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
1 other identifier
interventional
42
1 country
7
Brief Summary
Reduction in size and number of oral premalignant lesions
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2000
Typical duration for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2000
CompletedFirst Submitted
Initial submission to the registry
May 8, 2002
CompletedFirst Posted
Study publicly available on registry
May 9, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2004
CompletedSeptember 29, 2008
September 1, 2008
May 8, 2002
September 25, 2008
Conditions
Outcome Measures
Primary Outcomes (5)
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 (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- mm oral premalignant lesion that has not been biopsied in the past 6 months
You may not qualify if:
- Taking \>100mg daily dose of NSAIDS (Non-steroidal anti-inflammatory drugs)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (7)
Pfizer Investigational Site
Farmington, Connecticut, 06030-3805, United States
Pfizer Investigational Site
Shreveport, Louisiana, 71103, United States
Pfizer Investigational Site
Ann Arbor, Michigan, 48109, United States
Pfizer Investigational Site
Minneapolis, Minnesota, 55455, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Houston, Texas, 77030, United States
Pfizer Investigational Site
Seattle, Washington, 98195-6607, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 8, 2002
First Posted
May 9, 2002
Study Start
November 1, 2000
Study Completion
April 1, 2004
Last Updated
September 29, 2008
Record last verified: 2008-09