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.

Colotech A/S0 个研究点目标入组 1,000 人开始时间: 2005年4月22日最近更新: 2012年3月19日

研究概览

暂无简介。

•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.

发起方

Colotech A/S