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

Purpose

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	Intervention	Phase
Clostridium Difficile	Drug: OPT-80 Drug: vancomycin	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea

Drug Information available for: Vancomycin Vancomycin hydrochloride Fidaxomicin

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Global cure rate [ Time Frame: Up to 38 days ] [ Designated as safety issue: No ]
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:

Cure rate [ Time Frame: Day 10 -11 of the study period ] [ Designated as safety issue: No ]
Recurrence rate of CDAD [ Time Frame: during the 4-week follow-up period, up to Day 38 ] [ Designated as safety issue: No ]
Time to resolution of diarrhea [ Time Frame: up to 38 days ] [ Designated as safety issue: No ]
Microbiological efficacy [ Time Frame: Up to 38 days ] [ Designated as safety issue: No ]
Plasma concentration of OPT-80(fidaxomicin) [ Time Frame: Before administration, Day 1 and Day 10-11 ] [ Designated as safety issue: No ]
Plasma concentration of OP-1118 [ Time Frame: Before administration, Day 1 and Day 10-11 ] [ Designated as safety issue: No ]
Fecal concentration of OPT-80(fidaxomicin) [ Time Frame: Day 10-11 ] [ Designated as safety issue: No ]
Fecal concentration of OP-1118 [ Time Frame: Day 10-11 ] [ Designated as safety issue: No ]
Safety assessed by the incidence of adverse events, vital signs, ECGs and laboratory tests [ Time Frame: Up to 38 days ] [ Designated as safety issue: No ]


Enrollment:	210
Study Start Date:	May 2014
Study Completion Date:	September 2016
Primary Completion Date:	September 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: OPT-80 group Oral	Drug: OPT-80 oral Other Name: fidaxomicin
Active Comparator: Vancomycin group Oral	Drug: vancomycin oral

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


Ages Eligible for Study:	20 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02179658

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


Responsible Party:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT02179658 History of Changes
Other Study ID Numbers:	2819-CL-3002
Study First Received:	June 30, 2014
Last Updated:	September 27, 2016
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency
Individual Participant Data
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

ClinicalTrials.gov processed this record on September 30, 2016