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

Completed · Phase 3 · Has a placebo group

Conditions studied: Migraine Disorders, Migraine

In brief

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.

Key facts

Study ID

NCT00240630

Run by

GlaxoSmithKline

People needed

646

Starts

2005-10-01

Expected to finish

2006-06-01

Last updated by the study team

2015-04-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Chandler, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Irvine, California, United States
• GSK Investigational Site — Newport Beach, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Santa Monica, California, United States
• GSK Investigational Site — Walnut Creek, California, United States
• GSK Investigational Site — Westlake Village, California, United States
• GSK Investigational Site — Colorado Springs, Colorado, United States
• GSK Investigational Site — Hartford, Connecticut, United States
• GSK Investigational Site — Stamford, Connecticut, United States
• GSK Investigational Site — Daytona Beach, Florida, United States
• GSK Investigational Site — Hollywood, Florida, United States
• GSK Investigational Site — Palm Beach Gardens, Florida, United States
• GSK Investigational Site — West Palm Beach, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Austell, Georgia, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Fort Wayne, Indiana, United States
• GSK Investigational Site — Wichita, Kansas, United States
• GSK Investigational Site — Braintree, Massachusetts, United States
• GSK Investigational Site — Milford, Massachusetts, United States
• GSK Investigational Site — Kalamazoo, Michigan, United States
• GSK Investigational Site — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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