Chemoprevention of Oral Premalignant Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00036283
Recruitment Status : Completed
First Posted : May 9, 2002
Last Update Posted : September 29, 2008
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Brief Summary:
Reduction in size and number of oral premalignant lesions

Condition or disease Intervention/treatment Phase
Precancerous Conditions Drug: Celecoxib Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 42 participants
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 : November 2000
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Primary Outcome Measures :
  1. To evaluate the efficacy of celecoxib in subjects with Early or Advanced oral premalignant lesion (OPL)
  2. by both clinical response (reduction in size of all lesions,
  3. prevention of growth in the index lesion and of any new lesions)
  4. and histological response (change in histological grade).
  5. To evaluate the safety of chronic multiple dosing of celecoxib in this patient population.

Secondary Outcome Measures :
  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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00036283

United States, Connecticut
Pfizer Investigational Site
Farmington, Connecticut, United States, 06030-3805
United States, Louisiana
Pfizer Investigational Site
Shreveport, Louisiana, United States, 71103
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Pfizer Investigational Site
Minneapolis, Minnesota, United States, 55455
United States, New York
Pfizer Investigational Site
New York, New York, United States
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98195-6607
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00036283     History of Changes
Other Study ID Numbers: NQ4-00-02-011
First Posted: May 9, 2002    Key Record Dates
Last Update Posted: September 29, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Precancerous Conditions
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents