Last updated: 11/03/2018 11:29:12

Treximet ™ Pharmacy Budget Impact Model database validation study

GSK study ID
111208
See study documents
Clinicaltrials.gov ID
NCT01332500
See results summary
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: Treximet ™ Pharmacy Budget Impact Model database validation study
Trial description: The purpose of this retrospective claims database study was to compare the change in migraine-related prescription (i.e. NSAIDs, Opioids, Ergots) utilization among migraine suffers following initiation of Treximet ™ (sumatriptan/naproxen) compared with subjects initiating treatment with other orally available triptans. The study was used to validate the migraine-related prescription utilization patterns predicted by the Treximet ™ Budget Impact Model.
The SourceLx dataset from the family of Wolters Kluwer databases was used for this analysis. The database contains 30% of prescription claims filled in the United States (US), approximately 160 million patient lives. The data has broad representative coverage at both the geographic and payment levels.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Mean Number of Triptan Tablets per Participant in 6-month Follow-up Period: Treatment-naïve Analysis

Timeframe: 6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)

Mean Health Plan Cost per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis

Timeframe: 6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)

Mean Total Cost (health plan plus participant copay costs) per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis

Timeframe: 6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)

Mean Number of Triptan Tablets per Participant in 6-month Follow-up Period: Treatment-switch Analysis

Timeframe: 6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)

Mean Health Plan Cost per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis

Timeframe: 6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)

Mean Total Cost (health plan plus participant copay costs) per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis

Timeframe: 6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Sumatriptan/Naproxen combination
  • Drug: other oral triptans
    • Enrollment:
    61737
    Primary completion date:
    2010-22-03
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Migraine Disorders
    Product
    naproxen, sumatriptan, sumatriptan/naproxen
    Collaborators
    Not applicable
    Study date(s)
    July 2009 to March 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    No
    • At least one prescription claim for either Treximet ™ or orally administered triptan
    • at least 18 years of age at index Rx date
    • Subjects receiving nasal sumatriptan at any time
    • Subjects over 65 years of age
    Inclusion and exclusion criteria
    Inclusion criteria:
    • At least one prescription claim for either Treximet ™ or orally administered triptan
    • at least 18 years of age at index Rx date
    • at least one prescription claim for any medication in the pre- and post-index period (proxy for continuous enrollment)
    Exclusion criteria:
    • Subjects receiving nasal sumatriptan at any time
    • Subjects over 65 years of age

    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
    2010-22-03
    Actual study completion date
    2010-22-03

    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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