Chemoprevention of Colorectal Adenomas - Full Text View

Sponsored by:	Colotech A/S
Information provided by:	Colotech A/S
ClinicalTrials.gov Identifier:	NCT00486512

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 III

MedlinePlus related topics: Calcium

Drug Information available for: Calcium gluconate Calcium carbonate Cholecalciferol Calcitriol Acetylsalicylic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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
1: Experimental 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)
2: Placebo Comparator 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

Contacts

Contact: Gabriele Heiles

610.933.6559

gabriele.heiles@prs-clinical.com

Show 43 Study Locations

Sponsors and Collaborators

Colotech A/S

Investigators

Study Director:

Hans Raskov, M.D.

Colotech A/S

More Information

Responsible Party:	Colotech A/S, Denmark ( Jurij Petrin, MD )
Study ID Numbers:	COLO CP-01-US
Study First Received:	June 12, 2007
Last Updated:	December 30, 2008
ClinicalTrials.gov Identifier:	NCT00486512
Health Authority:	United States: Food and Drug Administration

Keywords provided by Colotech A/S:

colorectal, adenomas, prevention

Study placed in the following topic categories:

Calcium, Dietary
Cholecalciferol
Aspirin
Polyps
Calcium Carbonate
Dihydroxycholecalciferols

Adenoma
Recurrence
Adenomatous Polyps
Calcitriol
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Calcium Channel Agonists
Bone Density Conservation Agents
Cardiovascular Agents

Pharmacologic Actions
Membrane Transport Modulators
Neoplasms
Therapeutic Uses
Vitamins
Vasoconstrictor Agents
Micronutrients

ClinicalTrials.gov processed this record on January 16, 2009