A Phase 3, Open Label, Multicenter Study to Assess the Safety and Tolerability of Budesonide Foam in Subjects With Active Ulcerative Proctitis or Proctosigmoiditis.

Trial Profile

A Phase 3, Open Label, Multicenter Study to Assess the Safety and Tolerability of Budesonide Foam in Subjects With Active Ulcerative Proctitis or Proctosigmoiditis.

Completed
Phase of Trial: Phase III

Latest Information Update: 19 Oct 2016

At a glance

  • Drugs Budesonide (Primary)
  • Indications Ulcerative colitis; Ulcerative proctitis; Ulcerative proctosigmoiditis
  • Focus Adverse reactions
  • Sponsors Salix Pharmaceuticals
  • Most Recent Events

    • 26 Jan 2015 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 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.
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