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A Randomized Study of Sulindac in Oral Premalignant Lesions

NCT00299195 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2020-11-19

Study results available
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Summary

The purpose of this study is to see if a drug called sulindac can prevent the development of changes in the mouth that are related to oral pre-cancer growths (oral epithelial dysplasia) or oral cancer. Sulindac is an anti-inflammatory drug that has already been tested in people with arthritis (inflammation of a joint).

This study is being done by Memorial Sloan-Kettering Cancer Center in New York, Amrita Institute of Medical Sciences and Research Center in Cochin, India, and Regional Cancer Centre (RCC) in Trivandrum, India.

Conditions

  • Leukoplakia, Oral
  • Benign Neoplasms

Interventions

DRUG

sulindac

Sulindac 150 mg po bid x 24 weeks

DRUG

Placebo

Placebo bid x 24 weeks

Sponsors & Collaborators

  • AIMS Institute

    collaborator OTHER

  • Weill Medical College of Cornell University

    collaborator OTHER

  • Regional Cancer Centre, Trivandrum, India

    collaborator OTHER

  • Narayana Hrudayalaya Hospitals

    collaborator OTHER

  • Memorial Sloan Kettering Cancer Center

    lead OTHER

Principal Investigators

  • Jay O. Boyle, M.D. · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-23
Primary Completion
2020-01-06
Completion
2020-01-06

Countries

  • United States
  • India

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00299195 on ClinicalTrials.gov