OD vs. TID Dosing With Mesalazine Granules in Active Ulcerative Colitis
Phase 3
Completed
- Conditions
- Ulcerative Colitis
- Registration Number
- NCT00449722
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
To proof the therapeutic equivalence of once daily (OD) versus three times daily (TID) dosing of total 3.0 g mesalazine granules in patients with active ulcerative colitis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 380
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Rate of clinical remission
- Secondary Outcome Measures
Name Time Method rate of histological response Rate of clinical response PGA rate of endoscopical remission rate of endoscopical response rate of histological remission time to resolution of symptoms
Trial Locations
- Locations (1)
Evangelisches Krankenhaus Kalk
🇩🇪Cologne, Germany