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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)

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Clostridium Difficile

Intervention: OPT-80 (Drug); vancomycin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Astellas Pharma Inc

Overall contact:
Clinical Development Administration Dept, Email: Astellas.registration@astellas.com

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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Global cure rate

Secondary outcome:

Cure rate

Recurrence rate of CDAD

Time to resolution of diarrhea

Microbiological efficacy

Plasma concentration of OPT-80(fidaxomicin)

Plasma concentration of OP-1118

Fecal concentration of OPT-80(fidaxomicin)

Fecal concentration of OP-1118

Safety assessed by the incidence of adverse events, vital signs, ECGs and laboratory tests

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

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Clinical Development Administration Dept, Email: Astellas.registration@astellas.com

Chubu, Japan; Recruiting

Chugoku, Japan; Recruiting

Hokkaido, Japan; Recruiting

Kanto, Japan; Recruiting

Kinnki, Japan; Recruiting

Kyushu, Japan; Recruiting

Touhoku, Japan; Recruiting

Additional Information

Starting date: May 2014
Last updated: August 19, 2015

Page last updated: August 23, 2015

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