Efficacy and Safety of New Oral Budesonide-MMX (CB-01-02) 6 mg and 9 mg Extended Release Tablet Formulations in Patients With Mild or Moderate, Active Ulcerative Colitis. A Multicenter, Randomized, Double-Blind, Double Dummy Comparative Study Versus Placebo, With an Additional Reference Arm Evaluating Asacol 2400 mg

Trial Profile

Efficacy and Safety of New Oral Budesonide-MMX (CB-01-02) 6 mg and 9 mg Extended Release Tablet Formulations in Patients With Mild or Moderate, Active Ulcerative Colitis. A Multicenter, Randomized, Double-Blind, Double Dummy Comparative Study Versus Placebo, With an Additional Reference Arm Evaluating Asacol 2400 mg

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Aug 2016

At a glance

  • Drugs Budesonide (Primary) ; Mesalazine
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms CORE-1
  • Sponsors Salix Pharmaceuticals
  • Most Recent Events

    • 16 Oct 2013 Pooled results presented at the 21st United European Gastroenterology Week.
    • 26 Oct 2011 Results presented at the 19th United European Gastroenterology Week.
    • 30 Aug 2011 Additional trial sponsor (Ajanta Pharma) added as reported by Clinical Trials Registry - India record.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top