Migraine Disorders Clinical Trial
Official title:
A Randomized, Double-blind, Multi-center, Placebo-controlled, Cross-over Study to Determine the Consistency of Response for Trexima* (Sumatriptan 85mg/Naproxen Sodium 500mg) Administered During the Mild Pain Phase for the Acute Treatment of Multiple Migraine Attacks (*Treximet)
Verified date | October 2016 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 623 |
Est. completion date | June 2006 |
Est. primary completion date | June 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - At least a 6 month history of physician diagnosed migraine and typically experiences 2-6 migraine attacks per month. - 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: - Pregnant and/or nursing mother. - 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. |
Country | Name | City | State |
---|---|---|---|
United States | GSK Investigational Site | Albany | New York |
United States | GSK Investigational Site | Albuquerque | New Mexico |
United States | GSK Investigational Site | Anderson | South Carolina |
United States | GSK Investigational Site | Ann Arbor | Michigan |
United States | GSK Investigational Site | Anniston | Alabama |
United States | GSK Investigational Site | Atlanta | Georgia |
United States | GSK Investigational Site | Avon | Connecticut |
United States | GSK Investigational Site | Baton Rouge | Louisiana |
United States | GSK Investigational Site | Boulder | Colorado |
United States | GSK Investigational Site | Bristol | Tennessee |
United States | GSK Investigational Site | Bronx | New York |
United States | GSK Investigational Site | Chapel Hill | North Carolina |
United States | GSK Investigational Site | Chicago | Illinois |
United States | GSK Investigational Site | Clarksville | Tennessee |
United States | GSK Investigational Site | Concinnati | Ohio |
United States | GSK Investigational Site | Decatur | Georgia |
United States | GSK Investigational Site | Eugene | Oregon |
United States | GSK Investigational Site | Evansville | Indiana |
United States | GSK Investigational Site | Fort Worth | Texas |
United States | GSK Investigational Site | Greensboro | North Carolina |
United States | GSK Investigational Site | Hot Springs | Arkansas |
United States | GSK Investigational Site | Irvine | California |
United States | GSK Investigational Site | Memphis | Tennessee |
United States | GSK Investigational Site | Mesa | Arizona |
United States | GSK Investigational Site | Miami | Florida |
United States | GSK Investigational Site | Moorestown | New Jersey |
United States | GSK Investigational Site | New York | New York |
United States | GSK Investigational Site | Oceanside | California |
United States | GSK Investigational Site | Oklahoma City | Oklahoma |
United States | GSK Investigational Site | Pembroke Pines | Florida |
United States | GSK Investigational Site | Philadelphia | Pennsylvania |
United States | GSK Investigational Site | Phoenix | Arizona |
United States | GSK Investigational Site | Plainview | New York |
United States | GSK Investigational Site | Raleigh | North Carolina |
United States | GSK Investigational Site | Rochester | New York |
United States | GSK Investigational Site | Rome | Georgia |
United States | GSK Investigational Site | Salem | Oregon |
United States | GSK Investigational Site | Salt Lake City | Utah |
United States | GSK Investigational Site | San Antonio | Texas |
United States | GSK Investigational Site | San Diego | California |
United States | GSK Investigational Site | San Diego | California |
United States | GSK Investigational Site | Seattle | Washington |
United States | GSK Investigational Site | South Daytona | Florida |
United States | GSK Investigational Site | St. Louis | Missouri |
United States | GSK Investigational Site | St. Louis Park | Minnesota |
United States | GSK Investigational Site | Stuart | Florida |
United States | GSK Investigational Site | Tacoma | Washington |
United States | GSK Investigational Site | Tuscaloosa | Alabama |
United States | GSK Investigational Site | Valley Stream | New York |
United States | GSK Investigational Site | Wenatchee | Washington |
United States | GSK Investigational Site | West Chester | Ohio |
United States | GSK Investigational Site | Westerville | Ohio |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Score on a 4 pt migraine pain scale for multiple migraine attacks | 2 to 24 hours | ||
Secondary | 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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