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
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History