Carcinogenicity Study of Bupropion

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01077596
First received: February 25, 2010
Last updated: June 2, 2011
Last verified: June 2011
Results First Received: 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  
Number of Participants  
[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  
Gender  
[units: Participants]
                         
Female     126     378     175     525     91     273     308     837     2842     28420     0     0     33975  
Male     224     672     282     845     203     609     0     0     0     0     2215     22150     27200  
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


No publications provided


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01077596     History of Changes
Other Study ID Numbers: 111982, EPI40463, WEUKSTV1113
Study First Received: February 25, 2010
Results First Received: January 21, 2011
Last Updated: June 2, 2011
Health Authority: United Kingdom: No Health Authority