Migraine DisordersNCT01381523
A Combination Product of Sumatriptan and Naproxen Sodium Versus Single-entity Oral Triptans: An Analysis of Real World Data
An observational study of Migraine Disorders, run by GlaxoSmithKline.
Trial summary
The goal of this study is to measure medical resource utilization, treatment patterns, and costs for 1.) triptan-naïve patients with new pharmacy claims for a combination treatment of sumatriptan and naproxen sodium (SumaRT/Nap) or single-entity triptan and 2.) patients who are switched from one triptan to either… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Combination therapy with sumatriptan and naproxen sodium (SumaRT/Nap) and Single-entity oral triptans
- Type of treatment
- Pill or oral medicine
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: This study will be conducted using retrospective health care claims data from insured migraine patients aged 18 to 64. Patients with a pharmacy claim for a combination treatment of sumatriptan and naproxen sodium (SumaRT/Nap) during the index period will be identified. If the SumaRT/Nap prescription is not preceeded by a single-entity triptan pharmacy claim in the 6-month, pre-index period, that patient will be included in the triptan-naive cohort. Propensity score matching will be used to identify migraine patients with new single-entity triptan claims as a comparator group. Patients with a pharmacy claim for a single-entity triptan in the 6-month, pre-index period and a pharmacy claim for SumaRT/Nap will be included in the triptan switch cohort. Propensity score matching will be used to identify patients with similar characteristics who switch to a new triptan as a comparator group.
Who may be able to join
- Patients aged 18 to 64 years
- Patients with continuous health plan eligibility during the 6-month pre-index period and follow-up period
- Patients in the triptan switch analysis must have at least one pharmacy claim for an oral triptan in the 6 month, pre-index period
Who cannot join
- Patients with a pharmacy claim for a nasal triptan at any time during the study period
- Patients with pharmacy claims for more than one type of oral triptan on the index date
- Patients in the single-entity oral triptan study groups who have a pharmacy claim for SumaRT/Nap during the 6-month follow-up period
About this study
The goal of this study is to measure medical resource utilization, treatment patterns, and costs for 1.) triptan-naïve patients with new pharmacy claims for a combination treatment of sumatriptan and naproxen sodium (SumaRT/Nap) or single-entity triptan and 2.) patients who are switched from one triptan to either SumaRT/Nap or a different single-entity triptan. The analysis will compare the mean number of prescription tablets used (including triptans, NSAIDs, opioids, and ergots) and migraine-specific medical resource utilization/costs and pharmacy costs incurred by health plan members who switched to SumaRT/Nap from a single-entity triptan. The null hypothesis for the triptan-naïve analysis is that no difference will be observed between resource utilization and costs incurred by patients treated with SumaRT/Nap and those treated with a single-entity triptan. The test hypothesis is that one group will incur significantly fewer costs and/or significantly lower health care utilization. For the triptan switch analysis, the null hypothesis is that no difference will be observed in the costs or health care utilization between triptan patients who are switched to SumaRT/Nap compared with those switched to a new triptan. The test hypothesis is that one treatment group will experience significantly lower costs and/or lower health care utilization.
The source of data for this analysis is the Lifelink Health Plan Claims Database (owned by IMS Health, Inc). This claims database includes more than 60 million covered lives. In addition to inpatient and outpatient records, this database includes standard and mail-order pharmacy claims with paid and charged amounts and dates of service.
Data from July 1, 2008 to December 31, 2009 (study period) will be used to conduct these retrospective analyses. Patients with at least one pharmacy claim for SumaRT/Nap between January 1, 2009 and June 30, 2009 (enrollment period) will be identified. The date of the first SumaRT/Nap pharmacy claim will be the index date for those patients. Each patient will be propensity score matched with an oral triptan patient based on the following pre-index covariates: age; gender; payer; geographic region; average monthly number of tablets of triptans, NSAIDs, and opioids; and average number of hospitalizations, emergency department visits, and physician visits in the month immediately preceding the index date as well as the mean number of hospitalizations, emergency department visits, and physician visits in the 5-month pre-index period. SumaRT/Nap patients and their single-entity matched controls who had no pharmacy claims for triptans prior to the index date will be analyzed in the triptan naïve group, and the SumaRT/Nap patients and their single-entity matched controls who switched to a new triptan will be analyzed in the switch analysis.
- Conditions
- Migraine Disorders
- Being tested
- Combination therapy with sumatriptan and naproxen sodium (SumaRT/Nap), Single-entity oral triptans
- Keywords
- resource utilization, naproxen sodium, cost and cost analysis, triptan, 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.
