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 Proctitis or Proctosigmoiditis
Phase of Trial: Phase III
Latest Information Update: 19 Oct 2016
At a glance
- Drugs Budesonide (Primary)
- Indications Ulcerative proctitis; Ulcerative proctosigmoiditis
- Focus Registrational; Therapeutic Use
- Sponsors Salix Pharmaceuticals
- 08 Oct 2014 Based on results of this trial, the US FDA has granted final approval for budesonide rectal foam for the induction of remission in patients with active mild-to-moderate distal ulcerative colitis, according to a Salix Pharmaceuticals media release.
- 15 Sep 2014 Results from this trial supported US FDA tentative approval of budesonide rectal foam.
- 11 Oct 2013 Results will be presented at the American College of Gastroenterology (ACG) 2013 Annual Scientific Meeting according to a Salix Pharmaceuticals.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History