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
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
Not applicable
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)

No location data available.

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
Finalized
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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