Trial Profile
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 of Trial:
Phase III
Latest Information Update: 16 Aug 2019
Price :
$35
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At a glance
- Drugs Budesonide (Primary)
- Indications Ulcerative proctitis; Ulcerative proctosigmoiditis
- Focus Registrational; Therapeutic Use
- Sponsors Bausch Health Companies; 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.