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The purpose of this study is to determine the consistency of response for Treximet (sumatriptan/naproxen sodium), formerly known as Trexima, when treating four acute migraine attacks at the mild pain phase and within 1 hour of onset of head pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Placebo Comparator | placebo to match |
|
| Arm 2 | Experimental | Treximet (sumatriptan/naproxen sodium) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sumatriptan succinate/naproxen sodium | Drug | Combination Tablet of Treximet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Score on a migraine pain scale for multiple migraine attacks | 2 to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Within patient consistency of response, freedom from all migraine pain and symptoms, satisfaction, presence or absence of neck pain/discomfort, sinus pain/pressure, recurrence of head pain, safety and tolerability | 2 to 24 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 |
|---|---|---|---|
| 20855373 | Result | Torgovnick J, Sethi NK, Arsura E. Consistency of response to sumatriptan/naproxen sodium in a placebo-controlled cross-over study. Cephalalgia. 2010 Oct;30(10):1277; author reply 1277-9. doi: 10.1177/0333102409352810. Epub 2010 May 13. No abstract available. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 20, 2017 | |
| Reset | Nov 14, 2017 | |
| Release | Dec 4, 2017 |
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| placebo |
| Drug |
placebo to match |
|
| Phoenix |
| Arizona |
| 85013 |
| United States |
| GSK Investigational Site | Little Rock | Arkansas | 72205 | United States |
| GSK Investigational Site | Irvine | California | 92618 | United States |
| GSK Investigational Site | Newport Beach | California | 92660 | United States |
| GSK Investigational Site | San Francisco | California | 94109 | United States |
| GSK Investigational Site | Santa Monica | California | 90404 | United States |
| GSK Investigational Site | Walnut Creek | California | 94596 | United States |
| GSK Investigational Site | Westlake Village | California | 91361 | United States |
| GSK Investigational Site | Colorado Springs | Colorado | 80904 | United States |
| GSK Investigational Site | Hartford | Connecticut | 06106 | United States |
| GSK Investigational Site | Stamford | Connecticut | 06902 | United States |
| GSK Investigational Site | Daytona Beach | Florida | 32114 | United States |
| GSK Investigational Site | Hollywood | Florida | 33021 | United States |
| GSK Investigational Site | Palm Beach Gardens | Florida | 33410 | United States |
| GSK Investigational Site | West Palm Beach | Florida | 33407 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30308 | United States |
| GSK Investigational Site | Austell | Georgia | 30106 | United States |
| GSK Investigational Site | Chicago | Illinois | 60614 | United States |
| GSK Investigational Site | Fort Wayne | Indiana | 46805 | United States |
| GSK Investigational Site | Wichita | Kansas | 67207 | United States |
| GSK Investigational Site | Braintree | Massachusetts | 02184 | United States |
| GSK Investigational Site | Milford | Massachusetts | 01757 | United States |
| GSK Investigational Site | Kalamazoo | Michigan | 49009 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55422 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89146 | United States |
| GSK Investigational Site | Endwell | New York | 13760 | United States |
| GSK Investigational Site | Manhasset | New York | 11030 | United States |
| GSK Investigational Site | Manlius | New York | 13104 | United States |
| GSK Investigational Site | New York | New York | 10022 | United States |
| GSK Investigational Site | Fargo | North Dakota | 58122 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44195 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| GSK Investigational Site | Tulsa | Oklahoma | 74136 | United States |
| GSK Investigational Site | Eugene | Oregon | 97401 | United States |
| GSK Investigational Site | Medford | Oregon | 97504-8456 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107-2568 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15236 | United States |
| GSK Investigational Site | Mt. Pleasant | South Carolina | 29464 | United States |
| GSK Investigational Site | Germantown | Tennessee | 38138 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203 | United States |
| GSK Investigational Site | Austin | Texas | 78705 | United States |
| GSK Investigational Site | Georgetown | Texas | 78626 | United States |
| GSK Investigational Site | Houston | Texas | 77004 | United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | San Antonio | Texas | 78258 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84107 | United States |
| GSK Investigational Site | Burlington | Vermont | 05405 | United States |
| GSK Investigational Site | Seattle | Washington | 98122 | United States |
| Unrelease | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 20, 2017 | Nov 14, 2017 | |||
| Dec 4, 2017 | Aug 15, 2018 |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001519 | Behavior |
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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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