Clinical trial · Interventional
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
NCT00036283CI-TRIAL-00001703completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Reduction in size and number of oral premalignant lesions
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Precancerous Conditions | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Celecoxib | Drug | Celecoxib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- To evaluate the efficacy of celecoxib in subjects with Early or Advanced oral premalignant lesion (OPL)
- measure
- by both clinical response (reduction in size of all lesions,
- measure
- prevention of growth in the index lesion and of any new lesions)
- measure
- and histological response (change in histological grade).
- measure
- To evaluate the safety of chronic multiple dosing of celecoxib in this patient population.
Secondary outcomes (1)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.