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OpenTrials
Completed

NCT Number: NCT00036283

Chemoprevention of Oral Premalignant Lesions

Reduction in size and number of oral premalignant lesions

Completed

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Key information

Conditions

Precancerous Conditions Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Farmington, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Celecoxib

Drug

Primary outcomes

  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 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Clinical Protocol For A Phase II Double-Blind, Placebo-Controlled, Randomized Study Of Celecoxib (Sc-58635) In Oral Premalignant Lesions, Investigator IND

Important dates

Study start
2000
Study completion
2004
First posted
May 9, 2002
Registry last updated
Sep 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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