Treximet ™ Pharmacy Budget Impact Model Database Validation Study

NCT ID: NCT01332500

Last Updated: 2017-05-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

61737 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Migraine Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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adult migraineurs with/without aura

Adult migraine patients \>18-65 years who have initiated treatment for migraine with Treximet ™ or other orally administered triptan.

Sumatriptan/Naproxen combination

Intervention Type DRUG

Sumatriptan and Naproxen Sodium

other oral triptans

Intervention Type DRUG

almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan

Interventions

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Sumatriptan/Naproxen combination

Sumatriptan and Naproxen Sodium

Intervention Type DRUG

other oral triptans

almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan

Intervention Type DRUG

Other Intervention Names

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Treximet (TM)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

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111208

Identifier Type: -

Identifier Source: org_study_id

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