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This study was designed to determine efficacy of TREXIMET (sumatriptan/naproxen sodium), formerly known as TREXIMA compared to placebo for the treatment of a menstrual migraine.
A randomized, double-blind, single migraine attack, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and tolerability of TREXIMA* (sumatriptan succinate/naproxen sodium) tablets vs placebo when administered during the mild pain phase of menstrual migraine in women with dysmenorrhea (*TREXIMET)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sumatriptan succinate/naproxen sodium | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Score on a 4-pt migraine pain scale for a single menstrual migraine attack | 2 to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from all migraine pain and symptoms, satisfaction, presence or absence of neck pain/discomfort, sinus pain/pressure, menstrual symptoms, recurrence of head pain, safety and tolerability | 2 to 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Chandler | Arizona | 85224 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20353434 | Result | 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. | |
| 19546766 | Result | 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. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| TRX105852 | Annotated Case Report Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| Irvine |
| California |
| 92618 |
| United States |
| GSK Investigational Site | Redondo Beach | California | 90277 | United States |
| GSK Investigational Site | San Francisco | California | 94109 | United States |
| GSK Investigational Site | Santa Monica | California | 90404 | United States |
| GSK Investigational Site | Boulder | Colorado | 80304 | United States |
| GSK Investigational Site | Colorado Springs | Colorado | 80909 | United States |
| GSK Investigational Site | Port Orange | Florida | 32127 | United States |
| GSK Investigational Site | Sunrise | Florida | 33351 | United States |
| GSK Investigational Site | West Palm Beach | Florida | 33407 | United States |
| GSK Investigational Site | Chicago | Illinois | 60614 | United States |
| GSK Investigational Site | South Bend | Indiana | 46601 | United States |
| GSK Investigational Site | Baton Rouge | Louisiana | 70808 | United States |
| GSK Investigational Site | Ann Arbor | Michigan | 48104 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68134 | United States |
| GSK Investigational Site | Albuquerque | New Mexico | 87108 | United States |
| GSK Investigational Site | New York | New York | 10021 | United States |
| GSK Investigational Site | New York | New York | 10022 | United States |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45245 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45267 | United States |
| GSK Investigational Site | Toledo | Ohio | 43614-5809 | United States |
| GSK Investigational Site | West Chester | Ohio | 45069 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73104 | United States |
| GSK Investigational Site | Portland | Oregon | 97210 | United States |
| GSK Investigational Site | Carnegie | Pennsylvania | 15106 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19114 | United States |
| GSK Investigational Site | Warwick | Rhode Island | 02886 | United States |
| GSK Investigational Site | Mt. Pleasant | South Carolina | 29464 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203 | United States |
| GSK Investigational Site | Georgetown | Texas | 78626 | United States |
| GSK Investigational Site | Houston | Texas | 77054 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84109 | United States |
| GSK Investigational Site | Seattle | Washington | 98195 | United States |
| 24579886 | Derived | 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. |
| 21521204 | Derived | 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. |
For additional information about this study please refer to the GSK Clinical Study Register |
| TRX105852 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TRX105852 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TRX105852 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TRX105852 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TRX105852 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TRX105852 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D017699 | Pelvic Pain |
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| ID | Term |
|---|---|
| D018170 | Sumatriptan |
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
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