NCT01008410

Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Budesonide Foam (2 mg/25 mL BID for 2 Weeks, Followed by 2 mg/25 mL QD for 4 Weeks) Versus Placebo in Subjects With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 265 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who present with a diagnosis of active, mild to moderate, ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). During the study, eligible participants will be allowed to maintain previously established oral 5-aminosalicylic acid (5-ASA) treatment at doses up to 4.8 grams/day (g/day).

Conditions

• Proctitis
• Proctosigmoiditis

Interventions

Type	Name	Description
DRUG	Budesonide	Budesonide will be administered as per the dose and schedule specified in the respective arm.
DRUG	Placebo	Placebo matching to budesonide will be administered as per the schedule specified in the respective arm.

Timeline

• Start date: 2009-11-17
• Primary completion: 2013-04-29
• Completion: 2013-04-29
• First posted: 2009-11-05
• Last updated: 2019-08-14
• Results posted: 2019-08-14

Locations

63 sites across 1 country: United States