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A Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-006)

NCT01598311 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 608

Last updated 2022-08-22

Study results available
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Summary

A total of 608 participants with Clostridium Difficile Associated Diarrhea (CDAD) will participate in this study; participants will receive either oral vancomycin or CB-183,315 in a blinded fashion. Treatment will last for 10 days and participants will be followed up for at least 40 days and a maximum of 100 days. The purpose of this study is to evaluate how well CB-183,315 treats CDAD as compared to vancomycin.

Conditions

  • Clostridium Difficile Infection

Interventions

DRUG

CB-183,315

CB-183,315 250 mg white coated tablet over-encapsulated in a size 00 opaque hard gelatin capsule.

DRUG

Vancomycin

Vancomycin hydrochloride 125 mg capsule over-encapsulated in size 00 opaque hard gelatin capsule.

DRUG

Placebo

Placebo size 00 opaque hard gelatin capsules.

Sponsors & Collaborators

  • Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-16
Primary Completion
2015-07-26
Completion
2015-08-25

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01598311 on ClinicalTrials.gov