NCT00300118

Oral Budesonide vs. Oral Mesalazine in Active Crohn's Disease (CD)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 311 (actual)
• Sponsor: Dr. Falk Pharma GmbH · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether mesalazine or budesonide is more active in the treatment of active Crohn's disease.

Detailed description

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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	budesonide	9 mg
DRUG	mesalazine	4.5 g

Timeline

• Start date: 2004-09-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2006-03-08
• Last updated: 2014-05-19

Locations

1 site across 1 country: Germany