Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA)
NCT ID: NCT00329355
Last Updated: 2017-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
351 participants
INTERVENTIONAL
2006-05-31
2006-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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sumatriptan succinate/naproxen sodium
Eligibility Criteria
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Inclusion Criteria
* Typically experiences moderate to severe migraine pain preceded by a mild pain phase
* Differentiate between mild migraine pain and other headache types
* Women of childbearing potential must be on adequate contraception
Exclusion Criteria
* History of cardiovascular disease
* Uncontrolled hypertension
* Basilar or Hemiplegic migraine
* History of stroke or transient ischemic attacks (TIA)
* History of epilepsy or treated with anti-epileptics within past 5 years
* Impaired hepatic or renal function
* History of gastrointestinal bleeding or ulceration
* Allergy or hypersensitivity to aspirin or any other NSAID
* Allergy or hypersensitivity to triptans
* Participated in an investigational drug trial in the previous 4 weeks
18 Years
65 Years
FEMALE
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Chandler, Arizona, United States
GSK Investigational Site
Irvine, California, United States
GSK Investigational Site
Redondo Beach, California, United States
GSK Investigational Site
San Francisco, California, United States
GSK Investigational Site
Santa Monica, California, United States
GSK Investigational Site
Boulder, Colorado, United States
GSK Investigational Site
Colorado Springs, Colorado, United States
GSK Investigational Site
Port Orange, Florida, United States
GSK Investigational Site
Sunrise, Florida, United States
GSK Investigational Site
West Palm Beach, Florida, United States
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
South Bend, Indiana, United States
GSK Investigational Site
Baton Rouge, Louisiana, United States
GSK Investigational Site
Ann Arbor, Michigan, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Albuquerque, New Mexico, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Winston-Salem, North Carolina, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Toledo, Ohio, United States
GSK Investigational Site
West Chester, Ohio, United States
GSK Investigational Site
Oklahoma City, Oklahoma, United States
GSK Investigational Site
Portland, Oregon, United States
GSK Investigational Site
Carnegie, Pennsylvania, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Warwick, Rhode Island, United States
GSK Investigational Site
Mt. Pleasant, South Carolina, United States
GSK Investigational Site
Nashville, Tennessee, United States
GSK Investigational Site
Georgetown, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Salt Lake City, Utah, United States
GSK Investigational Site
Seattle, Washington, United States
Countries
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References
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Durham PL, Vause CV, Derosier F, McDonald S, Cady R, Martin V. Changes in salivary prostaglandin levels during menstrual migraine with associated dysmenorrhea. Headache. 2010 May;50(5):844-51. doi: 10.1111/j.1526-4610.2010.01657.x. Epub 2010 Mar 26.
Mannix LK, Martin VT, Cady RK, Diamond ML, Lener SE, White JD, Derosier FJ, McDonald SA. Combination treatment for menstrual migraine and dysmenorrhea using sumatriptan-naproxen: two randomized controlled trials. Obstet Gynecol. 2009 Jul;114(1):106-113. doi: 10.1097/AOG.0b013e3181a98e4d.
Martin VT, Ballard J, Diamond MP, Mannix LK, Derosier FJ, Lener SE, Krishen A, McDonald SA. Relief of menstrual symptoms and migraine with a single-tablet formulation of sumatriptan and naproxen sodium. J Womens Health (Larchmt). 2014 May;23(5):389-96. doi: 10.1089/jwh.2013.4577. Epub 2014 Feb 28.
Cady RK, Diamond ML, Diamond MP, Ballard JE, Lener ME, Dorner DP, Derosier FJ, McDonald SA, White J, Runken MC. Sumatriptan-naproxen sodium for menstrual migraine and dysmenorrhea: satisfaction, productivity, and functional disability outcomes. Headache. 2011 May;51(5):664-73. doi: 10.1111/j.1526-4610.2011.01894.x.
Study Documents
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Document Type: Annotated Case Report Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Other Identifiers
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TRX105852
Identifier Type: -
Identifier Source: org_study_id
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