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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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)

NCT02179658•Astellas Pharma Inc

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - No limit years

Sex

ALL

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
+4 more criteria

Locations (7)

Chugoku, Japan

Chūbu, Japan

Hokkaido, Japan

Kanto, Japan

Kinnki, Japan

Kyushu, Japan

Tōhoku, Japan

Key Dates

Start Date

June 23, 2014

Primary Completion Date

September 8, 2016

Completion Date

September 8, 2016

Last Updated

October 31, 2024

Enrollment

210

ACTUAL participants

Conditions

Clostridium Difficile

Interventions

OPT-80

DRUG

vancomycin

DRUG

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

NCT06237452

Clostridium DifficileClostridium Difficile Infections+8 more

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RECRUITINGNA

Advantages and Disadvantages of TOXCLEAN As Add on Treatment to SOC in Patients with Clostridium Difficile-associated Diarrhea

NCT06839209

Clostridium; Difficile, As Cause of Disease Classified ElsewhereClostridium Difficile Diarrhea

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 31, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Advantages and Disadvantages of TOXCLEAN As Add on Treatment to SOC in Patients with Clostridium Difficile-associated Diarrhea

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