Oral Budesonide vs. Oral Mesalazine in Active Crohn's Disease (CD)
- Registration Number
- NCT00300118
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 311
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A budesonide - B mesalazine -
- Primary Outcome Measures
Name Time Method Rate of remission
- Secondary Outcome Measures
Name Time Method Response to treatment Time to response Time to remission PGA QoL
Trial Locations
- Locations (1)
Ev. Krankenhaus Hattingen GmbH
🇩🇪Hattingen, Germany