NCT01259726

Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of VP 20621 for Prevention of Recurrence of Clostridium Difficile Infection (CDI) in Adults Previously Treated for CDI

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are: (1) to evaluate the safety and tolerability of VP 20621 dosed orally for up to 14 days in adults previously treated for CDI; (2) to characterize the frequency and duration of stool colonization with the VP 20621 strain of C. difficile; (3) to evaluate the efficacy of VP 20621 for prevention of recurrence of CDI; and (4)to select a dose regimen of VP 20621 to be used in future studies.

Conditions

• Clostridium Difficile Infection

Interventions

Type	Name	Description
BIOLOGICAL	VP20621	VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for seven days
BIOLOGICAL	VP20621	VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days
OTHER	Placebo	10 mL placebo once daily for 14 days
BIOLOGICAL	VP20621	VP20621 as oral liquid once daily for 14 days

Timeline

• Start date: 2011-06-27
• Primary completion: 2013-06-11
• Completion: 2013-06-11
• First posted: 2010-12-14
• Last updated: 2021-06-10
• Results posted: 2015-02-12

Locations

59 sites across 6 countries: United States, Belgium, Canada, Germany, Spain, Switzerland