Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Aspirin 325 mg daily

+ Celecoxib 200 mg BID

Drug
Who is being recruted

Behavior+3

+ Mental Disorders

+ Substance-Related Disorders

From 35 to 90 Years
+24 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Early Phase 1
Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorVanderbilt University
Last updated: April 4, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01796951
Principal SponsorVanderbilt University
Last updated: April 4, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

6 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 35 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMental DisordersSubstance-Related DisordersChemically-Induced DisordersSmokingTobacco Use Disorder

Criteria

8 inclusion criteria required to participate
Ability to comply with the design of the study
Age >= 35
Baseline urine PGE-M > 13 ng/mg creatinine
Capacity to freeze urine sample at participant's residence if this participant desires to store the urine specimens in this manner
Show More Criteria
16 exclusion criteria prevent from participating
Allergy, intolerance or contraindication to aspirin or NSAID use
Current diagnosis of malignancy or history of non-skin malignancy in last 5 years
Current or recent clinically significant bleeding
Current use of systemic anticoagulants (e.g., warfarin (Coumadin), enoxaparin (Lovenox), Fondaparinux (Arixtra), dabigatran (Pradaxa))
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Celecoxib 200 mg twice daily x3 days, aspirin 325 mg daily x10 days, celecoxib 200 mb twice daily + aspirin 325 mg daily x 3 days

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Vanderbilt University

Nashville, United StatesOpen Vanderbilt University in Google Maps
CompletedOne Study Center