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NCT01796951 · ClinicalTrials.gov registry record · Early Phase 1
Low Dose Aspirin Inhibition of COX-2 Derived PGE2 in Male Smokers
A Early Phase 1 study, sponsored by Vanderbilt University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 6
- Enrollment target
NCT01796951: Completed Early Phase 1 study, sponsored by Vanderbilt University.
NCT01796951 is a Early Phase 1 study that has completed, run by Vanderbilt University. The registered enrollment target is 6 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01796951, a Early Phase 1 study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 6 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Aspirin 325 mg daily
- DRUG Celecoxib 200 mg BID
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2013-02 |
| Est. Completion | 2016-02 |
| Phase | Early Phase 1 |
What the finished NCT01796951 record still lists
NCT01796951 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Aspirin 325 mg daily is the first listed.
NCT01796951 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01796951 about?
NCT01796951 is a clinical study titled "Low Dose Aspirin Inhibition of COX-2 Derived PGE2 in Male Smokers". 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 pro...
What is the current status of trial NCT01796951?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 6 participants. The study started on 2013-02. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01796951?
The interventions under investigation include: Aspirin 325 mg daily (DRUG), Celecoxib 200 mg BID (DRUG).
Who is sponsoring clinical trial NCT01796951?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01796951's enrollment target sits among peer trials
6 1846th of 2000 higher than 114 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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