Randomised, Double-Blind, Multi-Centre, 12 Month Extension Study to Evaluate the Safety And Efficacy of Daily Budesonide MMX 6 mg Versus Placebo in the Maintenance of Remission in Subjects With Ulcerative Colitis.

Trial Profile

Randomised, Double-Blind, Multi-Centre, 12 Month Extension Study to Evaluate the Safety And Efficacy of Daily Budesonide MMX 6 mg Versus Placebo in the Maintenance of Remission in Subjects With Ulcerative Colitis.

Completed
Phase of Trial: Phase III

Latest Information Update: 06 Sep 2016

At a glance

  • Drugs Budesonide (Primary)
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Sponsors Salix Pharmaceuticals
  • Most Recent Events

    • 22 May 2012 Tolerability analysis assessing the effects of treatment on bone mineral density presented at Digestive Disease Week 2012.
    • 22 May 2012 Results presented at the Digestive Disease Week 2012.
    • 18 May 2012 Further analyses will be reported at the 2012 Digestive Disease Week meeting, according to a Santarus media release.
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