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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)

Primary Purpose

Clostridium Difficile

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

OPT-80

vancomycin

About this trial

This is an interventional treatment trial for Clostridium Difficile focused on measuring Clostridium, Infections, Difficile, Vancomycin, Fidaxomicin

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OPT-80 group

Vancomycin group

Arm Description

Oral

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02179658

First Posted

June 30, 2014

Last Updated

September 28, 2018

Sponsor

Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT02179658

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

June 23, 2014 (Actual)

Primary Completion Date

September 8, 2016 (Actual)

Study Completion Date

September 8, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Inc

4. Oversight

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clostridium Difficile

Keywords

Clostridium, Infections, Difficile, Vancomycin, Fidaxomicin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

210 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OPT-80 group

Arm Type

Experimental

Arm Description

Oral

Arm Title

Vancomycin group

Arm Type

Active Comparator

Arm Description

Oral

Intervention Type

Drug

Intervention Name(s)

OPT-80

Other Intervention Name(s)

fidaxomicin

Intervention Description

oral

Intervention Type

Drug

Intervention Name(s)

vancomycin

Intervention Description

oral

Primary Outcome Measure Information:

Title

Global cure rate

Description

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

Time Frame

Up to 38 days

Secondary Outcome Measure Information:

Title

Cure rate

Time Frame

Day 10 -11 of the study period

Title

Recurrence rate of CDAD

Time Frame

during the 4-week follow-up period, up to Day 38

Title

Time to resolution of diarrhea

Time Frame

up to 38 days

Title

Microbiological efficacy

Time Frame

Up to 38 days

Title

Plasma concentration of OPT-80(fidaxomicin)

Time Frame

Before administration, Day 1 and Day 10-11

Title

Plasma concentration of OP-1118

Time Frame

Before administration, Day 1 and Day 10-11

Title

Fecal concentration of OPT-80(fidaxomicin)

Time Frame

Day 10-11

Title

Fecal concentration of OP-1118

Time Frame

Day 10-11

Title

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

Time Frame

Up to 38 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Astellas Pharma Inc

Official's Role

Study Director

Facility Information:

City

Chubu

Country

Japan

City

Chugoku

Country

Japan

City

Hokkaido

Country

Japan

City

Kanto

Country

Japan

City

Kinnki

Country

Japan

City

Kyushu

Country

Japan

City

Touhoku

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

Citations:

PubMed Identifier

29934056

Citation

Mikamo H, Tateda K, Yanagihara K, Kusachi S, Takesue Y, Miki T, Oizumi Y, Gamo K, Hashimoto A, Toyoshima J, Kato K. Efficacy and safety of fidaxomicin for the treatment of Clostridioides (Clostridium) difficile infection in a randomized, double-blind, comparative Phase III study in Japan. J Infect Chemother. 2018 Sep;24(9):744-752. doi: 10.1016/j.jiac.2018.05.010. Epub 2018 Jun 19.

Results Reference

derived

Links:

URL

https://astellasclinicalstudyresults.com/study.aspx?ID=226

Description

Link to results on the Astellas Clinical Study Results website

Learn more about this trial

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

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