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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
Not Enrolling
Both
Precancerous Conditions

Thank you

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 SiteDetroit, Michigan  48201
Pfizer Investigational SiteRochester, Minnesota  55905
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteFarmington, Connecticut  06030-3805
Pfizer Investigational SiteShreveport, Louisiana  71103