ACTRN12609001010280CompletedNot Applicable
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.
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Chiesi Farmaceutici S.p.A.
- Enrollment
- 244
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to 70 Years (—)
- Sex
- All
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
Investigators
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