Crohn's Disease Clinical Trial
Official title:
Double-blind, Double-dummy, Randomized, Multicentre Study to Compare the Efficacy and Safety of Oral Budesonide (9 mg) and Oral Mesalazine (4.5 g) in Moderately Active Crohn's Disease Patients
The purpose of this study is to determine whether mesalazine or budesonide is more active in the treatment of active Crohn's disease.
Crohn's disease is often treated with glucocorticoids or mesalazine. Both drugs are
indicated for active Crohn's disease. Treatment with mesalazine is indicated for the
treatment of mildly to moderately active Crohn's disease. Budesonide 9 mg/day or mesalazine
4.5 g/day are better than lower doses.
So far only one trial compares the efficacy and safety of budesonide and 5-ASA. The result
of this trial is that budesonide is more effective in inducing remission than mesalazine.
The primary objective of this trial is to confirm this result for other presentations of
budesonide and mesalazine; i.e. Budenofalk® capsules (9 mg/day) and Salofalk® tablets
(Eudragit-L-coated oral mesalazine; 4.5 g/day) in moderately active Crohn's disease.
Mesalazine is used in this trial as a comparator.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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