Official Title: “A 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”

The purpose of the study is to investigate if long-term treatment with three known drugs (acetylsalicylic acid, 1α 25-dihydroxy cholecalciferol, and calcium carbonate) prevents recurrence of colorectal adenomas.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2012

This is a multicenter, randomized, parallel group, prospective, double blind, placebo controlled clinical trial of chemoprevention in patients at increased risk of developing colorectal cancer (CRC). The Colotech combination treatment (acetylsalicylic acid, 1α 25-dihydroxy cholecalciferol, and calcium carbonate) will be compared to placebo with regards to safety and efficacy during 3 years of treatment. The randomized treatment period will be preceded by a 3-week single blind placebo run-in period, which will assess patient's compliance to treatment. In order to collect data on the durability of treatment effect, follow-up data from a surveillance colonoscopy will be collected two years after the 3-year colonoscopy.

Intervention(s) in this Clinical Trial

• Drug: aspirin, 1,25-dihydroxycholecalciferol, calcium
  • Oral Calcitriol (1α 25-dihydroxy cholecalciferol) capsules, 0.5 µg (QD) Oral acetylsalicylic acid 37.5 mg and calcium carbonate 625 mg combination tablets (bid)
• Drug: placebo
  • placebo to oral Calcitriol (1α 25-dihydroxy cholecalciferol) capsules, 0.5 µg (QD) placebo to oral acetylsalicylic acid 37.5 mg and calcium carbonate 625 mg combination tablets (bid)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • aspirin, 1,25-dihydroxycholecalciferol, calcium
• Placebo Comparator: 2
  • placebo to aspirin, 1,25-dihydroxycholecalciferol, calcium

Primary Measures

• cumulative frequency of recurrence of colorectal adenomas
  • Time Frame: 156 weeks
    Safety Issue?: No

Secondary Measures

• number and size of colorectal adenomas measured after three years of using the study drug
  • Time Frame: 3-5 years
    Safety Issue?: No
• durability of treatment effect for two years post-treatment
  • Time Frame: 3-5 years
    Safety Issue?: No

Inclusion Criteria:

• Patients 40-75 years of age, both sexes.
• Colonoscopy including the cecum at trial entry
• The removed adenoma(s) have be to tubular, tubulovillous or villous, and fulfill 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

Exclusion Criteria:

• Familial Adenomatous Polyposis Syndrome
• Member of a family with hereditary non-polyposis colorectal cancer (HNPCC)
• Proctocolectomy (colonic and/or rectum resection permitted).
• Inflammatory bowel disease (Crohn´s disease, Ulcerative Colitis).
• Ischemic cardiovascular disease.
• Patients with known gastro-duodenal ulcer at time of inclusion.
• Cancer within the past 5 years

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Colotech A/S

Overall Clinical Trial Officials and Contacts

Hans Raskov, M.D. Study Director Colotech A/S  

Overall Contact: Gabriele Heiles 610.933.6559 gabriele.heiles@prs-clinical.com

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00486512

Study ID Number: COLO CP-01-US

ClinicalTrials.gov Identifier: NCT00486512

Health Authority: United States: Food and Drug Administration