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

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ClinicalTrials.gov Identifier: NCT01086358
Recruitment Status : Completed
First Posted : March 15, 2010
Results First Posted : May 1, 2018
Last Update Posted : May 1, 2018
Sponsor:
Collaborators:
GlaxoSmithKline
Pernix Theraputics LLC
Information provided by (Responsible Party):
Jennifer Kriegler, MD, The Cleveland Clinic

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Workplace Migraine Treatment Drug: Triptan Drug: Treximet 85Mg-500Mg Tablet Phase 4

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This was a randomized, open-label, 6-attack (3-attacks per arm) crossover design in which subjects were randomized to threat their first 3 workplace migraines with sumatriptan/naproxen sodium or with their usual triptan monotherapy before treating their subsequent 3 workplace migraines with the opposite medication.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Single Center Randomized Open-Label Two Arm Crossover Study of Subject Productivity Improvement and Satisfaction With Migraine Treatment Using Treximet vs Usual Triptan
Actual Study Start Date : September 2009
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

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 Name: 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 Name: Sumatriptan 85 mg plus naproxen sodium 500 mg




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT01086358


Locations
United States, Ohio
Cleveland Clinic, 9500 Euclid Avenue, C-21
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
GlaxoSmithKline
Pernix Theraputics LLC
Investigators
Principal Investigator: Jennifer S Kriegler, MD The Cleveland Clinic
  Study Documents (Full-Text)

Documents provided by Jennifer Kriegler, MD, The Cleveland Clinic:
Informed Consent Form  [PDF] November 4, 2015


Publications:
Responsible Party: Jennifer Kriegler, MD, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01086358     History of Changes
Other Study ID Numbers: 09-602
First Posted: March 15, 2010    Key Record Dates
Results First Posted: May 1, 2018
Last Update Posted: May 1, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data (IPD) available to other researchers.

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Jennifer Kriegler, MD, The Cleveland Clinic:
Productivity
Migraine
Treximet
Triptan

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Naproxen
Naratriptan
Sumatriptan
Zolmitriptan
Rizatriptan
Eletriptan
Almotriptan
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents