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

Last updated: April 15, 2015
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

3

Condition

Migraine (Adult)

Oral Facial Pain

Pain

Treatment

N/A

Clinical Study ID

NCT00240630
TRX103632
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 646
Study Start date:
October 01, 2005
Estimated Completion Date:
June 30, 2006

Connect with a study center

  • GSK Investigational Site

    Chandler, Arizona 85224
    United States

    Site Not Available

  • GSK Investigational Site

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • GSK Investigational Site

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • GSK Investigational Site

    Irvine, California 92618
    United States

    Site Not Available

  • GSK Investigational Site

    Newport Beach, California 92660
    United States

    Site Not Available

  • GSK Investigational Site

    San Francisco, California 94109
    United States

    Site Not Available

  • GSK Investigational Site

    Santa Monica, California 90404
    United States

    Site Not Available

  • GSK Investigational Site

    Walnut Creek, California 94596
    United States

    Site Not Available

  • GSK Investigational Site

    Westlake Village, California 91361
    United States

    Site Not Available

  • GSK Investigational Site

    Colorado Springs, Colorado 80904
    United States

    Site Not Available

  • GSK Investigational Site

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • GSK Investigational Site

    Stamford, Connecticut 06902
    United States

    Site Not Available

  • GSK Investigational Site

    Daytona Beach, Florida 32114
    United States

    Site Not Available

  • GSK Investigational Site

    Hollywood, Florida 33021
    United States

    Site Not Available

  • GSK Investigational Site

    Palm Beach Gardens, Florida 33410
    United States

    Site Not Available

  • GSK Investigational Site

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • GSK Investigational Site

    Atlanta, Georgia 30308
    United States

    Site Not Available

  • GSK Investigational Site

    Austell, Georgia 30106
    United States

    Site Not Available

  • GSK Investigational Site

    Chicago, Illinois 60614
    United States

    Site Not Available

  • GSK Investigational Site

    Fort Wayne, Indiana 46805
    United States

    Site Not Available

  • GSK Investigational Site

    Wichita, Kansas 67207
    United States

    Site Not Available

  • GSK Investigational Site

    Braintree, Massachusetts 02184
    United States

    Site Not Available

  • GSK Investigational Site

    Milford, Massachusetts 01757
    United States

    Site Not Available

  • GSK Investigational Site

    Kalamazoo, Michigan 49009
    United States

    Site Not Available

  • GSK Investigational Site

    Minneapolis, Minnesota 55422
    United States

    Site Not Available

  • GSK Investigational Site

    Las Vegas, Nevada 89146
    United States

    Site Not Available

  • GSK Investigational Site

    Endwell, New York 13760
    United States

    Site Not Available

  • GSK Investigational Site

    Manhasset, New York 11030
    United States

    Site Not Available

  • GSK Investigational Site

    Manlius, New York 13104
    United States

    Site Not Available

  • GSK Investigational Site

    New York, New York 10022
    United States

    Site Not Available

  • GSK Investigational Site

    Fargo, North Dakota 58122
    United States

    Site Not Available

  • GSK Investigational Site

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • GSK Investigational Site

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • GSK Investigational Site

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • GSK Investigational Site

    Eugene, Oregon 97401
    United States

    Site Not Available

  • GSK Investigational Site

    Medford, Oregon 97504-8456
    United States

    Site Not Available

  • GSK Investigational Site

    Philadelphia, Pennsylvania 19107-2568
    United States

    Site Not Available

  • GSK Investigational Site

    Pittsburgh, Pennsylvania 15236
    United States

    Site Not Available

  • GSK Investigational Site

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • GSK Investigational Site

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • GSK Investigational Site

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • GSK Investigational Site

    Austin, Texas 78705
    United States

    Site Not Available

  • GSK Investigational Site

    Georgetown, Texas 78626
    United States

    Site Not Available

  • GSK Investigational Site

    Houston, Texas 77004
    United States

    Site Not Available

  • GSK Investigational Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • GSK Investigational Site

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • GSK Investigational Site

    Burlington, Vermont 05405
    United States

    Site Not Available

  • GSK Investigational Site

    Seattle, Washington 98122
    United States

    Site Not Available

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