The use of corticosteroids (Budenofalk) as a chemopreventative agent in ulcerative colitis associated neoplasia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-015077-12-GB

Enrollment

Registered

2009-09-17

Start date

2009-11-23

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

chronic ulcerative colitis

Interventions

Trade Name: Budenofalk 2mg rectal foam Product Name: Budenofalk rectal foam Pharmaceutical Form: Rectal foam

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Previous colorectal adenocarcinoma Known dysplasia in the colon Ongoing corticosteroid use Prior colonic surgical resection pregnancy Unable to give informed consent

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Identification of other biomarkers, including sFRP1, which may individually or in combination predict methylation response.;Main Objective: The primary outcome meaure is the methylation response of the Wnt antagonist sFRP1 measured as a binary variable (positive, negative); 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 ;Timepoint(s) of evaluation of this end point: -	—

Measure

Time frame

Secondary Objective: Identification of other biomarkers, including sFRP1, which may individually or in combination predict methylation response.;Main Objective: The primary outcome meaure is the methylation response of the Wnt antagonist sFRP1 measured as a binary variable (positive, negative); 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 ;Timepoint(s) of evaluation of this end point: -

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026