Chemoprevention of Oral Premalignant Lesions

Phase 2

Completed

• Conditions: Precancerous Conditions

• Registration Number: NCT00036283
• Lead Sponsor: Pfizer

Brief Summary

Reduction in size and number of oral premalignant lesions

Detailed Description

Not available

Study Timeline

• Study Start: 2000-11
• Study First Submitted: 2002-05-08
• Study First Submitted QC: 2002-05-08
• Study First Posted: 2002-05-09
• Study Completion: 2004-04
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-25
• Last Update Posted: 2008-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Seattle, Washington, United States