Clinical Protocol For A Phase II Double-Blind, Placebo-Controlled, Randomized Study Of Celecoxib (Sc-58635) In Oral Premalignant Lesions, Investigator IND
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Precancerous Conditions
Both
Precancerous Conditions
Trial Information
Clinical Protocol For A Phase II Double-Blind, Placebo-Controlled, Randomized Study Of Celecoxib (Sc-58635) In Oral Premalignant Lesions, Investigator IND
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Outcome Measure:
To evaluate the efficacy of celecoxib in subjects with Early or Advanced oral premalignant lesion (OPL)
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
NQ4-00-02-011
NCT ID:
NCT00036283
Start Date:
November 2000
Completion Date:
April 2004
Related Keywords:
- Precancerous Conditions
- Precancerous Conditions
Name | Location |
|---|---|
| Pfizer Investigational Site | Detroit, Michigan 48201 |
| Pfizer Investigational Site | Rochester, Minnesota 55905 |
| Pfizer Investigational Site | Bronx, New York 10461 |
| Pfizer Investigational Site | Houston, Texas 77030 |
| Pfizer Investigational Site | Federal Way, Washington 98003 |
| Pfizer Investigational Site | Farmington, Connecticut 06030-3805 |
| Pfizer Investigational Site | Shreveport, Louisiana 71103 |
