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NCT01021215 · ClinicalTrials.gov registry record · Phase 1
Zileuton With or Without Celecoxib As Chemopreventive Agents in Smokers
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 84
- Enrollment target
NCT01021215: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01021215 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 84 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01021215, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn how zileuton alone or the combination of zileuton and celecoxib may affect certain chemicals in the body that may be linked with a risk for smoking-related lung disease. These effects will be measured by a urine test
Primary Outcome
Pre and Post treatment differences in urinary PGE-M levels measured in each treatment arm. PGE-M levels reported as median with full range (ng/mg creatinine) for Pre treatment versus Post treatment PGE-M levels among study participants compliant to treatment with evaluable urine samples at both time points (baseline and Day 6 +/- 1 day).
Interventions
- OTHER laboratory biomarker analysis
- DRUG Celecoxib
- DRUG Zileuton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2010-05 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
What the finished NCT01021215 record still lists
NCT01021215 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher).
The record links to 0 conditions, and to 3 interventions - of which laboratory biomarker analysis is the first listed.
NCT01021215 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01021215 about?
NCT01021215 is a clinical study titled "Zileuton With or Without Celecoxib As Chemopreventive Agents in Smokers". The goal of this clinical research study is to learn how zileuton alone or the combination of zileuton and celecoxib may affect certain chemicals in the body that may be linked with a risk for smoking-related lung disease. These effects will be measured by a urine test
What is the current status of trial NCT01021215?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2010-05. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01021215?
The interventions under investigation include: laboratory biomarker analysis (OTHER), Celecoxib (DRUG), Zileuton (DRUG).
Who is sponsoring clinical trial NCT01021215?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01021215's enrollment target sits among peer trials
84 659th of 2000 higher than 1,336 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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