Efficacy and safety of Beclomethasone dipropionate, gastro-resistant, prolonged release tablets (CHF1514) compared to oral prednisone, in a 8-week treatment period, in patients with active ulcerative colitis. An international, multicentre, randomized, double blind, parallel group study.
Completed
- Conditions
- Mild to moderate Ulcerative colitisOral and Gastrointestinal - Inflammatory bowel disease
- Registration Number
- ACTRN12609001010280
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 244
Inclusion Criteria
Patients with active ulcerative colitis, extending proximally beyond the rectum (as verified by endoscopic examination) and with bleeding
Exclusion Criteria
Severe ulcerative colitis
Patients receiving immunomodulating and immunodepressant drugs (azathioprine, 6-mercaptopurine, methotrexate, cyclosporine), Tumor Necrosis Factor (TNF) therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients with Adverse Events (AEs) related to steroidal treatment[during the first 4 weeks of treatment (from Visit 2 to Visit 4)];Percentage of patients with clinical response, defined as a Disease Activity Index (DAI) score < 3 or reduced of at least 3 points for patients with a baseline DAI less or equal to 7[after 4 weeks of treatment with test drugs.]
- Secondary Outcome Measures
Name Time Method