Tobacco Use DisorderEarly Phase 1NCT01796951
Low Dose Aspirin Inhibition of COX-2 Derived PGE2 in Male Smokers
A Early Phase 1 study testing Aspirin 325 mg daily and Celecoxib 200 mg BID in people with Tobacco Use Disorder and Smoking, run by Vanderbilt University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder, Smoking
- What is being tested?
- Aspirin 325 mg daily and Celecoxib 200 mg BID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Feb 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Tobacco Use Disorder, Smoking
- Being tested
- Aspirin 325 mg daily, Celecoxib 200 mg BID
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 325 mg dailyDrug
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.
Celecoxib 200 mg BIDDrug
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 group | Role | What they receive |
|---|---|---|
| Celecoxib, aspirin, followed by aspirin/celecoxib | 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 Receives: Drug: Aspirin 325 mg daily; Drug: Celecoxib 200 mg BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in COX-2 dependent urinary PGE-M (ng/mg Cr) production after 16 days of aspirin treatment
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.
Measured: 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Lammers, Vanderbilt University
- Investigators
- John A Oates, MD, Study director, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796951
- Sponsor's protocol ID
- VR5137
- Status last verified
- Mar 2017
- First submitted
- 14 Feb 2013
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Aspirin Inhibition of COX-2 Derived PGE2 in Male Smokers
- ClinicalTrials.gov ID
- NCT01796951
- Acronym / sponsor ID
- VR5137
- Conditions
- Tobacco Use Disorder, Smoking
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 22 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Celecoxib, aspirin, followed by aspirin/celecoxib | Experimental | Drug: Aspirin 325 mg daily, Drug: Celecoxib 200 mg BIDCelecoxib 200 mg twice daily x3 days, aspirin 325 mg daily x10 days, celecoxib 200 mb twice daily + aspirin 325 mg daily x 3 days |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin 325 mg dailyIn 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, aspirin, followed by aspirin/celecoxib |
| Celecoxib 200 mg BIDIn 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, aspirin, followed by aspirin/celecoxib |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Oates, MD study director
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Aspirin 325 mg daily and Celecoxib 200 mg BID in people with Tobacco Use Disorder and Smoking, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in COX-2 dependent urinary PGE-M (ng/mg Cr) production after 16 days of aspirin treatment (time frame: 16 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.