Clinical Trial: Efficacy and Safety of Budesonide Foam for Patients With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis

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.

Detailed Summary:

This is a Phase 3, randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of budesonide foam in subjects with active mild to moderate proctitis or proctosigmoiditis. Approximately 430 subjects will be enrolled into the study and receive either placebo foam or budesonide foam twice a day for 2 weeks followed by once a day for 4 weeks. Participation in the study will last approximately 11 weeks, depending on the timing of study visits.

During the study, eligible subjects will be allowed to maintain previously established oral 5-ASA treatment at doses up to 4.8g/day. Periodic safety monitoring, including physical examinations, vitals, laboratory testing, and recording of AEs and concomitant medications, will be performed during the study

Sponsor: Valeant Pharmaceuticals International, Inc.

Current Primary Outcome: The proportion of subjects who achieve remission. [ Time Frame: 6 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Valeant Pharmaceuticals International, Inc.

Dates:
Date Received: November 4, 2009
Date Started: November 2009
Date Completion:
Last Updated: May 17, 2013
Last Verified: November 2012