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Chemoprevention of Colorectal Adenomas

NCT00486512 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2020-09-03

No results posted yet for this study

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.

Conditions

  • Adenomatous Polyps

Interventions

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

Sponsors & Collaborators

  • Colotech A/S

    lead INDUSTRY

Principal Investigators

  • Hans Raskov, M.D. · Colotech A/S

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States
  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00486512 on ClinicalTrials.gov