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

Study Description

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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 Design

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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

Arms and Interventions

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

Outcome Measures

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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 ]

Eligibility Criteria

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Ages Eligible for Study:	20 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT02179658 History of Changes
Other Study ID Numbers:	2819-CL-3002
First Posted:	July 2, 2014
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:

Clostridium; Infections; Difficile; Vancomycin; Fidaxomicin

Additional relevant MeSH terms:

Diarrhea; Signs and Symptoms, Digestive; Signs and Symptoms	Vancomycin; Anti-Bacterial Agents; Anti-Infective Agents