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WEUSKOP6166: Lamotrigine and Aseptic Meningitis

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Contents

clinicaltrials.gov/study/NCT01657864
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT016578640
Health Conditions in Trial
Epilepsy
Epilepsy
0
Trial Recruitment Size
10
Trial Sponsor
GlaxoSmithKline
GlaxoSmithKline
0
Clinical Trial Start Date
2012
0
Primary Completion Date
2012
0
Study Completion Date
2012
0
Clinical Trial Study Type
Observational0
Intervention Type
Drug0
Observational Study Perspective
Cross-Sectional0
Official Name
WEUSKOP6166: Prevalence of Aseptic Meningitis Among Lamotrigine Users0
Last Updated
August 6, 2012
0

Other attributes

Intervention Treatment
Lamotrigine0
Study summary

The objective of the study is to quantify the number of cases of aseptic meningitis among users of Lamotrigine. This study is a cross-sectional study design using data on lamotrigine patients within the Thomson Reuters MarketScan® Commercial database (MarketScan database). The MarketScan database is a US-based insurance claims database representative of a US insured population and includes supplemental datao n Medicare patients. This cross-sectional study will evaluate the number of cases of aseptic meningitis among lamotrigine users during the duration of lamotrigine therapy, with an extended exposure window of 30 days after completing therapy. The MarketScan® Database is an US insurance claims database that is held in-house at GSK, which can be interrogated to examine rates of prescribing and medical conditions that can be captured via ICD-9 diagnoses codes. The MarketScan database captures person-specific clinical utilization, expenditures, and enrollment across inpatient, outpatient, prescription drug, and carve-out services from a selection of large employers, health plans, and government and public organizations. The annual medical databases include private sector health data from approximately 100 payers. In 2011, there were approximately 35 million patients on the database. The Commercial Claims and Encounters Database represents the medical experience of insured employees and their dependents for active employees, early retirees, COBRA continues, and their dependents insured by employer-sponsored plans (i.e., non-Medicare eligibles). In addition, a linked Medstat Medicare database contains predominantly fee-for-service plan data in insurance plans where both the Medicare-paid amounts and the employer-paid amounts were available and evident on the claims.The data are HIPAA compliant thus all patients have been anonymized.

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