NCT01598311

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 608 (actual)
• Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2012-05-16
• Primary completion: 2015-07-26
• Completion: 2015-08-25
• First posted: 2012-05-15
• Last updated: 2022-08-22
• Results posted: 2018-02-27