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

Trial Profile

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

Completed
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
  • Most Recent Events

    • 11 Oct 2013 Results will be presented at the American College of Gastroenterology (ACG) 2013 Annual Scientific Meeting according to a Salix Pharmaceuticals.
    • 22 May 2013 Primary endpoint 'Significant difference between budesonide and placebo in remission rate' has been met, according to a Salix Pharmaceuticals media release.
    • 22 May 2013 Top-line results published in a Salix Pharmaceuticals media release.
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