NCT01796951

Low Dose Aspirin Inhibition of COX-2 Derived PGE2 in Male Smokers

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: Male
• Age: 35 Years – 90 Years
• Healthy volunteers: Accepted

Summary

Regular aspirin use has been associated with a reduction in the development of a number of different malignancies including lung cancer. The mechanism of aspirin's cancer prevention is not known. This study will evaluate whether once daily aspirin use can reduce the production of a protein named prostaglandin E2 (PGE-2), which is known to promote cancer. Specifically, this study will evaluate if aspirin can inhibit the production of PGE-2 by blocking an enzyme named cycloxygenase-2 (COX-2). To accomplish these goals, participants will take either aspirin 325 mg daily, celecoxib 200 mg twice daily, or the combination of both during various days of this 16-day study. Urine be collected to evaluate for PGE-2 production at 4 timepoints in this 16-day study.

Conditions

• Tobacco Use Disorder
• Smoking

Interventions

Type	Name	Description
DRUG	Aspirin 325 mg daily	In this single-arm trial, participants will take celecoxib 200 mg BID for 5 doses, followed by aspirin 325 mg daily for 10 days, followed by combination of celecoxib 200 mg BID for 5 doses and aspirin 325 mg daily for 3 days.
DRUG	Celecoxib 200 mg BID	In this single-arm trial, participants will take celecoxib 200 mg BID for 5 doses, followed by aspirin 325 mg daily for 10 days, followed by combination of celecoxib 200 mg BID for 5 doses and aspirin 325 mg daily for 3 days.

Timeline

• Start date: 2013-02-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2013-02-22
• Last updated: 2017-04-04

Locations

1 site across 1 country: United States