Patients who have had removal of polyp in colon or rectum within 3 months.
Conditions
Interventions
Product Name: Calcitriol 0.00025 mg
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: Acetylic salicylic acid 3
Sponsors
Colotech A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 • Adenomas with advanced pathological features defined as = 1cm in diameter | — |
Countries
Finland
Outcome results
None listed