Clinical Trial: Budesonide Capsules Versus Mesalazine Granules in Active Ulcerative Colitis (UC)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Double-blind, Double-dummy, Randomised, Multi-centre, Comparative Phase III Clinical Study on the Efficacy and Tolerability of an 8 Week Oral Treatment With 9 mg Budesonide or 3 g Mesalazine in Patien
Brief Summary: The purpose of this study is to prove the therapeutic equivalence and safety of once-daily 9 mg budesonide versus 3 g mesalazine in a 8-week treatment in patients with active ulcerative colitis.
Detailed Summary:
Sponsor: Dr. Falk Pharma GmbH
Current Primary Outcome: Rate of clinical remission (defined by CAI <= 4, with stool frequency and rectal bleeding subscores of ´0´) at week 8 (LOCF) [ Time Frame: week 8 (LOCF) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Time to first resolution of clinical symptoms [ Time Frame: within 8 weeks ]
- CAI in the course of the study [ Time Frame: week 0, 2, 4, 6, 8 ]
- Disease Activity Index (DAI)in the course of the study [ Time Frame: week 0 and 8 (LOCF) ]
- Endoscopical Index (EI)in the course of the study [ Time Frame: week 0 and 8 (LOCF) ]
Original Secondary Outcome: Same as current
Information By: Dr. Falk Pharma GmbH
Dates:
Date Received: September 3, 2008
Date Started: October 2007
Date Completion:
Last Updated: June 25, 2012
Last Verified: June 2012
