Impact of Migraine on Work Productivity in Patients Treated With a Combination Product Containing Sumatriptan and Naproxen Sodium or Triptan Monotherapy
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|ClinicalTrials.gov Identifier: NCT01381497|
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : August 27, 2012
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.
|Condition or disease||Intervention/treatment|
|Migraine Disorders||Drug: Combination therapy of sumatriptan and naproxen sodium (SumaRT/Nap) Drug: Triptan monotherapy|
|Study Type :||Observational|
|Actual Enrollment :||1 participants|
|Official Title:||Impact of Migraine on Work Productivity in Patients Treated With a Combination Product Containing Sumatriptan and Naproxen Sodium or Triptan Monotherapy|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
Employed migraine sufferers
Diagnosed adult migraine sufferers who are employed at least 30 hours per week during a daytime shift
Drug: Combination therapy of sumatriptan and naproxen sodium (SumaRT/Nap)
This is an observational study and patients were prescribed this medication before study start
Other Name: Treximet®
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
- Total Lost Productivity (absenteeism and presenteeism) measured by Lost Time Equivalents [ Time Frame: Four qualifying migraine attacks must occur within 16 weeks of enrollment. Data collection begins at time of treatment and continues in hourly intervals until the end of the migraine attack or the end of the workday. ]Lost Time Equivalents = hours missed from work + [(100% - % effectiveness while working with symptoms)/100 x hours working with symptoms].
- Percentage of patients returning to normal functioning as measured by the Clinical Disability Questionnaire (CDQ) [ Time Frame: At time of treatment for a qualifying attack and at hourly intervals post treatment until end of migraine attack or end of workday ]The CDQ uses one question to assess ability to perform normal or usual activities. Responses are recorded on a 5-point scale, where 1 is "normal/not impaired", 2 is "mildly impaired", 3 is "moderately impaired", 4 is "severely impaired", and 5 is '"required bedrest". Normal functioning is considered a score of "1"
- Rescue medication [ Time Frame: Rescue medication is prohibited within 2 hours of study treatment administration. Rescue medication use is measured between 2 and 4 hours post treatment ]For patients who need pain relief in addition to the study treatment, rescue medication is allowed and measured. Type of rescue medication will be allowed at the discretion of the investigator and within the guidelines of the package insert for the study medication
- Number of missed work hours and presenteeism hours lost following treatment measured in hours [ Time Frame: At time of treatment for a qualifying attack and hourly intervals post treatment until end of migraine attack or end of workday ]Measured as per the primary endpoint and reported hourly
- Probability of absenteeism during a morning migraine attack [ Time Frame: At time of treatment for a qualifying attack and hourly intervals post treatment until end of migraine attack or end of workday ]A subgroup analysis will be conducted to provide information about the probability that patients will be absent if the migraine onset occurs in the morning
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01381497
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|