NCT01597505

Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-005)

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: 606 (actual)
• Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

606 participants with Clostridium Difficile Associated Diarrhea (CDAD) participated in this study and received either oral vancomycin or CB-183,315 (surotomycin) in a blinded fashion. Treatment lasted for 10 days and participants were followed up for at least 40 days and a maximum of 100 days. The purpose of this study was to evaluate how well surotomycin treats CDAD as compared to vancomycin.

Conditions

• Clostridium Difficile Infection

Interventions

Type	Name	Description
DRUG	Surotomycin	250 mg Surotomycin over-encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg, for 10 days
DRUG	Vancomycin	125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
DRUG	Placebo	Placebo for Surotomycin over-encapsulated tablet administered orally, twice daily for 10 days

Timeline

• Start date: 2012-05-16
• Primary completion: 2015-03-20
• Completion: 2015-03-20
• First posted: 2012-05-14
• Last updated: 2019-07-23
• Results posted: 2018-02-28