Status:
COMPLETED
Low Dose Aspirin Inhibition of COX-2 Derived PGE2 in Male Smokers
Lead Sponsor:
Vanderbilt University
Conditions:
Tobacco Use Disorder
Smoking
Eligibility:
MALE
35-90 years
Phase:
EARLY_PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- Male gender
- Age ≥35
- Current smoker of at least 10 cigarettes per day with history of ≥10 pack-years (py)
- Former smoker, quit no more than 15 years ago with a history of at least 25 py
- Ability to comply with the design of the study
- Capacity to freeze urine sample at participant's residence if this participant desires to store the urine specimens in this manner
- Baseline urine PGE-M \> 13 ng/mg creatinine
- Serum thromboxane \> 150 μg/L
Exclusion
- History of aspirin use 1-14 days prior to screening
- NSAID (ibuprofen, naprosyn, meloxicam, etc) use 1-7 days prior to screening
- Inhaled glucocorticoid use 1-7 days prior to screening
- Systemic glucocorticoid use 1-14 days prior to screening
- History of peptic ulcer disease
- Current or recent clinically significant bleeding
- Allergy, intolerance or contraindication to aspirin or NSAID use
- Thrombocytopenia (platelet count \< 100,000) in 30 days prior to screening visit
- Severe hepatic insufficiency
- GFR \< 30 mL/min/1.73 m2 in 30 days prior to screening visit
- History of aspirin or celecoxib allergy
- Elevated INR (\>1.5) in 30 days prior to screening visit
- Current diagnosis of malignancy or history of non-skin malignancy in last 5 years
- Current use of systemic anticoagulants (e.g., warfarin (Coumadin), enoxaparin (Lovenox), Fondaparinux (Arixtra), dabigatran (Pradaxa))
- Diagnosis of COPD
- Intake of \> 250 mg of fish oil supplementation daily
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01796951
Start Date
February 1 2013
End Date
February 1 2016
Last Update
April 4 2017
Active Locations (1)
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1
Vanderbilt University
Nashville, Tennessee, United States, 37212