Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 14, 2013
First Posted Date  ICMJE February 22, 2013
Last Update Posted Date April 4, 2017
Actual Study Start Date  ICMJE February 2013
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01796951 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Dose Aspirin Inhibition of COX-2 Derived PGE2 in Male Smokers
Official Title  ICMJE Low Dose Aspirin Inhibition of COX-2 Derived PGE2 in Male Smokers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Tobacco Use Disorder
  • Smoking
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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
Interventions:
  • Drug: Aspirin 325 mg daily
  • Drug: Celecoxib 200 mg BID
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2017)
6
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2013)
38
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 35 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01796951
Other Study ID Numbers  ICMJE VR5137
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Philip Lammers, Vanderbilt University
Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: John A Oates, MD Vanderbilt University
PRS Account Vanderbilt University Medical Center
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP