Last updated: 11/03/2018 12:27:23
Carcinogenicity study of Bupropion
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Case-Control
Primary completion date:
2010-31-03
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)
No location data available.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website