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
  Purpose

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 Intervention Phase
Adenomatous Polyps
Drug: aspirin, 1,25-dihydroxycholecalciferol, calcium
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Colotech A/S:

Primary Outcome Measures:
  • cumulative frequency of recurrence of colorectal adenomas [ Time Frame: 156 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1000
Study Start Date: June 2007
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00486512

  Hide Study Locations
Locations
United States, Alabama
Alabama Digestive Disorders Center, P.C.
Huntsville, Alabama, United States, 35802
United States, California
San Diego Digestive Disease Consultants, Inc.
San Diego, California, United States, 92110
United States, Florida
Advance Digestive Care
Clearwater, Florida, United States, 33756
Internal Medicine Specialists
Orlando, Florida, United States, 32806
United States, Georgia
Atlanta Center for Gastroenterology, PC
Decatur, Georgia, United States, 30033
United States, Indiana
Central Indiana Gastroenterology Group
Anderson, Indiana, United States, 46016
United States, Iowa
Gastrointestinal Clinic of Quad Cities
Davenport, Iowa, United States, 52807
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
United States, Maine
Gastroenterology Associates of Eastern Maine
Bangor, Maine, United States, 04401
United States, Maryland
Digestive Disorders Associates
Annapolis, Maryland, United States, 21401
Office of Alan A. Rosen, M.D.
Baltimore, Maryland, United States, 21215
United States, Michigan
Borgess Medical Center
Kalamazoo, Michigan, United States, 49048
United States, Minnesota
Colon and Rectal Surgery Associates, Ltd.
St. Paul, Minnesota, United States, 55114
United States, Mississippi
Digestive Health Specialists, PA
Tupelo, Mississippi, United States, 38801
United States, New Jersey
Gastroenterology Research Associates
Cedar Knolls, New Jersey, United States, 07927
United States, New York
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
Wilmington Gastroenterology Associates
Wilmington, North Carolina, United States, 28403
Digestive Health Specialists PA
Winston-Salem, North Carolina, United States, 27103
United States, Oregon
Northwest Gastroenterology Clinic
Portland, Oregon, United States, 97210
United States, Pennsylvania
Regional Gastroenterology Associates of Lancaster, Ltd
Lancaster, Pennsylvania, United States, 17604-3200
United States, Texas
North Texas Gastroenterology Consultants
Dallas, Texas, United States, 75248
Alamo Medical Research
San Antonio, Texas, United States, 78215
United States, Wisconsin
Advanced Healthcare, S.C.
Milwaukee, Wisconsin, United States, 53209
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States, 53215
Russian Federation
Russian Center of Functional Surgical Gastroenterology
Krasnodar, Russian Federation, 350086
Out-patient clinic No. 2 of the Administration for the President of Russian Federation
Moscow, Russian Federation, 119146
State Medical Stomatological University
Moscow, Russian Federation, 127473
Out-patient clinic No. 3 of the Administration for the President of Russian Federation
Moscow, Russian Federation, 129090
Federal State Enterprise "Russian Federation Defense Ministry Burdenko Main Military Clinical Hospital"
Moscow, Russian Federation, 105229
Rostov State Medical University
Rostov-on-Don, Russian Federation, 344022
Dept of Gastroenterology and Nutrition
Saint Petersburg, Russian Federation, 197110
Leningrad Regional Clinical Hospital
Saint-Petersburg, Russian Federation, 194291
Saint-Petersburg State City Hospital No 26
Saint-Petersburg, Russian Federation, 196247
Smolensk City Clinical Hospital No 1
Smolensk, Russian Federation, 214001
2nd Terapy Department Military Medical Academy
St. Petersburg, Russian Federation, 193163
All Russian Center of Emergency and Radiation Medicine of EMERCOM of Russia
St. Petersburg, Russian Federation, 194044
St. Petersburg Central Medical Sanitary Department of Federal Biological Agency
St. Petersburg, Russian Federation, 194291
Stavropol State Medical Academy
Stavropol, Russian Federation, 355017
Yaroslav City Clinical Hospital No 2
Yaroslav, Russian Federation, 150010
Sponsors and Collaborators
Colotech A/S
Investigators
Study Director: Hans Raskov, M.D. Colotech A/S
  More Information

No publications provided by Colotech A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jurij Petrin, MD, Colotech A/S, Denmark
ClinicalTrials.gov Identifier: NCT00486512     History of Changes
Other Study ID Numbers: COLO CP-01-US
Study First Received: June 12, 2007
Last Updated: February 4, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Adenoma
Adenomatous Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Aspirin
Calcitriol
Dihydroxycholecalciferols
Calcium, Dietary
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Vitamins

ClinicalTrials.gov processed this record on April 16, 2014