Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Budesonide Foam Versus Placebo in Subjects With Active Mild to Moderate Ulcerative Proct
Brief Summary: The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam administered as 2mg/25mL BID for 2 weeks followed by 2mg/25mL QD for 4 weeks, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in subjects who present with a diagnosis of active, mild to moderate, ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). During the study, eligible subjects will be allowed to maintain previously established oral 5-ASA treatment at doses up to 4.8g/day.