Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response?

March 29, 2018 updated by: Jennifer Kriegler, MD, The Cleveland Clinic

A Single Center Randomized Open-Label Two Arm Crossover Study of Subject Productivity Improvement and Satisfaction With Migraine Treatment Using Treximet vs Usual Triptan

Researchers want to learn about work productivity after treatment of a migraine headache with your usual migraine medication as compared to your work productivity after treatment with Treximet.

During this research subjects will take Treximet to treat 3 workday migraine attacks. For a second part of the research subjects will take their usual prescribed medication for 3 workday migraine attacks. The subjects will complete questionnaires after treating each migraine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A subject who is identified for study participation will participate in the screening and enrollment visit which determines the migraine treatment arm to which the subject will be randomized first. The subject will have a physical exam, vital signs recorded, health and medication questions asked, questionnaires completed and a headache diary explained and dispensed to the subject. If the subject is randomized to the Treximet treatment arm during the first part of the study, Treximet will be dispensed for use in treating workday migraines.

The subject will call the study coordinator after treating a workday migraine and will report information about the migraine to the coordinator. When the subject has treated and reported on 3 migraines, the interim visit will be scheduled. The subject will bring the study diary and Treximet containers (if this was the arm the subject completed)to this visit. The subject will be asked about adverse events and medication changes as well as confirmation and review of the completed questionnaires and diaries from the prior weeks of study participation. The subject will be given new diaries and questionnaires (and Treximet to use if usual prescribed triptan was the treatment in the first arm) and repeat the activities to treat 3 more workday migraines.

When the subject has notified the study coordinator about treating the 3rd workday migraine in this part of the study, the subject will be scheduled for the final study visit. The subject will bring the completed migraine diaries, completed questionnaires (and Treximet bottles if used during this arm) to the study visit. The subject will have the diaries and questionnaires reviewed, be asked about adverse events and medication changes and complete the final study questionnaires at this visit.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic, 9500 Euclid Avenue, C-21

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • episodic migraine diagnosis
  • age 18 or older
  • currently using a triptan as primary migraine monotherapy
  • currently employed
  • if of childbearing potential, willing to prevent pregnancy during study participation
  • able to understand and consent to study participation

Exclusion Criteria:

  • younger than age 18
  • not having episodic migraine diagnosis
  • not using a triptan as primary migraine monotherapy
  • not currently employed
  • pregnant or nursing or unwilling to prevent pregnancy during study participation
  • unable to understand and consent to study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Triptan
Arm 1 subjects began with their prescribed triptan
Drug: Triptan
Usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan
Other Names:
  • Sumatriptan,rizatriptan,naratriptan,almotriptan,eletriptan,zolmitriptan
Active Comparator: Treximet 85Mg-500Mg Tablet
Arm 2 subjects began with Treximet (sumatriptan 85 mg/naproxen sodium 500 mg)
Drug: Treximet 85Mg-500Mg Tablet
Treximet is 85 mg sumatriptan plus 500 mg naproxen sodium
Other Names:
  • Sumatriptan 85 mg plus naproxen sodium 500 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Workplace Productivity and Activity Impairment Scale (WPAI).
Time Frame: 6 months
The primary outcome measure was lost productivity (workplace productivity + non-workplace activity time) as measured by a variant of the Work Productivity and Activity Impairment Scale (WPAI) at 6 months. The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The unit of analysis is hours lost. The higher the score the greater impact on productivity. The range depends on the length of the attack, but in the sample among all observed attacks, lost work productivity ranged from 0-10.5 hours, while lost non-workplace activity time ranged from 0 to 8.95 hours. The total lost productivity is the sum of lost work productivity and lost non-workplace activity time.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lost Workplace Productivity
Time Frame: 6 months
This outcome measure was lost workplace productivity as measured by a variant of the Work Productivity and Activity Impairment Scale (WPAI) at 6 months.The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The unit of analysis is hours lost. The higher the score the greater impact on productivity. The range depends on the length of the attack, but in the sample among all observed attacks, lost work productivity ranged from 0-10.5 hours, while lost non-workplace activity time ranged from 0 to 8.95 hours. The total lost productivity is the sum of lost work productivity and lost non-workplace activity time.
6 months
Lost Activity Time
Time Frame: 6 Months
This outcome measure was lost activity time as measured by a variant of the Work Productivity and Activity Impairment Scale (WPAI) at 6 months.The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The unit of analysis is hours lost. The higher the score the greater impact on productivity. The range depends on the length of the attack, but in the sample among all observed attacks, lost work productivity ranged from 0-10.5 hours, while lost non-workplace activity time ranged from 0 to 8.95 hours. The total lost productivity is the sum of lost work productivity and lost non-workplace activity time.
6 Months
Favorable Response on Migraine-ACT
Time Frame: 6 months
The Migraine-ACT is a 4-item scale with yes/no responses. A score of 3 or more is considered favorable. The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The Migraine-ACT is reported as a binary measure (3 or more positive responses). The outcome presented included the percentage with a score of 3 or more, and the Odds ratio comparing the two treatments.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

GlaxoSmithKline
Currax Pharmaceuticals

Investigators

  • Principal Investigator: Jennifer S Kriegler, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2009

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

March 11, 2010

First Submitted That Met QC Criteria

March 11, 2010

First Posted (Estimate)

March 15, 2010

Study Record Updates

Last Update Posted (Actual)

May 1, 2018

Last Update Submitted That Met QC Criteria

March 29, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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