Trials / Completed
CompletedNCT00747110
Budesonide Capsules Versus Mesalazine Granules in Active Ulcerative Colitis (UC)
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 Patients With Active Ulcerative Colitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 343 (actual)
- Sponsor
- Dr. Falk Pharma GmbH · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | budesonide | 3x 3mg budesonide capsules once daily |
| DRUG | mesalazine | 3x 1000mg mesalazine onc daily |
Timeline
- Start date
- 2007-10-01
- Primary completion
- 2008-08-01
- Completion
- 2010-08-01
- First posted
- 2008-09-04
- Last updated
- 2012-06-26
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00747110. Inclusion in this directory is not an endorsement.