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Carcinogenicity Study of Bupropion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01077596
First Posted: March 1, 2010
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: January 21, 2011  
Study Type: Observational
Study Design: Observational Model: Case-Control;   Time Perspective: Retrospective
Conditions: Depressive Disorder
Cancer
Interventions: Drug: Regular bupropion use
Drug: Regular SSRI (Selective serotonin reuptake inhibitors) use
Drug: Regular TCA (Tricyclic antidepressants) use
Drug: Regular use of any other antidepressant

  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
Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
New Antidepressant Exposure in Colorectal Cancer: Cases New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Cases
New Antidepressant Exposure in Colorectal Cancer: Controls New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Controls
New Antidepressant Exposure in Lung Cancer: Cases New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Cases
New Antidepressant Exposure in Lung Cancer: Controls New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Controls
New Antidepressant Exposure in Bladder Cancer: Cases New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Cases
New Antidepressant Exposure in Bladder Cancer: Controls New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Controls
Antidepressant Exposure in Uterine Cancer: Cases New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Cases
New Antidepressant Exposure in Uterine Cancer: Controls New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Controls
New Antidepressant Exposure in Breast Cancer: Cases New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Cases
New Antidepressant Exposure in Breast Cancer: Controls New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Controls
New Antidepressant Exposure in Prostate Cancer: Cases New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Cases
New Antidepressant Exposure in Prostate Cancer: Controls New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Controls

Participant Flow:   Overall Study
    New Antidepressant Exposure in Colorectal Cancer: Cases   New Antidepressant Exposure in Colorectal Cancer: Controls   New Antidepressant Exposure in Lung Cancer: Cases   New Antidepressant Exposure in Lung Cancer: Controls   New Antidepressant Exposure in Bladder Cancer: Cases   New Antidepressant Exposure in Bladder Cancer: Controls   Antidepressant Exposure in Uterine Cancer: Cases   New Antidepressant Exposure in Uterine Cancer: Controls   New Antidepressant Exposure in Breast Cancer: Cases   New Antidepressant Exposure in Breast Cancer: Controls   New Antidepressant Exposure in Prostate Cancer: Cases   New Antidepressant Exposure in Prostate Cancer: Controls
STARTED   350   1050   457   1370   294   882   308   837   2842   28420   2215   22150 
COMPLETED   350   1050   457   1370   294   882   308   837   2842   28420   2215   22150 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0   0   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.
No text entered.

Reporting Groups
  Description
New Antidepressant Exposure in Colorectal Cancer: Cases New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Cases
New Antidepressant Exposure in Colorectal Cancer: Controls New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Controls
New Antidepressant Exposure in Lung Cancer: Cases New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Cases
New Antidepressant Exposure in Lung Cancer: Controls New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Controls
New Antidepressant Exposure in Bladder Cancer: Cases New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Cases
New Antidepressant Exposure in Bladder Cancer: Controls New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Controls
New Antidepressant Exposure in Uterine Cancer: Cases New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Cases
New Antidepressant Exposure in Uterine Cancer: Controls New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Controls
New Antidepressant Exposure in Breast Cancer: Cases New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Cases
New Antidepressant Exposure in Breast Cancer: Controls New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Controls
New Antidepressant Exposure in Prostate Cancer: Cases New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Cases
New Antidepressant Exposure in Prostate Cancer: Controls New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Controls
Total Total of all reporting groups

Baseline Measures
   New Antidepressant Exposure in Colorectal Cancer: Cases   New Antidepressant Exposure in Colorectal Cancer: Controls   New Antidepressant Exposure in Lung Cancer: Cases   New Antidepressant Exposure in Lung Cancer: Controls   New Antidepressant Exposure in Bladder Cancer: Cases   New Antidepressant Exposure in Bladder Cancer: Controls   New Antidepressant Exposure in Uterine Cancer: Cases   New Antidepressant Exposure in Uterine Cancer: Controls   New Antidepressant Exposure in Breast Cancer: Cases   New Antidepressant Exposure in Breast Cancer: Controls   New Antidepressant Exposure in Prostate Cancer: Cases   New Antidepressant Exposure in Prostate Cancer: Controls   Total 
Overall Participants Analyzed 
[Units: Participants]
 350   1050   457   1370   294   882   308   837   2842   28420   2215   22150   61175 
Age, Customized 
[Units: Participants]
                         
45-54 years   34   102   47   140   17   51   59   172   678   6780   193   1930   10203 
55-64 years   73   219   102   306   63   189   90   245   849   8490   669   6690   17985 
65-74 years   119   357   159   477   104   312   84   224   707   7070   877   8770   19260 
>=75 years   124   372   149   447   110   330   75   196   608   6080   476   4760   13727 
Sex: Female, Male 
[Units: Participants]
Count of Participants
                         
Female      126  36.0%      378  36.0%      175  38.3%      525  38.3%      91  31.0%      273  31.0%      308 100.0%      837 100.0%      2842 100.0%      28420 100.0%      0   0.0%      0   0.0%      33975  55.5% 
Male      224  64.0%      672  64.0%      282  61.7%      845  61.7%      203  69.0%      609  69.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      2215 100.0%      22150 100.0%      27200  44.5% 
Number of participants diagnosed with the indicated conditions and using the indicated therapies [1] 
[Units: Participants]
                         
Exposed to multiple antidepressants   47   160   62   191   44   147   53   162   564   5756   340   3782   11308 
Ever smokers   252   643   428   772   247   573   142   389   0   0   0   0   3446 
Unknown smoking status   4   70   5   183   1   29   4   27   0   0   0   0   323 
Ever diagnosed (dx) with depression   110   329   108   408   83   273   119   319   1091   10541   677   6700   20758 
Ever dx with inflammatory bowel disease (IBD)   1   9   0   0   0   0   0   0   0   0   0   0   10 
Users of oral contraceptives (OC)   6   7   0   0   0   0   8   45   236   1987   0   0   2289 
Users of hormone replacement therapy (HRT)   57   225   0   0   0   0   153   441   1796   17184   0   0   19856 
Users of NSAIDs   269   859   370   1123   0   0   0   0   2340   23730   1800   17887   48378 
[1] A value of “0” indicates that no data are available for that particular treatment arm. Smoking status data were not collected for breast cancer and prostate cancer cases and controls, as it is not a necessary variable for analysis. NSAIDS, non-steroidal anti-inflammatory drugs.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant   [ Time Frame: January 1, 1996 – December 31, 2006 ]

2.  Secondary:   Number of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated Antidepressant   [ Time Frame: January 1, 1996 – December 31, 2006 ]

3.  Secondary:   Number of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated Antidepressant   [ Time Frame: January 1, 1996 – December 31, 2006 ]

4.  Secondary:   Number of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated Antidepressant   [ Time Frame: January 1, 1996 – December 31, 2006 ]

5.  Secondary:   Number of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated Antidepressant   [ Time Frame: January 1, 1996 – December 31, 2006 ]

6.  Secondary:   Number of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated Antidepressant   [ Time Frame: January 1, 1996 – December 31, 2006 ]

7.  Secondary:   Number of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated Antidepressant   [ Time Frame: January 1, 1996 – December 31, 2006 ]


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01077596     History of Changes
Other Study ID Numbers: 111982
EPI40463
WEUKSTV1113
First Submitted: February 25, 2010
First Posted: March 1, 2010
Results First Submitted: January 21, 2011
Results First Posted: February 10, 2011
Last Update Posted: May 30, 2017