Chemoprevention of Colorectal Adenomas

This study has been terminated.
(Planned Interim Analysis failed to show difference between the active and placebo groups)
Sponsor:
Information provided by:
Colotech A/S
ClinicalTrials.gov Identifier:
NCT00486512
First received: June 12, 2007
Last updated: February 4, 2011
Last verified: February 2011

June 12, 2007
February 4, 2011
June 2007
June 2012   (final data collection date for primary outcome measure)
cumulative frequency of recurrence of colorectal adenomas [ Time Frame: 156 weeks ] [ Designated as safety issue: No ]
cumulative frequency of recurrence of colorectal adenomas [ Time Frame: 156 weeks ]
Complete list of historical versions of study NCT00486512 on ClinicalTrials.gov Archive Site
  • number and size of colorectal adenomas measured after three years of using the study drug [ Time Frame: 3-5 years ] [ Designated as safety issue: No ]
  • durability of treatment effect for two years post-treatment [ Time Frame: 3-5 years ] [ Designated as safety issue: No ]
  • number and size of colorectal adenomas measured after three years of using the study drug [ Time Frame: 3-5 years ]
  • durability of treatment effect for two years post-treatment [ Time Frame: 3-5 years ]
Not Provided
Not Provided
 
Chemoprevention of Colorectal Adenomas
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Adenomatous Polyps
  • 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)
  • Experimental: 1
    aspirin, 1,25-dihydroxycholecalciferol, calcium
    Intervention: Drug: aspirin, 1,25-dihydroxycholecalciferol, calcium
  • Placebo Comparator: 2
    placebo to aspirin, 1,25-dihydroxycholecalciferol, calcium
    Intervention: Drug: placebo
Carroll C, Cooper K, Papaioannou D, Hind D, Pilgrim H, Tappenden P. Supplemental calcium in the chemoprevention of colorectal cancer: a systematic review and meta-analysis. Clin Ther. 2010 May;32(5):789-803.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1000
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Russian Federation
 
NCT00486512
COLO CP-01-US
No
Jurij Petrin, MD, Colotech A/S, Denmark
Colotech A/S
Not Provided
Study Director: Hans Raskov, M.D. Colotech A/S
Colotech A/S
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP