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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.

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609001010280
Acronym
BETA study
Enrollment
244
Registered
2009-11-23
Start date
2007-09-22
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

There are two primary objectives in this study: The primary efficacy objective is to demonstrate that the response to the treatment, measured in terms of Disease Activity Index (DAI) after 4 weeks of treatment, is not inferior in Beclomethasone Dipropionate (BDP) group, compared to the one detected in the Prednisone group. The primary safety objective is to demonstrate a better safety profile in terms of steroid toxicity and reduction of endogenous cortisol production of BDP treatment compared to Prednisone treatment.

Interventions

Beclomethasone Dipropionate (BDP) 5mg once daily (o.d.), oral tablets for first 4 weeks (from week 1 to week 4) BDP 5mg once daily (o.d.)/every other day (eod) oral tablets for second 4 weeks (from week 5 to week 8)

Sponsors

Chiesi Farmaceutici S.p.A.
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026