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Carcinogenicity Study of Bupropion

NCT01077596 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50430

Last updated 2017-05-30

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Regular bupropion use

Regular use of bupropion is defined as use at least 4 times per week for at least 3 continuous months at least 12 months before index date.

DRUG

Regular SSRI (Selective serotonin reuptake inhibitors) use

Regular use of SSRI is defined as use at least 4 times per week for at least 3 continuous months at least 12 months before index date.

DRUG

Regular TCA (Tricyclic antidepressants) use

Regular use of TCA is defined as use at least 4 times per week for at least 3 continuous months at least 12 months before index date.

DRUG

Regular use of any other antidepressant

Regular use of any other antidepressants is defined as use at least 4 times per week for at least 3 continuous months at least 12 months before index date. An "other antidepressant" would be any antidepressant other than bupropion, a SSRI or a TCA.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-03-31
Completion
2010-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01077596 on ClinicalTrials.gov