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

Completed · Phase 3 · Has a placebo group

Conditions studied: Migraine Disorders

In brief

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.

Key facts

Study ID

NCT00240617

Run by

GlaxoSmithKline

People needed

623

Starts

2005-10-01

Expected to finish

2006-06-01

Last updated by the study team

2016-10-26

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 — Tuscaloosa, Alabama, United States
• GSK Investigational Site — Mesa, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Hot Springs, Arkansas, United States
• GSK Investigational Site — Irvine, California, United States
• GSK Investigational Site — Oceanside, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Boulder, Colorado, United States
• GSK Investigational Site — Avon, Connecticut, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Pembroke Pines, Florida, United States
• GSK Investigational Site — South Daytona, Florida, United States
• GSK Investigational Site — Stuart, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Decatur, Georgia, United States
• GSK Investigational Site — Rome, Georgia, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Evansville, Indiana, United States
• GSK Investigational Site — Baton Rouge, Louisiana, United States
• GSK Investigational Site — Ann Arbor, Michigan, United States
• GSK Investigational Site — Saint Louis Park, Minnesota, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Moorestown, New Jersey, United States
• GSK Investigational Site — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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