Last updated: 11/03/2018 12:27:23

Carcinogenicity study of Bupropion

GSK study ID
111982
See study documents
Clinicaltrials.gov ID
NCT01077596
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Post-marketing carcinogenicity study of Bupropion
Trial description: There is a lack of toxicology data on one bupropion metabolite, and limited literature examining bupropion use and cancer risk. This study evaluates the association between bupropion exposure and the development of cancer of the prostate, breast, lung, colon/rectum, urinary bladder, and uterus by comparing the risk of cancer in bupropion users with other antidepressant users. Because there is no evidence that bupropion is associated with any particular cancer, we have chosen the six most common cancers diagnosed in the United States to optimize statistical power/precision for cancer-site specific comparisons. Two US population-based data resources with automated claims, pharmacy, and tumor registry data are included in this study. Using a nested case-control design, this study will compare the incidence of cancer in patients exposed to bupropion with the incidence in patients exposed to other antidepressants.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants diagnosed with any of the cancers under investigation who were regularly exposed to the indicated antidepressant

Timeframe: January 1, 1996 – December 31, 2006

Secondary outcomes:

Number of participants diagnosed with Colorectal Cancer who were regularly exposed to the indicated antidepressant

Timeframe: January 1, 1996 – December 31, 2006

Number of participants diagnosed with lung cancer who were regularly exposed to the indicated antidepressant

Timeframe: January 1, 1996 – December 31, 2006

Number of participants diagnosed with bladder cancer who were regularly exposed to the indicated antidepressant

Timeframe: January 1, 1996 – December 31, 2006

Number of participants diagnosed with uterine cancer who were regularly exposed to the indicated antidepressant

Timeframe: January 1, 1996 – December 31, 2006

Number of participants diagnosed with breast cancer who were regularly exposed to the indicated antidepressant

Timeframe: January 1, 1996 – December 31, 2006

Number of participants diagnosed with prostate cancer who were regularly exposed to the indicated antidepressant

Timeframe: January 1, 1996 – December 31, 2006

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
    • Enrollment:
    50430
    Primary completion date:
    2010-31-03
    Observational study model:
    Case-Control
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Depressive Disorder, Cancer
    Product
    bupropion
    Collaborators
    Not applicable
    Study date(s)
    June 2008 to March 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Cancers diagnosed within 12 months of initiation (i.e., new use) of antidepressant pharmacotherapy will be excluded to account for a minimum period for the development of cancer (cancer latency) and to be consistent with other studies of antidepressants and cancer.
    • Patients with a history of any cancer (cancer diagnosis recorded in the tumor registries anytime before the first antidepressant prescription recorded during the study period)
    Inclusion and exclusion criteria
    Exclusion criteria:
    • Cancers diagnosed within 12 months of initiation (i.e., new use) of antidepressant pharmacotherapy will be excluded to account for a minimum period for the development of cancer (cancer latency) and to be consistent with other studies of antidepressants and cancer. -Patients with a history of any cancer (cancer diagnosis recorded in the tumor registries anytime before the first antidepressant prescription recorded during the study period) -Any antidepressant use within 6 months of January 1, 1996

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2010-31-03
    Actual study completion date
    2010-31-03

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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