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NCT00486512 Clinical Trial

Chemoprevention of Colorectal Adenomas

Adenomatous Polyps Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00486512
Other study ID # COLO CP-01-US
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date June 2007
Est. completion date November 2010

Study information
Verified date August 2020
Source Colotech A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol)

• 75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3)

• placebo to 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol)

• placebo to 75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3)

Procedure:
• Colonoscopy

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Sponsors (1)
Lead Sponsor Collaborator
Colotech A/S

Countries where clinical trial is conducted

United States,  Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of cumulative frequency of recurrence of colorectal adenomas post ablation The purpose of the study is to investigate if long-term treatment with three known drugs (acetylsalicylic acid, 1a 25-dihydroxy cholecalciferol, and calcium carbonate) prevents recurrence of colorectal adenomas which were removed during colonoscopy. 156 weeks
Secondary Assessment of number and size of colorectal adenomas measured after three years of chemoprevention using the study drug The purpose of the study is to investigate if long-term treatment with three known drugs (acetylsalicylic acid, 1a 25-dihydroxy cholecalciferol, and calcium carbonate) prevents recurrence of colorectal adenomas which were removed during colonoscopy. 3 years
Secondary Assessment of durability of polyp-free colon post surgical ablation for two years post-treatment with chemoprevention with study drug The purpose of the study is to investigate if long-term treatment with three known drugs (acetylsalicylic acid, 1a 25-dihydroxy cholecalciferol, and calcium carbonate) prevents recurrence of colorectal adenomas which were removed during colonoscopy. additional 2 years
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