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
Sponsor: Colotech A/S
Terminated
The overall program was terminated
Listed as NCT00486512, this PHASE3 trial focuses on Adenomatous Polyps and remains terminated or withdrawn. Sponsored by Colotech A/S, it has been updated 10 times since 2007, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)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.
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.
Status Flow
Change History
10 versions recorded-
Sep 2025 — Present [monthly]
Terminated PHASE3
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Sep 2024 — Sep 2025 [monthly]
Terminated PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Terminated PHASE3
-
Apr 2022 — Jul 2024 [monthly]
Terminated PHASE3
-
Jan 2021 — Apr 2022 [monthly]
Terminated PHASE3
▶ Show 5 earlier versions
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Oct 2020 — Jan 2021 [monthly]
Terminated PHASE3
-
Mar 2019 — Oct 2020 [monthly]
Terminated PHASE3
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Jun 2018 — Mar 2019 [monthly]
Terminated PHASE3
-
Feb 2017 — Jun 2018 [monthly]
Terminated PHASE3
-
Jan 2017 — Feb 2017 [monthly]
Terminated PHASE3
First recorded
Jun 2007
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Colotech A/S
For direct contact, visit the study record on ClinicalTrials.gov .