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

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ClinicalTrials.gov Identifier: NCT01796951
Recruitment Status : Completed
First Posted : February 22, 2013
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Philip Lammers, Vanderbilt University

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 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.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Smoking Drug: Aspirin 325 mg daily Drug: Celecoxib 200 mg BID Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Low Dose Aspirin Inhibition of COX-2 Derived PGE2 in Male Smokers
Actual Study Start Date : February 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Celecoxib, aspirin, followed by aspirin/celecoxib
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
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.




Primary Outcome Measures :
  1. Change in COX-2 dependent urinary PGE-M (ng/mg Cr) production after 16 days of aspirin treatment [ Time Frame: 16 days ]
    Baseline urinary PGE-2 metabolite (PGE-M) will be measured. Then after 3 days of COX-2 blockade with celecoxib, it will again be measured. Participants will then undergo 10 days of treatment with aspirin and urinary PGE-M will be measured. Finally, participants will be treated with combined aspirin and celecoxib for 3 days and urinary PGE-M will be measured one last time. Using these values, the degree of aspirin inhibition of COX-2 specific urinary PGE-M production can be calculated.



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Ages Eligible for Study:   35 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01796951


Locations
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United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
Investigators
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Study Director: John A Oates, MD Vanderbilt University

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Responsible Party: Philip Lammers, Hematology/Oncology Clinical Fellow, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01796951     History of Changes
Other Study ID Numbers: VR5137
First Posted: February 22, 2013    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Aspirin
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Cyclooxygenase 2 Inhibitors