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Comparison of Sulindac, Aspirin, and Ursodiol in Preventing Colorectal Cancer

NCT00062023 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2012-07-30

No results posted yet for this study

Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. It is not yet known whether sulindac, aspirin, or ursodiol is more effective in preventing colorectal cancer.

PURPOSE: This randomized phase II trial is studying how well sulindac works compared to aspirin or ursodiol in preventing colorectal cancer.

Conditions

Interventions

DRUG

Acetylsalicylic acid (Aspirin)

Patients receive oral aspirin once daily for 12 months.

DRUG

Sulindac

Patients receive oral sulindac twice daily for 12 months.

DRUG

Ursodiol

Patients receive oral ursodiol three times daily for 12 months.

OTHER

Sulindac Placebo

Oral sulindac placebo twice daily.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Robert S. Bresalier, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2005-04-30
Completion
2006-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00062023 on ClinicalTrials.gov