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The purpose of this study is to determine the consistency of response for Treximet (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 | Active Comparator | Treximet (sumatriptan/naproxen sodium) formerly known as TREXIMA |
|
| arm 2 | Placebo Comparator | placebo to match |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sumatriptan succinate/naproxen sodium | Drug | comparator |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Score on a 4 pt 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 | Anniston | Alabama | 36207 | 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. |
| 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 |
|---|---|---|---|
| TRX103635 | Individual Participant Data Set | 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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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 19, 2017 | |
| Reset | Jan 24, 2018 | |
| Release | Jan 31, 2018 |
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| Drug |
placebo to match |
|
| Tuscaloosa |
| Alabama |
| 35406 |
| United States |
| GSK Investigational Site | Mesa | Arizona | 85201 | United States |
| GSK Investigational Site | Phoenix | Arizona | 85032 | United States |
| GSK Investigational Site | Hot Springs | Arkansas | 71913 | United States |
| GSK Investigational Site | Irvine | California | 92618 | United States |
| GSK Investigational Site | Oceanside | California | 92056 | United States |
| GSK Investigational Site | San Diego | California | 92108 | United States |
| GSK Investigational Site | San Diego | California | 92128 | United States |
| GSK Investigational Site | Boulder | Colorado | 80304 | United States |
| GSK Investigational Site | Avon | Connecticut | 06001 | United States |
| GSK Investigational Site | Miami | Florida | 33173 | United States |
| GSK Investigational Site | Pembroke Pines | Florida | 33024 | United States |
| GSK Investigational Site | South Daytona | Florida | 32119 | United States |
| GSK Investigational Site | Stuart | Florida | 34996 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30342 | United States |
| GSK Investigational Site | Decatur | Georgia | 30033 | United States |
| GSK Investigational Site | Rome | Georgia | 30165 | United States |
| GSK Investigational Site | Chicago | Illinois | 60607 | United States |
| GSK Investigational Site | Evansville | Indiana | 47712 | United States |
| GSK Investigational Site | Baton Rouge | Louisiana | 70808 | United States |
| GSK Investigational Site | Ann Arbor | Michigan | 48104 | United States |
| GSK Investigational Site | Saint Louis Park | Minnesota | 55426 | United States |
| GSK Investigational Site | St Louis | Missouri | 63141 | United States |
| GSK Investigational Site | Moorestown | New Jersey | 08057 | United States |
| GSK Investigational Site | Albuquerque | New Mexico | 87108 | United States |
| GSK Investigational Site | Albany | New York | 12206 | United States |
| GSK Investigational Site | New York | New York | 10021 | United States |
| GSK Investigational Site | Plainview | New York | 11803 | United States |
| GSK Investigational Site | Rochester | New York | 14609 | United States |
| GSK Investigational Site | The Bronx | New York | 10467 | United States |
| GSK Investigational Site | Valley Stream | New York | 11580 | United States |
| GSK Investigational Site | Chapel Hill | North Carolina | 27599 | United States |
| GSK Investigational Site | Greensboro | North Carolina | 27401 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27609 | United States |
| GSK Investigational Site | Concinnati | Ohio | 45219 | United States |
| GSK Investigational Site | West Chester | Ohio | 45069 | United States |
| GSK Investigational Site | Westerville | Ohio | 43081 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73104 | United States |
| GSK Investigational Site | Eugene | Oregon | 97401 | United States |
| GSK Investigational Site | Salem | Oregon | 97301 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19114 | United States |
| GSK Investigational Site | Anderson | South Carolina | 29621 | United States |
| GSK Investigational Site | Bristol | Tennessee | 37620 | United States |
| GSK Investigational Site | Clarksville | Tennessee | 37043 | United States |
| GSK Investigational Site | Memphis | Tennessee | 38105 | United States |
| GSK Investigational Site | Fort Worth | Texas | 76135 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84121 | United States |
| GSK Investigational Site | Seattle | Washington | 98195 | United States |
| GSK Investigational Site | Tacoma | Washington | 98405 | United States |
| GSK Investigational Site | Wenatchee | Washington | 98801 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| TRX103635 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TRX103635 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TRX103635 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TRX103635 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TRX103635 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TRX103635 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Unrelease | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 19, 2017 | Jan 24, 2018 | |||
| Jan 31, 2018 | 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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