Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as TREXIMA, for Menstrual Migraine in Women With Dysmenorrhea

Completed · Phase 3 · Has a placebo group

Conditions studied: Migraine Disorders

In brief

This study was designed to determine efficacy of TREXIMA compared to placebo for the treatment of a menstrual migraine.

Key facts

Study ID

NCT00329459

Run by

GlaxoSmithKline

People needed

320

Starts

2006-05-01

Expected to finish

2006-11-01

Last updated by the study team

2016-10-24

Who can join

Age: 18 and older, up to 65. Sex: female. 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 — Mesa, Arizona, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Fair Oaks, California, United States
• GSK Investigational Site — Newport Beach, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Stamford, Connecticut, United States
• GSK Investigational Site — Fort Lauderdale, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Wichita, Kansas, United States
• GSK Investigational Site — Milford, Massachusetts, United States
• GSK Investigational Site — North Dartmouth, Massachusetts, United States
• GSK Investigational Site — Detroit, Michigan, United States
• GSK Investigational Site — Springfield, Missouri, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Moorestown, New Jersey, United States
• GSK Investigational Site — Albuquerque, New Mexico, United States
• GSK Investigational Site — Albany, New York, United States
• GSK Investigational Site — Plainview, New York, United States
• GSK Investigational Site — Rochester, New York, United States
• GSK Investigational Site — Greensboro, North Carolina, United States
• GSK Investigational Site — Cleveland, Ohio, United States
• GSK Investigational Site — Independence, Ohio, United States
• GSK Investigational Site — Westerville, Ohio, United States

Full record on ClinicalTrials.gov

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