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Trial record 2 of 6 for:    "Colorectal Adenoma" | "Fibrinolytic Agents"

Chemoprevention of Colorectal Adenomas

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ClinicalTrials.gov Identifier: NCT00486512
Recruitment Status : Terminated (The overall program was terminated)
First Posted : June 14, 2007
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Colotech A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Adenomatous Polyps Drug: aspirin, 1,25-dihydroxycholecalciferol, calcium Drug: placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2007
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium
Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: 1
Combined use of 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
Combined use of 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)




Primary Outcome Measures :
  1. Assessment of cumulative frequency of recurrence of colorectal adenomas post ablation [ Time Frame: 156 weeks ]
    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 which were removed during colonoscopy.


Secondary Outcome Measures :
  1. Assessment of number and size of colorectal adenomas measured after three years of chemoprevention using the study drug [ Time Frame: 3 years ]
    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 which were removed during colonoscopy.

  2. Assessment of durability of polyp-free colon post surgical ablation for two years post-treatment with chemoprevention with study drug [ Time Frame: additional 2 years ]
    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 which were removed during colonoscopy.



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486512


  Show 39 Study Locations
Sponsors and Collaborators
Colotech A/S
Investigators
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Study Director: Hans Raskov, M.D. Colotech A/S

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Colotech A/S
ClinicalTrials.gov Identifier: NCT00486512     History of Changes
Other Study ID Numbers: COLO CP-01-US
First Posted: June 14, 2007    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Keywords provided by Colotech A/S:
colorectal, adenomas, prevention
Additional relevant MeSH terms:
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Fibrinolytic Agents
Adenoma
Adenomatous Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Aspirin
Calcium, Dietary
Dihydroxycholecalciferols
Calcitriol
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Vitamins
Micronutrients
Nutrients