CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 608 enrolled
Drug / intervention
CB-183,315 +2 moredrug
Likely dose
CB-183,315 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01598311
NCT01598311Phase 3Completed
CompareCT.gov

A Randomized, Double-Blinded, Active-Controlled Study of CB-183,315 in Patients With Clostridium Difficile Associated Diarrhea

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted May 15, 2012·Updated Aug 22, 2022

In Brief

A Phase 3 clinical trial evaluating CB-183,315, Vancomycin, and 1 other intervention for Clostridium Difficile Infection. Completed, enrolled 608 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClostridium Difficile Infection
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 15, 2012
Enrollment StartMay 16, 2012
Primary CompletionJul 26, 2015
Study CompletionAug 25, 2015
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 14.1 years ago

Interventions

CB-183,315drug

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

Vancomycindrug

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

Placebodrug

Placebo size 00 opaque hard gelatin capsules.