02179658     History of Changes
Other Study ID Numbers: 2819-CL-3002
First Posted: July 2, 2014    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
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