Overview

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

Status:
Completed

Trial end date:
2013-03-18

Target enrollment:

Participant gender:

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).

Phase:

Phase 3

Details

Lead Sponsor:

Bausch Health Americas, Inc.
Valeant Pharmaceuticals International, Inc.

Treatments:

Budesonide
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents