Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks

Migraine 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00240630
• Other study ID #: TRX103632
• Status: Completed
• Phase: Phase 3
• First received: October 14, 2005
• Last updated: April 15, 2015
• Start date: October 2005
• Est. completion date: June 2006

Study information

• Verified date: April 2015
• 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 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 646
• 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
• Migraine Disorders

Intervention

Drug:
• sumatriptan succinate/naproxen sodium
Combination Tablet of Treximet
• placebo
placebo to match

Locations

Country	Name	City	State
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Austell	Georgia
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Braintree	Massachusetts
United States	GSK Investigational Site	Burlington	Vermont
United States	GSK Investigational Site	Chandler	Arizona
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Colorado Springs	Colorado
United States	GSK Investigational Site	Daytona Beach	Florida
United States	GSK Investigational Site	Endwell	New York
United States	GSK Investigational Site	Eugene	Oregon
United States	GSK Investigational Site	Fargo	North Dakota
United States	GSK Investigational Site	Fort Wayne	Indiana
United States	GSK Investigational Site	Georgetown	Texas
United States	GSK Investigational Site	Germantown	Tennessee
United States	GSK Investigational Site	Hartford	Connecticut
United States	GSK Investigational Site	Hollywood	Florida
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Irvine	California
United States	GSK Investigational Site	Kalamazoo	Michigan
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Manhasset	New York
United States	GSK Investigational Site	Manlius	New York
United States	GSK Investigational Site	Medford	Oregon
United States	GSK Investigational Site	Milford	Massachusetts
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Mount Pleasant	South Carolina
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Newport Beach	California
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Palm Beach Gardens	Florida
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	Santa Monica	California
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Stamford	Connecticut
United States	GSK Investigational Site	Tulsa	Oklahoma
United States	GSK Investigational Site	Walnut Creek	California
United States	GSK Investigational Site	West Palm Beach	Florida
United States	GSK Investigational Site	Westlake Village	California
United States	GSK Investigational Site	Wichita	Kansas

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 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