Clinical Trial: Chemoprevention of Colorectal Adenomas
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
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
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.
Detailed Summary: 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.
Sponsor: Colotech A/S
Current Primary Outcome: cumulative frequency of recurrence of colorectal adenomas [ Time Frame: 156 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- number and size of colorectal adenomas measured after three years of using the study drug [ Time Frame: 3-5 years ]
- durability of treatment effect for two years post-treatment [ Time Frame: 3-5 years ]
Original Secondary Outcome: Same as current
Information By: Colotech A/S
Dates:
Date Received: June 12, 2007
Date Started: June 2007
Date Completion: June 2012
Last Updated: February 4, 2011
Last Verified: February 2011
