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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02179658
Other study ID # 2819-CL-3002
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 23, 2014
Est. completion date September 8, 2016

Study information

Verified date September 2018
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 210
Est. completion date September 8, 2016
Est. primary completion date September 8, 2016
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
OPT-80
oral
vancomycin
oral

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

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