A Study to Compare Safety and Efficacy of OPT-80(Fidaxomicin) With Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD)

Clostridium Difficile Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02179658
• Other study ID #: 2819-CL-3002
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Clostridium Difficile
• Diarrhea

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

External Links

•   Link to results on the Astellas Clinical Study Results website