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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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30 June 2019 |
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Main ID: |
EUCTR2009-015077-12-GB |
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Date of registration:
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17/09/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The use of corticosteroids (Budenofalk) as a chemopreventative agent in ulcerative colitis associated neoplasia
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Scientific title:
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The use of corticosteroids (Budenofalk) as a chemopreventative agent in ulcerative colitis associated neoplasia |
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Date of first enrolment:
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23/11/2009 |
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Target sample size:
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50 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-015077-12 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: no treatment
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Symptimatic ulcerative pan-colitis (affecting the colon to at least the hepatic flexure) for more than 10 years
On active ulcerative colitis surveillance colonoscopy programme
Age 20-75
Cortico-steroid naive (topical and systemic) for 6 months
Able to give informed consent
May be on miantenence 5ASA or immunosuppressant treatment which will be continued
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Previous colorectal adenocarcinoma
Known dysplasia in the colon
Ongoing corticosteroid use
Prior colonic surgical resection
pregnancy
Unable to give informed consent
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
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chronic ulcerative colitis
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Intervention(s)
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Trade Name: Budenofalk 2mg rectal foam
Product Name: Budenofalk rectal foam
Pharmaceutical Form: Rectal foam
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Primary Outcome(s)
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Primary end point(s): This is an open label phase IV randomised study.
In this study 50 patients will be randomised between Budenofalk 2mg (Group A) per day for 4 weeks and no intervention (Group B); 25 patients in each group. After 4 and 8 weeks, patients will undergo repeat bowel examination to assess the effect of the treatment on the expression of the chosen epithelial markers of colorectal cancer risk
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Secondary Objective: Identification of other biomarkers, including sFRP1, which may individually or in combination predict methylation response.
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Timepoint(s) of evaluation of this end point: -
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Main Objective: The primary outcome meaure is the methylation response of the Wnt antagonist sFRP1 measured as a binary variable (positive, negative)
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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