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Trial registered on ANZCTR


Registration number
ACTRN12609001010280
Ethics application status
Approved
Date submitted
17/11/2009
Date registered
23/11/2009
Date last updated
23/11/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Universal Trial Number (UTN)
Trial acronym
BETA study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild to moderate Ulcerative colitis 252181 0
Condition category
Condition code
Oral and Gastrointestinal 252379 252379 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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)
Intervention code [1] 241540 0
Treatment: Drugs
Comparator / control treatment
Prednisone 40mg once daily (o.d.) oral tablets for 2 weeks (week 1 to week 2)

Prednisone 30mg once daily (o.d.) oral tablets for 2 weeks (week 3 to week 4)

Prednisone 20mg once daily (o.d.) oral tablets for 2 weeks (week 5 to week 6)

Prednisone 10mg once daily (o.d.) oral tablets for 2 weeks (week 7 to week 8)
Control group
Active

Outcomes
Primary outcome [1] 253252 0
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
Timepoint [1] 253252 0
after 4 weeks of treatment with test drugs.
Primary outcome [2] 253253 0
Percentage of patients with Adverse Events (AEs) related to steroidal treatment
Timepoint [2] 253253 0
during the first 4 weeks of treatment (from Visit 2 to Visit 4)
Secondary outcome [1] 262224 0
Percentage of patients with clinical response after 4 weeks of treatment without steroid-related adverse events (AEs)
Timepoint [1] 262224 0
after 8 weeks of treatment with test drugs
Secondary outcome [2] 262225 0
Percentage of patients with a Disease Activity Index (DAI) score less than or equal to 1
Timepoint [2] 262225 0
after 4 weeks of treatment with test drugs.
Secondary outcome [3] 262226 0
Change in Disease Activity Index (DAI) total score after 4 weeks of treatment;
Timepoint [3] 262226 0
after 4 weeks of treatment with test drugs.
Secondary outcome [4] 262227 0
Change in endoscopic score
Timepoint [4] 262227 0
after 4 weeks of treatment with test drugs.
Secondary outcome [5] 262228 0
Change in Clinical Activity Index (CAI) total score
Timepoint [5] 262228 0
after 4 and 8 weeks of treatment with test drugs.
Secondary outcome [6] 262229 0
Change in bleeding score as defined in the DAI (rectal bleeding) and CAI (blood in stools) score questionnaire
Timepoint [6] 262229 0
after 4 and 8 weeks of treatment with test drugs.
Secondary outcome [7] 262230 0
Changes in C-reactive protein (CRP) and Erythrocytes Sedimentation Rate (ESR)
Timepoint [7] 262230 0
after 4 and 8 weeks of treatment with test drugs.
Secondary outcome [8] 262231 0
Percentage of patients with Adverse Events (AEs) related to steroid treatment
Timepoint [8] 262231 0
during the second 4 weeks of treatment (after Visit 4 to Visit 6)
Secondary outcome [9] 262232 0
Changes from baseline to visits in morning cortisol level (blood sample for centralized laboratory analysis)
Timepoint [9] 262232 0
after 4 and 8 weeks of treatment
Secondary outcome [10] 262233 0
Changes from baseline to visits in laboratory test parameters (HAEMATOLOGY, BLOOD CHEMISTRY AND URINE CHEMISTRY);
Timepoint [10] 262233 0
after 4 and 8 weeks of treatment
Secondary outcome [11] 262234 0
Change from baseline to visit 4 and 6 in vital signs (SITTING BLOOD PRESSURE, SITTING HEART RATE, Body temperature (C) assessments);
Timepoint [11] 262234 0
after 4 and 8 weeks of treatment

Eligibility
Key inclusion criteria
Patients with active ulcerative colitis, extending proximally beyond the rectum (as verified by endoscopic examination) and with bleeding
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe ulcerative colitis
Patients receiving immunomodulating and immunodepressant drugs (azathioprine, 6-mercaptopurine, methotrexate, cyclosporine), Tumor Necrosis Factor (TNF) therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
244
Accrual to date
Final
Recruitment outside Australia
Country [1] 2324 0
Italy
State/province [1] 2324 0
Country [2] 2325 0
Spain
State/province [2] 2325 0
Country [3] 2326 0
Belgium
State/province [3] 2326 0
Country [4] 2327 0
Romania
State/province [4] 2327 0
Country [5] 2328 0
Russian Federation
State/province [5] 2328 0
Country [6] 2329 0
Poland
State/province [6] 2329 0
Country [7] 2330 0
Ukraine
State/province [7] 2330 0

Funding & Sponsors
Funding source category [1] 244009 0
Commercial sector/Industry
Name [1] 244009 0
Chiesi Farmaceutici S.p.A.
Country [1] 244009 0
Italy
Primary sponsor type
Commercial sector/Industry
Name
Chiesi Farmaceutici S.p.A.
Address
Via Palermo, 26/A
43122 Parma
Country
Italy
Secondary sponsor category [1] 251360 0
None
Name [1] 251360 0
NA
Address [1] 251360 0
NA
Country [1] 251360 0

Ethics approval
Ethics application status
Approved

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30501 0
Address 30501 0
Country 30501 0
Phone 30501 0
Fax 30501 0
Email 30501 0
Contact person for public queries
Name 13748 0
Marco Zibellini
Address 13748 0
Via Palermo, 26/A
43122 Parma
Country 13748 0
Italy
Phone 13748 0
+ 39 0521 279713
Fax 13748 0
+ 39 0521 279333
Email 13748 0
[email protected]
Contact person for scientific queries
Name 4676 0
Marco Zibellini
Address 4676 0
Via Palermo, 26/A
43122 Parma
Country 4676 0
Italy
Phone 4676 0
+ 39 0521 279713
Fax 4676 0
+ 39 0521 279333
Email 4676 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseOral prolonged release beclomethasone dipropionate and prednisone in the treatment of active ulcerative colitis: Results from a double-blind, randomized, parallel group study.2015https://dx.doi.org/10.1038/ajg.2015.114
N.B. These documents automatically identified may not have been verified by the study sponsor.