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

Phase 1

• Conditions: chronic ulcerative colitis; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2009-015077-12-GB
• Lead Sponsor: niversity Hospital Birmingham NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-17
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 50

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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);<br> Primary end point(s): This is an open label phase IV randomised study.<br> 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<br> ;Timepoint(s) of evaluation of this end point: -