An international, multi centre, randomised, parallel group, prospective, double blind, placebo controlled clinical trial evaluating the efficacy and safety of a combination treatment administered over 3 years in patients at risk of experiencing recurrence of colorectal adenomas.
- Conditions
- Patients who have had removal of polyp in colon or rectum within 3 months.
- Registration Number
- EUCTR2004-000693-31-FI
- Lead Sponsor
- Colotech A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1000
•Signed informed consent
•Patients 40-75 years of age, both sexes.
•Willingness to desist to all use of NSAIDs for the duration of the trial (preferred alternative is Paracetamol)
•Colonoscopy including the caecum at trial entry (start of the placebo-run-in-period) or within the last 3 month prior to this date with removal of one or more adenoma(s). If piece meal resection has been used for removal of the adenoma(s), a control endoscopy has to be performed to confirm complete removal (clean” colon) at trial entry, i.e. maximum 3 months after the piece meal resection procedure.
•The removed adenoma(s) have be to tubular, tubulovillous or villous, and fulfil one of the three following criteria:
1)one adenoma with diameter ? 1 cm
2)? 2 adenomas of any size
3)an adenoma of any size and familial disposition for colorectal cancer, as long as the person is a first degree relative with a colorectal cancer patient
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) yes
F.1.3.1 Number of subjects for this age range
•Familial Adenomatous Polyposis Syndrome
(FAP: diagnosed as > 100 colorectal adenomas or DNA analysis).
•Member of a family with hereditary non-polyposis colorectal cancer (HNPCC) diagnosed according to the Amsterdam Criteria or as a result of a proven mis-match repair-gene defect.
•Proctocolectomy (colonic and/or rectum resection permitted).
•Inflammatory bowel disease (Crohn´s disease, Ulcerative Colitis).
•Ischaemic cardiovascular disease.
(current or expected treatment with any Cox inhibitor, incl. ASA).
•Patients with known gastro-duodenal ulcer at time of inclusion.
•Cancer within the past 5 years
(non-melanoma skin cancer and carcinoma in situ cervix uteri permitted).
•Uncontrolled hypertension despite treatment
(diastolic >100 mmHg, systolic >180 mmHg).
•Known medical history of urinary stone disease which in the opinion of the Investigator could be a problem in connection with the intake of Calcitriol.
•Pregnancy.
•Severe liver and/or kidney insufficiency.
•Bleeding diathesis.
•Anticoagulant treatment.
•Chronic NSAID treatment (i.e. daily use for more than 3 months prior to inclusion).
•Current or expected treatment with Cyclosporine A.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate that chemoprophylaxis with the IMPs will decrease recurrency rate for colo-rectal polyps when observed for a 3-year period.;Secondary Objective: To investigate the safety of long term treatment with the IMPs;Primary end point(s): •All adenomas detected at colonoscopy after 3 years of treatment<br>•Adenomas with advanced pathological features defined as = 1cm in diameter
- Secondary Outcome Measures
Name Time Method