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Impact of Migraine on Work Productivity in Patients Treated With a Combination Product Containing Sumatriptan and Naproxen Sodium or Triptan Monotherapy

NCT01381497 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2012-08-27

No results posted yet for this study

Summary

Migraine headaches lead to absenteeism and can restrict on-the-job productivity (presenteeism) for employed migraine sufferers. Effective migraine treatments should reduce migraine-associated productivity losses and return migraineurs to normal functioning within a few hours of treatment.

This study is an observational, multicenter, parallel-group study of employed patients who have been prescribed either a combination product containing sumatriptan and naproxen sodium (SumaRT/Nap) or oral triptan monotherapy to treat acute migraine attacks. The study will report results from 4 migraine attacks per patient. Eligible migraine attacks will be defined as those preceded by a 24-hour, headache-free period with onset between 2 hours prior to the start of and 4 hours before the end of a scheduled work shift. Data will be collected at time of treatment and hourly until the end of the attack or the end of the workday. To estimate baseline productivity, data will be collected from 50 randomly selected subjects during a migraine-free workday.

The primary objective of this study is to compare migraine-related, work productivity losses (absenteeism and presenteeism) reported by patients treated with SumaRT/Nap to losses reported by patients treated with triptan monotherapy. The null hypothesis is that no difference will be observed between the number of hours of productivity lost for patients who treat workday migraine attacks with SumaRT/Nap and patients who treat migraine attacks with an oral triptan alone. The alternative hypotheses are that patients in either treatment group experience significantly fewer hours of lost productivity associated with migraine compared to patients in the other treatment group.

The secondary objectives of this study are to measure the time between treatment and return to patient-reported, normal functioning; to evaluate rescue medication use after initial treatment; to measure total productivity loss following treatment at hourly time points; and to estimate the probability of absenteeism when a migraine begins before or during the workday. The null hypotheses for the secondary endpoints are that no differences will be observed between the results reported by patients treating with SumaRT/Nap and patients treating with triptan monotherapy. The alternative hypotheses are that either treatment is superior to the other for each endpoint.

Conditions

  • Migraine Disorders

Interventions

DRUG

Combination therapy of sumatriptan and naproxen sodium (SumaRT/Nap)

This is an observational study and patients were prescribed this medication before study start

DRUG

Triptan monotherapy

This is an observational study and patients reported a previous triptan monotherapy prescription. Drugs of interested included naratriptan, sumatriptan, rizatriptan, frovatriptan, almotriptan, eletriptan, zolmitriptan

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-10-31
Completion
2011-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01381497 on ClinicalTrials.gov