Treximet ™ Pharmacy Budget Impact Model Database Validation Study

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01332500
First received: March 21, 2011
Last updated: April 19, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Migraine Disorders
Drug: Sumatriptan/Naproxen combination
Drug: other oral triptans

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Treximet ™ Pharmacy Budget Impact Model Database Validation Study

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The mean number of tablets per participant was computed using prescription fills dispensed in the 6-month follow-up period. "Other" represents acetaminophen (APAP)/isometheptene/dichlorphenazone and APAP/isometheptene/caffeine, for example. The number of tablets dispensed was obtained from the "quantity dispensed field" in the claims data. Triptan tablets were classified as index and non-index medication (if a different oral triptan was filled from that of the index medication); only oral triptans were considered (i.e., excluded injectable triptans).

  • Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis [ Time Frame: 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) ] [ Designated as safety issue: No ]
    Health plan cost was defined as the pharmacy costs. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy costs were calculated as the mean of the total costs of the five drug categories.

  • Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis [ Time Frame: 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) ] [ Designated as safety issue: No ]
    Mean Total Cost was defined as the pharmacy cost plus the participant copay. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy cost plus participant copay was calculated as the mean of the total costs (pharmacy cost plus participant copay) of the five drug categories.

  • Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch Analysis [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The mean number of tablets per participant was computed using prescription fills dispensed in the 6-month follow-up period. "Other" represents APAP/isometheptene/dichlorphenazone and APAP/isometheptene/caffeine, for example. The number of tablets dispensed was obtained from the "quantity dispensed field" in the claims data. Triptan tablets were classified as index and non-index medication (if a different oral triptan was filled from that of the index medication); only oral triptans were considered (i.e., excluded injectable triptans).

  • Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis [ Time Frame: 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) ] [ Designated as safety issue: No ]
    Health Pan Cost was defined as the pharmacy costs. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy costs were calculated as the mean of the total costs of the five drug categories.

  • Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis [ Time Frame: 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) ] [ Designated as safety issue: No ]
    Mean Total Cost was defined as the pharmacy cost plus the participant copay. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). .Pharmacy cost plus participant copay was calculated as the mean of the total costs (pharmacy cost plus participant copay) of the five drug categories.


Enrollment: 61737
Study Start Date: July 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
adult migraineurs with/without aura
Adult migraine patients >18-65 years who have initiated treatment for migraine with Treximet ™ or other orally administered triptan.
Drug: Sumatriptan/Naproxen combination
Sumatriptan and Naproxen Sodium
Other Name: Treximet (TM)
Drug: other oral triptans
almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subject data from a claims database having at least one pharmacy claim for Treximet ™ or an orally administered triptan during the study period.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332500

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01332500     History of Changes
Other Study ID Numbers: 111208
Study First Received: March 21, 2011
Results First Received: March 21, 2011
Last Updated: April 19, 2011
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
Triptans
Migraine

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Naproxen
Sumatriptan
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Vasoconstrictor Agents
Cardiovascular Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 21, 2014