Trial record 1 of 54 for:    oral premalignant lesions
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Chemoprevention of Oral Premalignant Lesions

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00036283
First received: May 8, 2002
Last updated: September 25, 2008
Last verified: September 2008
  Purpose

Reduction in size and number of oral premalignant lesions


Condition Intervention Phase
Precancerous Conditions
Drug: Celecoxib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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.

Estimated Enrollment: 42
Study Start Date: November 2000
Study Completion Date: April 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036283

Locations
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00036283     History of Changes
Other Study ID Numbers: NQ4-00-02-011
Study First Received: May 8, 2002
Last Updated: September 25, 2008
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 20, 2014