Treximet ™ Pharmacy Budget Impact Model Database Validation Study

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Treximet ™ Pharmacy Budget Impact Model Database Validation Study

ClinicalTrials.gov ID

NCT01332500

Acronym / sponsor ID

111208

Conditions

Migraine Disorders

Keywords

Triptans, Migraine

Study type

Observational

Recruitment status

Completed

Enrolment

61,737 participants (actual)

Lead sponsor

GlaxoSmithKlineIndustry (pharma, biotech, devices)

Study start

Jul 2009

Primary completion

Mar 2010 (actual)

Study completion

Mar 2010 (actual)

First posted

11 Apr 2011 (estimated)

Results

Posted 11 Apr 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Retrospective

Number of arms

1

Who may qualify

Ages

18 to 65 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. 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)

   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).

2. 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)

   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.

3. 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)

   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.

4. 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)

   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).

5. 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)

   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.

6. 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)

   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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.