Trial · NCT01021215
Zileuton With or Without Celecoxib As Chemopreventive Agents in Smokers
NCT01021215, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2015-04-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Zileuton With or Without Celecoxib As Chemopreventive Agents in Smokers. Trials, record NCT01021215. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01021215
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Zileuton With or Without Celecoxib As Chemopreventive Agents in Smokers
- NCT number
- NCT01021215
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 84 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Tobacco Use Disorder
- Interventions
- Zileuton, Celecoxib, laboratory biomarker analysis
- First posted
- 2009-11-26
- Last updated
- 2015-04-02
- Results first posted
- 2015-04-02
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Urinary PGE-M Levels (Pre and Post Treatment) | Baseline and Day 6 | 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). |
| Primary | Median Urinary LTE4 Levels (Pre and Post Treatment) | Baseline and day 6 | Pre and Post treatment differences in urinary LTE4 levels measured in each treatment arm compared using paired t-test should the data conform to the normality assumption or one-sample Wilcoxon rank-sum test. LTE4 levels reported as median with full range (pg/mg creatinine) for Pre treatment versus Post treatment LTE4 levels among study participants compliant to treatment with evaluable urine samples at both time points (baseline and Day 6 +/- 1 day). |
| Secondary | Proportion of Cases With a Post-treatment Increase in Urinary PGE-M Levels | Baseline to Day 6 | Proportion of cases with a post-treatment increase in urinary PGE-M levels by comparing those treated with Zileuton and Celecoxib combined therapy compared to those treated with Zileuton alone. Pre/postchange in levels (Increase) derived from baseline level to Day 6 +/- 1 day. Differences in baseline levels between 2 treatment arms were examined using the Wilcoxon rank-sum test. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Urinary PGE-M Levels (Pre and Post Treatment) | Baseline and Day 6 | Seventy-seven subjects completed the entire study with seven of those excluded from analysis as non-compliant (study medications were undetectable). Urine of two participants contained interfering substances thus were excluded from PGE-M related analysis. | ng/mg creatinine | MEDIAN |
| PRIMARY | Median Urinary LTE4 Levels (Pre and Post Treatment) | Baseline and day 6 | Seventy-seven subjects completed the entire study, three withdrew for personal reasons. Seven of those participants were excluded from analysis as non-compliant (study medications were undetectable). | pg/mg creatinine | MEDIAN |
| SECONDARY | Proportion of Cases With a Post-treatment Increase in Urinary PGE-M Levels | Baseline to Day 6 | Analysis includes only number of participants in each treatment arm with post-treatment increase in urinary PGE-M levels as measured from baseline. | proportion of participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Urinary PGE-M Levels (Pre and Post Treatment) | Arm I: Zileuton | Pre PGE-M Levels | 12.8 | Full Range 1.4 to 50.4 | ng/mg creatinine |
| Median Urinary PGE-M Levels (Pre and Post Treatment) | Arm II: Zileuton and Celecoxib | Pre PGE-M Levels | 13.4 | Full Range 2.3 to 35.1 | ng/mg creatinine |
| Median Urinary PGE-M Levels (Pre and Post Treatment) | Arm I: Zileuton | Post PGE-M Levels | 10.5 | Full Range 2.0 to 34.6 | ng/mg creatinine |
| Median Urinary PGE-M Levels (Pre and Post Treatment) | Arm II: Zileuton and Celecoxib | Post PGE-M Levels | 3.9 | Full Range 1.2 to 10.1 | ng/mg creatinine |
| Median Urinary LTE4 Levels (Pre and Post Treatment) | Arm I: Zileuton | Pre LTE4 levels | 107 | Full Range 4 to 268 | pg/mg creatinine |
| Median Urinary LTE4 Levels (Pre and Post Treatment) | Arm II: Zileuton and Celecoxib | Pre LTE4 levels | 86 | Full Range 37 to 250 | pg/mg creatinine |
| Median Urinary LTE4 Levels (Pre and Post Treatment) | Arm I: Zileuton | Post LTE4 levels | 42 | Full Range 4 to 292 | pg/mg creatinine |
| Median Urinary LTE4 Levels (Pre and Post Treatment) | Arm II: Zileuton and Celecoxib | Post LTE4 levels | 30 | Full Range 10 to 84 | pg/mg creatinine |
| Proportion of Cases With a Post-treatment Increase in Urinary PGE-M Levels | Arm I: Zileuton | .37 | proportion of participants | ||
| Proportion of Cases With a Post-treatment Increase in Urinary PGE-M Levels | Arm II: Zileuton and Celecoxib | .06 | proportion of participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I: Zileuton | 60 | |
| Overall Study | STARTED | Arm II: Zileuton and Celecoxib | 20 | |
| Overall Study | Received Allocated Intervention | Arm I: Zileuton | 60 | |
| Overall Study | Received Allocated Intervention | Arm II: Zileuton and Celecoxib | 20 | |
| Overall Study | COMPLETED | Arm I: Zileuton | 57 | |
| Overall Study | COMPLETED | Arm II: Zileuton and Celecoxib | 20 | |
| Overall Study | NOT COMPLETED | Arm I: Zileuton | 3 | |
| Overall Study | NOT COMPLETED | Arm II: Zileuton and Celecoxib | 0 |
Source ClinicalTrials.gov
Adverse events54
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Arm I: Zileuton | 2 | 60 | |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Arm II: Zileuton and Celecoxib | 0 | 20 | |
| other | ALLERGIC RHINITIS | Respiratory, thoracic and mediastinal disorders | Arm I: Zileuton | 2 | 60 | |
| other | ALLERGIC RHINITIS | Respiratory, thoracic and mediastinal disorders | Arm II: Zileuton and Celecoxib | 1 | 20 | |
| other | CHEST WALL PAIN | Musculoskeletal and connective tissue disorders | Arm I: Zileuton | 1 | 60 | |
| other | CHEST WALL PAIN | Musculoskeletal and connective tissue disorders | Arm II: Zileuton and Celecoxib | 0 | 20 | |
| other | CONSTIPATION | Gastrointestinal disorders | Arm I: Zileuton | 3 | 60 | |
| other | CONSTIPATION | Gastrointestinal disorders | Arm II: Zileuton and Celecoxib | 0 | 20 | |
| other | DEPRESSION | Psychiatric disorders | Arm I: Zileuton | 2 | 60 | |
| other | DEPRESSION | Psychiatric disorders | Arm II: Zileuton and Celecoxib | 0 | 20 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I: Zileuton | ||
| Total, all-cause mortality | Arm II: Zileuton and Celecoxib | ||
| Total, other adverse events | Arm I: Zileuton | 26 | 60 |
| Total, other adverse events | Arm II: Zileuton and Celecoxib | 13 | 20 |
| Total, serious adverse events | Arm I: Zileuton | 0 | 60 |
| Total, serious adverse events | Arm II: Zileuton and Celecoxib | 0 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| N01CN035159 | PHASE I and II CLINICAL TRIALS OF CHEMOPREVENTIVE AGENTS-261035159-261035159 | LIPPMAN, SCOTT M. | UNIVERSITY OF TEXAS M D ANDER | DIVISION OF CANCER PREVENTION AND CONTROL | 2004 to 2006 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm I: Zileuton vs Arm II: Zileuton and Celecoxib: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01021215
GET https://conductscience.org/api/trials/v1/NCT01021215/events?page=2