Migraine DisordersNCT01332500

Treximet ™ Pharmacy Budget Impact Model Database Validation Study

An observational study of Migraine Disorders, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Migraine Disorders
What is being tested?: Sumatriptan/Naproxen combination and other oral triptans
Type of treatment: Pill or oral medicine
How many people: 61,737 participants
Where: No sites listed yet
Study dates: Jul 2009to Mar 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
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.

Who may be able to join

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)

Who cannot join

Subjects receiving nasal sumatriptan at any time
Subjects over 65 years of age

About this study

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.

Conditions: Migraine Disorders
Being tested: Sumatriptan/Naproxen combination, other oral triptans
Keywords: Triptans, Migraine
Medical subject headings: Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sumatriptan/Naproxen combinationDrug
Also called Treximet (TM)
Sumatriptan and Naproxen Sodium
other oral triptansDrug
almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan

Study groups in NCT01332500
Study group	Role	What they receive
adult migraineurs with/without aura		Adult migraine patients >18-65 years who have initiated treatment for migraine with Treximet ™ or other orally administered triptan. Receives: Drug: Sumatriptan/Naproxen combination; Drug: other oral triptans

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009Mar 2010

First posted11 Apr 2011 (estimated)
Study startJul 2009
Primary completionMar 2010
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Migraine DisordersStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 61,737 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01332500
Sponsor's protocol ID: 111208
Status last verified: May 2017
First submitted: 21 Mar 2011
Last updated: 30 May 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Migraine Disorders trials

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

Arm	Type	Receives
adult migraineurs with/without aura	–	Drug: Sumatriptan/Naproxen combination, Drug: other oral triptansAdult migraine patients >18-65 years who have initiated treatment for migraine with Treximet ™ or other orally administered triptan.

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.

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (2 listed)

Subjects receiving nasal sumatriptan at any time
Subjects over 65 years of age

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

Interventions

Intervention	Type	Arms
Sumatriptan/Naproxen combinationAlso: Treximet (TM)Sumatriptan and Naproxen Sodium	Drug	adult migraineurs with/without aura
other oral triptansalmotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan	Drug	adult migraineurs with/without aura

Primary outcome

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).
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.
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.
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).
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.
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

Results posted to the registry on 11 Apr 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Naïve - Sumatriptan/Naproxen Sodium	13,257	13,257
Naïve - Oral Triptan	39,771	39,771
Switch - Sumatriptan/Naproxen Sodium	2,903	2,903
Switch - Oral Triptan	5,806	5,806

Primary outcome: 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). Mean (Standard Deviation). Unit: tablets per participant

Measure	Naïve - Sumatriptan/Naproxen Sodium n = 13257	Naïve - Oral Triptan n = 39771
Triptans	17.7 (16.3)	18.4 (18.2)
Non-steroidal anti-inflammatory drugs	19.2 (57.1)	21.5 (64.9)
Opioids	75.8 (219.0)	80.1 (235.8)
Ergots	0.1 (3.6)	0.1 (2.4)
Other	1.5 (17.0)	1.4 (13.9)

Naïve - Sumatriptan/Naproxen Sodium vs Naïve - Oral Triptan: p <0.001, paired t-test 2-sided
Naïve - Sumatriptan/Naproxen Sodium vs Naïve - Oral Triptan: p <0.001, paired t-test 2-sided
Naïve - Sumatriptan/Naproxen Sodium vs Naïve - Oral Triptan: p = 0.005, paired t-test 2-sided

Population analysed: The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.

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

Measure	Naïve - Sumatriptan/Naproxen Sodium n = 13257	Naïve - Oral Triptan n = 39771
Triptans	284 (366.1)	333 (393.7)
Non-steroidal anti-inflammatory drugs	9 (62.3)	9 (62.5)
Opioids	38 (609.7)	43 (477.6)
Ergots	2 (33.1)	2 (51.2)
Other	0 (5.1)	0 (4.8)
Total	332 (732.1)	387 (645.4)

Naïve - Sumatriptan/Naproxen Sodium vs Naïve - Oral Triptan: p <0.001, paired t-test 2-sided
Naïve - Sumatriptan/Naproxen Sodium vs Naïve - Oral Triptan: p = 0.349, paired t-test 2-sided
Naïve - Sumatriptan/Naproxen Sodium vs Naïve - Oral Triptan: p = 0.208, paired t-test 2-sided

Primary outcome: Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis

Measure	Naïve - Sumatriptan/Naproxen Sodium n = 13257	Naïve - Oral Triptan n = 39771
Triptans	349 (396.4)	397 (418.9)
Non-steroidal anti-inflammatory drugs	11 (69.8)	12 (72.5)
Opioids	49 (621.0)	54 (509.5)
Ergots	2 (36.6)	2 (55.5)
Other	1 (8.6)	1 (7.2)
Total	412 (757.7)	466 (687.7)

Naïve - Sumatriptan/Naproxen Sodium vs Naïve - Oral Triptan: p <0.001, paired t-test 2-sided
Naïve - Sumatriptan/Naproxen Sodium vs Naïve - Oral Triptan: p = 0.177, paired t-test 2-sided
Naïve - Sumatriptan/Naproxen Sodium vs Naïve - Oral Triptan: p = 0.173, paired t-test 2-sided

Primary outcome: 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). Mean (Standard Deviation). Unit: tablets per participant

Measure	Switch - Sumatriptan/Naproxen Sodium n = 2903	Switch - Oral Triptan n = 5806
Triptans	24.4 (20.7)	24.4 (20.2)
Non-steroidal anti-inflammatory drugs	20.9 (62.5)	22.9 (70.9)
Opioids	88.4 (254.7)	87.4 (255.7)
Ergots	0.0 (1.6)	0.1 (3.7)
Other	1.4 (14.9)	1.3 (12.1)

Switch - Sumatriptan/Naproxen Sodium vs Switch - Oral Triptan: p = 0.866, paired t-test 2-sided
Switch - Sumatriptan/Naproxen Sodium vs Switch - Oral Triptan: p = 0.094, paired t-test 2-sided
Switch - Sumatriptan/Naproxen Sodium vs Switch - Oral Triptan: p = 0.832, paired t-test 2-sided

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Naïve - Sumatriptan/Naproxen Sodium	0 of 0	0 of 0	Not reported
Naïve - Oral Triptan	0 of 0	0 of 0	Not reported
Switch - Sumatriptan/Naproxen Sodium	0 of 0	0 of 0	Not reported
Switch - Oral Triptan	0 of 0	0 of 0	Not reported

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.

GSK Clinical Trials study director

GlaxoSmithKline

Questions about this trial

What is this clinical trial studying?

An observational study of Migraine Disorders, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01332500.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.