Study Of Treximet, Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00240617
• Other study ID #: TRX103635
• Status: Completed
• Phase: Phase 3
• First received: October 14, 2005
• Last updated: October 24, 2016
• Start date: October 2005
• Est. completion date: June 2006

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Drug:
• sumatriptan succinate/naproxen sodium
comparator
• placebo
placebo to match

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.