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