Chemoprevention of Colorectal Adenomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00486512
Recruitment Status : Terminated (Planned Interim Analysis failed to show difference between the active and placebo groups)
First Posted : June 14, 2007
Last Update Posted : February 8, 2011
Information provided by:
Colotech A/S

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Adenomatous Polyps Drug: aspirin, 1,25-dihydroxycholecalciferol, calcium Drug: placebo Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : June 2007
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium
Drug Information available for: Aspirin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
aspirin, 1,25-dihydroxycholecalciferol, calcium
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)
Placebo Comparator: 2
placebo to aspirin, 1,25-dihydroxycholecalciferol, calcium
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)

Primary Outcome Measures :
  1. cumulative frequency of recurrence of colorectal adenomas [ Time Frame: 156 weeks ]

Secondary Outcome Measures :
  1. number and size of colorectal adenomas measured after three years of using the study drug [ Time Frame: 3-5 years ]
  2. durability of treatment effect for two years post-treatment [ Time Frame: 3-5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00486512

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Sponsors and Collaborators
Colotech A/S
Study Director: Hans Raskov, M.D. Colotech A/S

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jurij Petrin, MD, Colotech A/S, Denmark Identifier: NCT00486512     History of Changes
Other Study ID Numbers: COLO CP-01-US
First Posted: June 14, 2007    Key Record Dates
Last Update Posted: February 8, 2011
Last Verified: February 2011

Keywords provided by Colotech A/S:
colorectal, adenomas, prevention

Additional relevant MeSH terms:
Adenomatous Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Calcium, Dietary
Calcium Carbonate
Bone Density Conservation Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gastrointestinal Agents
Calcium Channel Agonists
Membrane Transport Modulators