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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

Phase 3
40 Years
75 Years
Not Enrolling
Adenomatous Polyps

Thank you

Trial Information

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

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

cumulative frequency of recurrence of colorectal adenomas

Outcome Time Frame:

156 weeks

Safety Issue:


Principal Investigator

Hans Raskov, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Colotech A/S


United States: Food and Drug Administration

Study ID:




Start Date:

June 2007

Completion Date:

June 2012

Related Keywords:

  • Adenomatous Polyps
  • colorectal, adenomas, prevention
  • Adenoma
  • Adenomatous Polyps



Borgess Medical CenterKalamazooaa, Michigan  49001
Wisconsin Center for Advanced ResearchMilwaukee, Wisconsin  53207
University of Kentucky Medical CenterLexington, Kentucky  40536-0093
Stony Brook University Medical CenterStony Brook, New York  11794
Alamo Medical ResearchSan Antonio, Texas  78215
Alabama Digestive Disorders Center, P.C.Huntsville, Alabama  35802
San Diego Digestive Disease Consultants, Inc.San Diego, California  92110
Advance Digestive CareClearwater, Florida  33756
Internal Medicine SpecialistsOrlando, Florida  32806
Atlanta Center for Gastroenterology, PCDecatur, Georgia  30033
Central Indiana Gastroenterology GroupAnderson, Indiana  46016
Gastrointestinal Clinic of Quad CitiesDavenport, Iowa  52807
Gastroenterology Associates of Eastern MaineBangor, Maine  04401
Digestive Disorders AssociatesAnnapolis, Maryland  21401
Office of Alan A. Rosen, M.D.Baltimore, Maryland  21215
Colon and Rectal Surgery Associates, Ltd.St. Paul, Minnesota  55114
Digestive Health Specialists, PATupelo, Mississippi  38801
Gastroenterology Research AssociatesCedar Knolls, New Jersey  07927
Wilmington Gastroenterology AssociatesWilmington, North Carolina  28403
Digestive Health Specialists PAWinston-Salem, North Carolina  27103
Northwest Gastroenterology ClinicPortland, Oregon  97210
Regional Gastroenterology Associates of Lancaster, LtdLancaster, Pennsylvania  17604-3200
North Texas Gastroenterology ConsultantsDallas, Texas  75248
Advanced Healthcare, S.C.Milwaukee, Wisconsin  53209