Combination therapy with sumatriptan and naproxen sodium (SumaRT/Nap)Drug
Also called Treximet® is a registered trademark of GlaxoSmithKline
Patients with new pharmacy claims for SumaRT/Nap with separate analyses for patients with at least one triptan pharmacy claim in the 6-month, pre-index period and those who are triptan-naive based on 6 months of data
Single-entity oral triptansDrug
Also called Zomig® is a registered trademark of AstraZeneca, Maxalt® is a registered trademark of Merck & Co, Inc, Relpax® is a registered trademark of Pfizer
Patients are propensity score matched to patients in the SumaRT/Nap groups and analyzed separately if patient has a pharmacy claim for a different type of triptan in the previous 6 months or is triptan treatment naive. Triptans included almotriptan, naratriptan, rizatriptan, eletriptan, zolmitriptan, frovatriptan, sumatriptan.
| Study group | Role | What they receive |
|---|---|---|
| Study-treatment naive insured adults with migraine | Adult health care plan members with a pharmacy claim for a combination product of sumatriptan and naproxen sodium (SumaRT/Nap) and propensity score matched controls with a pharmacy claim for a single-entity triptan Receives: Drug: Combination therapy with sumatriptan and naproxen sodium (SumaRT/Nap); Drug: Single-entity oral triptans | |
| Insured adults with migraine who switch study treatment | Adult health plan members with a pharmacy claim for SumaRT/Nap following at least one single-entity triptan pharmacy claim in the previous 6 months and propensity-score matched controls who switched from one single-entity triptan to another Receives: Drug: Combination therapy with sumatriptan and naproxen sodium (SumaRT/Nap); Drug: Single-entity oral triptans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of tablets dispensed
The mean number of tables dispensed as measured by pharmacy claims for prescription medications including triptans, NSAIDs, and opioids
Measured: In the 6 months immediately preceding the index date and during the 6-month follow-up period that begins at the index date
Secondary outcomes (5)
Mean and total migraine-related pharmacy costs
All costs will be adjusted to 2009 US dollars. Results will include costs to the health plan and costs to the patients. Costs will be reported for triptans, migraine prophylaxis, NSAIDs, opioids, and antiemetics
Measured: During the 6-month follow-up period that begins at the index date
Mean and total migraine-related medical costs
All costs will be adjusted to 2009 US dollars. Costs will include those for hospitizations, emergency department visits, physician visits, other outpatient visits, and other medical costs
Measured: During the 6-month follow-up period that begins at the index date
Mean numbers of migraine-related medical visits
Results will include hospitalizations, visits to the emergency department, physician visits, and other outpatient visits
Measured: During the 6-month follow-up period that begins at the index date
Mean numbers and costs (adjusted to 2009 US dollars) of all-cause resource use measures
Results will include all-cause hospitalizations, emergency department visits, physician visits, and outpatient visits. Costs reported by total, pharmacy and medical
Measured: During the 6-month follow-up period that begins at the index date
Presence of preventive medications
Pharmacy claims for migraine prophylactic medications including tricyclic antidepressants, calcium channel blockers, beta blockers, mirtazapine, venlafaxine, valproic acid, gabapentin, tiagabine, topiramate, carbamazapine, and botulinium toxin
Measured: During the 6-month follow-up period that begins at the index date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startNov 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381523
- Sponsor's protocol ID
- 113913
- Status last verified
- Feb 2013
- First submitted
- 23 Jun 2011
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combination Product of Sumatriptan and Naproxen Sodium Versus Single-entity Oral Triptans: An Analysis of Real World Data
- ClinicalTrials.gov ID
- NCT01381523
- Acronym / sponsor ID
- 113913
- Conditions
- Migraine Disorders
- Keywords
- resource utilization, naproxen sodium, cost and cost analysis, triptan, migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to measure medical resource utilization, treatment patterns, and costs for 1.) triptan-naïve patients with new pharmacy claims for a combination treatment of sumatriptan and naproxen sodium (SumaRT/Nap) or single-entity triptan and 2.) patients who are switched from one triptan to either SumaRT/Nap or a different single-entity triptan. The analysis will compare the mean number of prescription tablets used (including triptans, NSAIDs, opioids, and ergots) and migraine-specific medical resource utilization/costs and pharmacy costs incurred by health plan members who switched to SumaRT/Nap from a single-entity triptan. The null hypothesis for the triptan-naïve analysis is that no difference will be observed between resource utilization and costs incurred by patients treated with SumaRT/Nap and those treated with a single-entity triptan. The test hypothesis is that one group will incur significantly fewer costs and/or significantly lower health care utilization. For the triptan switch analysis, the null hypothesis is that no difference will be observed in the costs or health care utilization between triptan patients who are switched to SumaRT/Nap compared with those switched to a new triptan. The test hypothesis is that one treatment group will experience significantly lower costs and/or lower health care utilization.
The source of data for this analysis is the Lifelink Health Plan Claims Database (owned by IMS Health, Inc). This claims database includes more than 60 million covered lives. In addition to inpatient and outpatient records, this database includes standard and mail-order pharmacy claims with paid and charged amounts and dates of service.
