Last updated: 11/07/2018 05:20:32
EPIP083: Buproprion Pregnancy Registry
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: EPIP083: Buproprion Pregnancy Registry
Trial description: EPIP083: Buproprion Pregnancy Registry
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Cole JA, Modell JG, Haight BR, Cosmatos IS, Stoler JM, Walker AM. Bupropion in pregnancy and the prevalence of congenital malformations. Pharmacoepidemiology and Drug Safety 2007; 16: 474-484. http://www.gsk-clinicalstudyregister.com/files/pdf/24100.pdf
Correa A, Cragan JD, Kucik JE, Alverson CJ, Gilboa SM, Balakrishnan R, et al. Reporting birth defects surveillance data 1968-2003. Birth Defects Res A Clin Mol Teratol. 2007;79(2):65-186. Errata published in: Birth Defects Res A Clin Mol Teratol. 2008;82(1):41-62. To access an electronic copy of the report, go to http://www.cdc.gov/ncbddd/bd/macdp_resources.htm. To access an electronic copy of the errata, go to http://www3.interscience.wiley.com/journal/117887251/issue.
Fleiss JL. Statistical Methods for Rates and Proportions. New York: John Wiley; 1981;14-15.
Food and Drug Administration. Guidance for Industry: Establishing pregnancy exposure registries. Rockville (MD): US Department of Health and Human Services, Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research; 2002. Available from URL: http://www.fda.gov/cber/gdlns/pregnancy.pdf.
Medical condition
Depressive Disorder
Product
bupropion
Collaborators
Not applicable
Study date(s)
September 1997 to August 2008
Type
Not applicable
Phase
Not applicable
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
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
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2008-01-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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