Last updated: 11/03/2018 19:33:56

AOA: Lamictal Generic Switching Feasibility Analysis

GSK study ID
116781
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: AOA: Lamictal Generic Switching Feasibility Analysis
Trial description: Rationale: With the expiration of the patent for branded lamotrigine, a generic form a lamotrigine was approved by the FDA on July 22, 2008. Consequently, due to payer drug plan designs and impact on copayments, many persons have switched to a generic form of the drug. There has been discussion within the payer organization regarding the potential cost and ER impact related to subjects switching from branded to generic lamotrigine.
Objectives: To determine the need for and feasibility of conducting further research to better understand medication switching between brand and generic lamotrigine.
Data Source: The Ingenix Impact National Benchmark Database™ is a comprehensive, de-identified U.S. healthcare claims database that is representative of the non-elderly, insurance-carrying population in the U.S. The database contains inpatient/outpatient and pharmacy claims, lab results and enrolment information on over 98.4 million lives from 1997 to 2009.
Study Design: Retrospective observational cohort
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Difference in healthcare costs

Timeframe: Time from index date (initial lamotrigine fill) to index date plus 6 months

Secondary outcomes:

Difference in epilepsy ER visits

Timeframe: Time from index date (initial lamotrigine fill) to index date plus 6 months

Difference in ER visits

Timeframe: Time from index date (initial lamotrigine fill) to index date plus 6 months

Difference in epilepsy healthcare costs

Timeframe: Time from index date (initial lamotrigine fill) to index date plus 6 months

Interventions:
  • Drug: Lamotrigine (generic)
  • Drug: Lamotrigine (brand)
    • Enrollment:
    1852
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Epilepsy
    Product
    lamotrigine
    Collaborators
    Not applicable
    Study date(s)
    September 2010 to October 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    none
    • At least one Rx for lamotrigine
    • Epilepsy diagnosis
    • Bipolar diagnosis
    • Lamotrigine Rx in 6 months pre-index
    Inclusion and exclusion criteria
    Inclusion criteria:
    • At least one Rx for lamotrigine
    • Epilepsy diagnosis
    • Continuous coverage for 6 months pre-index and 6 months post-index
    Exclusion criteria:
    • Bipolar diagnosis
    • Lamotrigine Rx in 6 months pre-index

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2010-07-10

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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