Data from July 1, 2008 to December 31, 2009 (study period) will be used to conduct these retrospective analyses. Patients with at least one pharmacy claim for SumaRT/Nap between January 1, 2009 and June 30, 2009 (enrollment period) will be identified. The date of the first SumaRT/Nap pharmacy claim will be the index date for those patients. Each patient will be propensity score matched with an oral triptan patient based on the following pre-index covariates: age; gender; payer; geographic region; average monthly number of tablets of triptans, NSAIDs, and opioids; and average number of hospitalizations, emergency department visits, and physician visits in the month immediately preceding the index date as well as the mean number of hospitalizations, emergency department visits, and physician visits in the 5-month pre-index period. SumaRT/Nap patients and their single-entity matched controls who had no pharmacy claims for triptans prior to the index date will be analyzed in the triptan naïve group, and the SumaRT/Nap patients and their single-entity matched controls who switched to a new triptan will be analyzed in the switch analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study-treatment naive insured adults with migraine | – | Drug: Combination therapy with sumatriptan and naproxen sodium (SumaRT/Nap), Drug: Single-entity oral triptansAdult health care plan members with a pharmacy claim for a combination product of sumatriptan and naproxen sodium (SumaRT/Nap) and propensity score matched controls with a pharmacy claim for a single-entity triptan |
| Insured adults with migraine who switch study treatment | – | Drug: Combination therapy with sumatriptan and naproxen sodium (SumaRT/Nap), Drug: Single-entity oral triptansAdult health plan members with a pharmacy claim for SumaRT/Nap following at least one single-entity triptan pharmacy claim in the previous 6 months and propensity-score matched controls who switched from one single-entity triptan to another |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study will be conducted using retrospective health care claims data from insured migraine patients aged 18 to 64. Patients with a pharmacy claim for a combination treatment of sumatriptan and naproxen sodium (SumaRT/Nap) during the index period will be identified. If the SumaRT/Nap prescription is not preceeded by a single-entity triptan pharmacy claim in the 6-month, pre-index period, that patient will be included in the triptan-naive cohort. Propensity score matching will be used to identify migraine patients with new single-entity triptan claims as a comparator group. Patients with a pharmacy claim for a single-entity triptan in the 6-month, pre-index period and a pharmacy claim for SumaRT/Nap will be included in the triptan switch cohort. Propensity score matching will be used to identify patients with similar characteristics who switch to a new triptan as a comparator group.
Key inclusion criteria (3 listed)
- Patients aged 18 to 64 years
- Patients with continuous health plan eligibility during the 6-month pre-index period and follow-up period
- Patients in the triptan switch analysis must have at least one pharmacy claim for an oral triptan in the 6 month, pre-index period
Key exclusion criteria (3 listed)
- Patients with a pharmacy claim for a nasal triptan at any time during the study period
- Patients with pharmacy claims for more than one type of oral triptan on the index date
- Patients in the single-entity oral triptan study groups who have a pharmacy claim for SumaRT/Nap during the 6-month follow-up 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
| Intervention | Type | Arms |
|---|---|---|
| Combination therapy with sumatriptan and naproxen sodium (SumaRT/Nap)Also: Treximet® is a registered trademark of GlaxoSmithKlinePatients with new pharmacy claims for SumaRT/Nap with separate analyses for patients with at least one triptan pharmacy claim in the 6-month, pre-index period and those who are triptan-naive based on 6 months of data | Drug | Insured adults with migraine who switch study treatment, Study-treatment naive insured adults with migraine |
| Single-entity oral triptansAlso: Zomig® is a registered trademark of AstraZeneca, Maxalt® is a registered trademark of Merck & Co, Inc, Relpax® is a registered trademark of PfizerPatients are propensity score matched to patients in the SumaRT/Nap groups and analyzed separately if patient has a pharmacy claim for a different type of triptan in the previous 6 months or is triptan treatment naive. Triptans included almotriptan, naratriptan, rizatriptan, eletriptan, zolmitriptan, frovatriptan, sumatriptan. | Drug | Insured adults with migraine who switch study treatment, Study-treatment naive insured adults with migraine |
Primary outcome
Mean number of tablets dispensed
Time frame: In the 6 months immediately preceding the index date and during the 6-month follow-up period that begins at the index date
The mean number of tables dispensed as measured by pharmacy claims for prescription medications including triptans, NSAIDs, and opioids
5 secondary outcomes
Mean and total migraine-related pharmacy costs
Time frame: During the 6-month follow-up period that begins at the index date
Mean and total migraine-related medical costs
Time frame: During the 6-month follow-up period that begins at the index date
Mean numbers of migraine-related medical visits
Time frame: During the 6-month follow-up period that begins at the index date
Mean numbers and costs (adjusted to 2009 US dollars) of all-cause resource use measures
Time frame: During the 6-month follow-up period that begins at the index date
Presence of preventive medications
Time frame: During the 6-month follow-up period that begins at the index date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2013.
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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 3 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 25 Feb 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 tablets dispensed (time frame: In the 6 months immediately preceding the index date and during the 6-month follow-up period that begins at the index date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2013.