NCT00036283CompletedPhase 2
Clinical Protocol For A Phase II Double-Blind, Placebo-Controlled, Randomized Study Of Celecoxib (Sc-58635) In Oral Premalignant Lesions, Investigator IND
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 42
- Locations
- 7
- Primary Endpoint
- To evaluate the efficacy of celecoxib in subjects with Early or Advanced oral premalignant lesion (OPL)
Study Overview
Brief Summary
Reduction in size and number of oral premalignant lesions
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
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.
Investigators
Study Sites (7)
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