Chemoprevention of Oral Premalignant Lesions
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00036283
Collaborator
(none)
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Study Details
Study Description
Brief Summary
Reduction in size and number of oral premalignant lesions
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Prevention
Official Title:
Clinical Protocol For A Phase II Double-Blind, Placebo-Controlled, Randomized Study Of Celecoxib (Sc-58635) In Oral Premalignant Lesions, Investigator IND
Study Start Date
:
Nov 1, 2000
Actual Study Completion Date
:
Apr 1, 2004
Outcome Measures
Primary Outcome Measures
- 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
- 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 Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Farmington | Connecticut | United States | 06030-3805 |
| 2 | Pfizer Investigational Site | Shreveport | Louisiana | United States | 71103 |
| 3 | Pfizer Investigational Site | Ann Arbor | Michigan | United States | 48109 |
| 4 | Pfizer Investigational Site | Minneapolis | Minnesota | United States | 55455 |
| 5 | Pfizer Investigational Site | New York | New York | United States | |
| 6 | Pfizer Investigational Site | Houston | Texas | United States | 77030 |
| 7 | Pfizer Investigational Site | Seattle | Washington | United States | 98195-6607 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00036283
Other Study ID Numbers:
- NQ4-00-02-011
First Posted:
May 9, 2002
Last Update Posted:
Sep 29, 2008
Last Verified:
Sep 1, 2008