CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 84 enrolled
Drug / intervention
Zileuton +2 moredrug
Likely dose
Zileuton 1200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01021215
NCT01021215Phase 2Completed
CompareCT.gov

Modulation of Arachidonic Acid Metabolism by Chemopreventive Agents in Smokers

National Cancer Institute (NCI)·interventional·Posted Nov 26, 2009·Updated Apr 2, 2015

In Brief

A Phase 2 clinical trial evaluating Zileuton, Celecoxib, and 1 other intervention for Tobacco Use Disorder. Completed, enrolled 84 participants across 2 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTobacco Use Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 26, 2009
Enrollment StartMay 1, 2010
Primary CompletionAug 1, 2012
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.6 years ago

Interventions

Zileutondrug

1200 mg twice daily given orally (PO) for 6 days

Celecoxibdrug

200 mg twice daily given orally for 6 days

laboratory biomarker analysisother

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