Chemoprevention of Oral Premalignant Lesions

Clinical Protocol For A Phase II Double-Blind, Placebo-Controlled, Randomized Study Of Celecoxib (Sc-58635) In Oral Premalignant Lesions, Investigator IND

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00036283

Enrollment

Registered

2002-05-09

Start date

2000-11-30

Completion date

2004-04-30

Last updated

2008-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Precancerous Conditions

Brief summary

Reduction in size and number of oral premalignant lesions

Interventions

DRUGCelecoxib

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026