Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT01796951
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
35 Years
Maximum Age:
90 Years
Study:
NCT01796951
Study Brief:
Protocol Section:
NCT01796951