At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating VP20621 and Placebo for Clostridium Difficile Infection. Completed, enrolled 173 participants across 59 sites in 6 countries.
Detailed 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.
Study Details
Timeline
Interventions
VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for seven days
VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days
10 mL placebo once daily for 14 days
VP20621 as oral liquid once daily for 14 days