Chemoprevention of Colorectal Adenomas

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Adenomatous Polyps

In brief

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.

Key facts

Study ID

NCT00486512

Run by

Colotech A/S

People needed

350

Starts

2007-06-01

Expected to finish

2010-11-01

Last updated by the study team

2020-09-03

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• one adenoma with diameter ≥ 1 cm
• ≥ 2 adenomas of any size
• 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

You may not qualify if…

• 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

Where it is running

• Alabama Digestive Disorders Center, P.C. — Huntsville, Alabama, United States
• San Diego Digestive Disease Consultants, Inc. — San Diego, California, United States
• Advance Digestive Care — Clearwater, Florida, United States
• Internal Medicine Specialists — Orlando, Florida, United States
• Atlanta Center for Gastroenterology, PC — Decatur, Georgia, United States
• Central Indiana Gastroenterology Group — Anderson, Indiana, United States
• Gastrointestinal Clinic of Quad Cities — Davenport, Iowa, United States
• University of Kentucky Medical Center — Lexington, Kentucky, United States
• Gastroenterology Associates of Eastern Maine — Bangor, Maine, United States
• Digestive Disorders Associates — Annapolis, Maryland, United States
• Office of Alan A. Rosen, M.D. — Baltimore, Maryland, United States
• Borgess Medical Center — Kalamazoo, Michigan, United States
• Colon and Rectal Surgery Associates, Ltd. — Saint Paul, Minnesota, United States
• Digestive Health Specialists, PA — Tupelo, Mississippi, United States
• Gastroenterology Research Associates — Cedar Knolls, New Jersey, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• Wilmington Gastroenterology Associates — Wilmington, North Carolina, United States
• Digestive Health Specialists PA — Winston-Salem, North Carolina, United States
• Northwest Gastroenterology Clinic — Portland, Oregon, United States
• Regional Gastroenterology Associates of Lancaster, Ltd — Lancaster, Pennsylvania, United States
• North Texas Gastroenterology Consultants — Dallas, Texas, United States
• Alamo Medical Research — San Antonio, Texas, United States
• Advanced Healthcare, S.C. — Milwaukee, Wisconsin, United States
• Wisconsin Center for Advanced Research — Milwaukee, Wisconsin, United States
• Russian Center of Functional Surgical Gastroenterology — Krasnodar, Russia

Full record on ClinicalTrials.gov

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