Trial record 1 of 1 for:    Zileuton With or Without Celecoxib As Chemopreventive Agents in Smokers
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Zileuton With or Without Celecoxib As Chemopreventive Agents in Smokers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01021215
First received: November 24, 2009
Last updated: April 1, 2015
Last verified: October 2013
Results First Received: December 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Tobacco Use Disorder
Interventions: Drug: Zileuton
Drug: Celecoxib
Other: laboratory biomarker analysis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: May 5, 2010 to September 12, 2011. All recruitment done in medical clinics at Weill Cornell Medical College (WCMC), a Participating Organization within the MD Anderson Cancer Center (MDACC) Consortium.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 84 subjects were enrolled, four withdrew for different reasons before beginning study medication leaving 80 subjects started on the study medication(s).

Reporting Groups
  Description
Arm I: Zileuton Zileuton 1200 mg twice orally twice a day on days 1-6.
Arm II: Zileuton and Celecoxib Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.

Participant Flow:   Overall Study
    Arm I: Zileuton     Arm II: Zileuton and Celecoxib  
STARTED     60     20  
Received Allocated Intervention     60     20  
COMPLETED     57     20  
NOT COMPLETED     3     0  
Lost to Follow-up                 3                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Of the 80 participants treated three (3) were lost to follow up leaving 77 who completed treatment, and of those reflected as a subset are the 70 compliant participants who completed treatment.

Reporting Groups
  Description
Arm I: Zileuton Zileuton 1200 mg twice orally twice a day on days 1-6.
Arm II: Zileuton and Celecoxib Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
Total Total of all reporting groups

Baseline Measures
    Arm I: Zileuton     Arm II: Zileuton and Celecoxib     Total  
Number of Participants  
[units: participants]
  60     20     80  
Age  
[units: years]
Median ( Full Range )
  45  
  ( 25 to 64 )  
  43  
  ( 30 to 54 )  
  43  
  ( 25 to 64 )  
Gender  
[units: participants]
     
Female     24     8     32  
Male     36     12     48  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     2     2  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     28     7     35  
White     31     10     41  
More than one race     0     0     0  
Unknown or Not Reported     1     1     2  
Region of Enrollment  
[units: participants]
     
United States     60     20     80  
Smoking (Packs per Year) [1]
[units: cigarette packs]
Median ( Full Range )
  19.5  
  ( 10 to 68 )  
  19.5  
  ( 10 to 40 )  
  19.5  
  ( 10 to 68 )  
Baseline PGE-M (ng/mg Cr) [2]
[units: ng/mg Cr]
Median ( Full Range )
  12.8  
  ( 1.4 to 50.4 )  
  10.2  
  ( 2.3 to 35.1 )  
  12.6  
  ( 1.4 to 50.4 )  
Baseline LTE4 (pg/mg CR) [3]
[units: pg/mg CR]
Median ( Full Range )
  107  
  ( 4 to 268 )  
  86.5  
  ( 37 to 250 )  
  102.5  
  ( 4 to 268 )  
Gender, Male/Female: Compliant Participants [4]
[units: participants]
     
Female     19     8     27  
Male     33     10     43  
Race, Compliant Participants [5]
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     2     2  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     28     7     35  
White     24     9     33  
Unknown or Not Reported     0     0     0  
Age, Continuous, Compliant Participants [5]
[units: years]
Mean ± Standard Deviation
  43.8  ± 9.6     43.1  ± 7.6     43.6  ± 9.1  
[1] Number of cigarette packs smoked annually; Measure includes the 70 compliant participants only.
[2] Prostaglandin E metabolite (PGE-M) levels via creatinine (Cr) in the urine measured by a chemical assay. Baseline measure includes the 70 compliant study participants only.
[3] Leukotriene E4 (LTE4) levels via creatinine (Cr) in the urine measured by a chemical assay. Baseline measure includes the 70 compliant study participants only.
[4] Measure includes the 70 compliant study participants only.
[5] Baseline measure includes the 70 compliant study participants only.



  Outcome Measures
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1.  Primary:   Median Urinary PGE-M Levels (Pre and Post Treatment)   [ Time Frame: Baseline and Day 6 ]

2.  Primary:   Median Urinary LTE4 Levels (Pre and Post Treatment)   [ Time Frame: Baseline and day 6 ]

3.  Secondary:   Proportion of Cases With a Post-treatment Increase in Urinary PGE-M Levels   [ Time Frame: Baseline to Day 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Powel H. Brown, MD Anderson Phase I/II Prevention Consortium
Organization: University of Texas (UT) MD Anderson Cancer
phone: (713) 745-3672
e-mail: CR_Study_Registration@mdanderson.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01021215     History of Changes
Other Study ID Numbers: NCI-2013-00730, NCI-2013-00730, 2009-0804, 2009-0804, N01CN35159
Study First Received: November 24, 2009
Results First Received: December 17, 2014
Last Updated: April 1, 2015
Health Authority: United States: Food and Drug Administration
United States: Federal Government