Efficacy and safety of oral budesonide-MMX (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating EntocortEC

Trial Profile

Efficacy and safety of oral budesonide-MMX (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating EntocortEC

Completed
Phase of Trial: Phase III

Latest Information Update: 02 Aug 2017

At a glance

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

    • 16 Oct 2013 Pooled results presented at the 21st United European Gastroenterology Week.
    • 18 Mar 2013 Results published in Gut, according to a Santarus media release.
    • 14 Feb 2012 Actual patient number chnaged from 511 to 514 according to ClinicalTrials.gov.
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