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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01657864
Other study ID # 117051
Secondary ID WEUSKOP6166
Status Completed
Phase N/A
First received August 2, 2012
Last updated August 2, 2012
Start date May 2012
Est. completion date July 2012

Study information

Verified date July 2012
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United States: No Health Authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients must be using lamotrigine for epilepsy or bipolar disorder.

- Patients must have at least 180 days history on the database prior to the index of lamotrigine use.

- Patients must have medical and pharmacy coverage throughout the study, with no gaps in eligibility.

Exclusion Criteria:

Study Design

Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Drug:
Lamotrigine
Lamotrigine is an anticonvulsant drug used in the treatment of epilepsy and bipolar disorder

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Outcome

Type Measure Description Time frame Safety issue
Primary Aseptic meningitis during the period of time the patient is taking lamotrigine The exposure window will be extended by 30 days to be consistent with current pharmacovigilance polices at GSK. Aseptic meningitis coded within this window shall be included in the rate The period at-risk for aseptic meningitis shall begin with the date of the new prescription for lamotrigine and will end 30 days after the last dose of the drug Yes
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