NCT00486512

Chemoprevention of Colorectal Adenomas

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Colotech A/S · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Adenomatous Polyps

Interventions

Type	Name	Description
DRUG	0.5 mg calcitriol (1a -25-dihydroxycholecalciferol)
DRUG	75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3)
DRUG	placebo to 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol)
DRUG	placebo to 75 mg acetylsalicylic acid (ASA) + 1250 mg calcium carbonate (CaCO3)
PROCEDURE	Colonoscopy

Timeline

• Start date: 2007-06-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2007-06-14
• Last updated: 2020-09-03

Locations

39 sites across 2 countries: United States, Russia