Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response? (TRXvUsualTrptn)
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| First Received Date ICMJE | March 11, 2010 | ||||||||
| Last Updated Date | December 11, 2012 | ||||||||
| Start Date ICMJE | September 2009 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
workplace productivity compared between migraines treated with usual triptan versus migraines treated with Treximet [ Time Frame: about 6 months ] [ Designated as safety issue: No ] WPAI assessment will be completed by the subjects after treatment of each of 6 workplace migraines |
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| Original Primary Outcome Measures ICMJE |
workplace productivity compared between migraines treated with usual triptan versus migraines treated with Treximet [ Designated as safety issue: No ] WPAI assessment will be completed by the subjects after treatment of each of 6 workplace migraines |
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| Change History | Complete list of historical versions of study NCT01086358 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
comparison of patient completeness of response to migraine treatments across 6 treated workplace migraines [ Time Frame: about 6 months ] [ Designated as safety issue: No ] CORS 1 and CORS 2 assessments will be completed for each of 6 treated workplace migraines by each subject |
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| Original Secondary Outcome Measures ICMJE |
comparison of patient completenes of response to migraine treatments across 6 treated workplace migraines [ Designated as safety issue: No ] CORS 1 and CORS 2 assessments will be completed for each of 6 treated workplace migraines by each subject |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response? | ||||||||
| Official Title ICMJE | A Single Center, Randomized, Open-Label, Two Arm Crossover Study of Subject Productivity Improvement and Satisfaction With Migraine Treatment Using Treximet vs Usual Triptan. Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response? | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label |
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| Condition ICMJE | Workplace Migraine Treatment | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01086358 | ||||||||
| Other Study ID Numbers ICMJE | 09-602 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | The Cleveland Clinic | ||||||||
| Study Sponsor ICMJE | The Cleveland Clinic | ||||||||
| Collaborators ICMJE | GlaxoSmithKline | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | The Cleveland Clinic | ||||||||
| Verification Date | December 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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