Chemoprevention of Oral Premalignant Lesions

Phase 2CompletedNCT00036283

Pfizer42 enrolled

Overview

Reduction in size and number of oral premalignant lesions

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Precancerous Conditions

Interventions

CelecoxibDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 8mm oral premalignant lesion that has not been biopsied in the past 6 months Exclusion Criteria: * Taking \>100mg daily dose of NSAIDS (Non-steroidal anti-inflammatory drugs)

Locations (7)

Pfizer Investigational Site

Farmington, Connecticut, United States

Pfizer Investigational Site

Shreveport, Louisiana, United States

Pfizer Investigational Site

Ann Arbor, Michigan, United States

Pfizer Investigational Site

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

To evaluate the efficacy of celecoxib in subjects with Early or Advanced oral premalignant lesion (OPL)

by both clinical response (reduction in size of all lesions,

prevention of growth in the index lesion and of any new lesions)

and histological response (change in histological grade).

To evaluate the safety of chronic multiple dosing of celecoxib in this patient population.

Secondary Outcomes

To evaluate the treatment effects in modulating the expression of genomic and proliferative markers after 12 weeks of treatment with study drug, followed by 12 weeks off study drug.

Data from ClinicalTrials.gov

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