Back to resultsChemoprevention of Oral Premalignant Lesions
Primary Purpose
Precancerous Conditions
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Celecoxib
Sponsored by
About this trial
This is an interventional prevention trial for Precancerous Conditions
Eligibility Criteria
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)
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00036283
Brief Title
Chemoprevention of Oral Premalignant Lesions
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 Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
November 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
Reduction in size and number of oral premalignant lesions
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Precancerous Conditions
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
42 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Primary Outcome Measure Information:
Title
To evaluate the efficacy of celecoxib in subjects with Early or Advanced oral premalignant lesion (OPL)
Title
by both clinical response (reduction in size of all lesions,
Title
prevention of growth in the index lesion and of any new lesions)
Title
and histological response (change in histological grade).
Title
To evaluate the safety of chronic multiple dosing of celecoxib in this patient population.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-3805
Country
United States
Facility Name
Pfizer Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Pfizer Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Pfizer Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6607
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=NQ4-00-02-011&StudyName=Chemoprevention+of+Oral+Premalignant+Lesions
Description
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Learn more about this trial
Chemoprevention of Oral Premalignant Lesions
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