Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA)

Last updated: January 20, 2017
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

3

Condition

Chronic Pain

Headaches

Severe Premenstrual Symptom

Treatment

N/A

Clinical Study ID

NCT00329355
TRX105852
  • Ages 18-65
  • Female

Study Summary

This study was designed to determine efficacy of TREXIMET (sumatriptan/naproxen sodium), formerly known as TREXIMA compared to placebo for the treatment of a menstrual migraine.

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: 351
Study Start date:
May 01, 2006
Estimated Completion Date:
November 30, 2006

Study Description

A randomized, double-blind, single migraine attack, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and tolerability of TREXIMA* (sumatriptan succinate/naproxen sodium) tablets vs placebo when administered during the mild pain phase of menstrual migraine in women with dysmenorrhea (*TREXIMET)

Connect with a study center

  • GSK Investigational Site

    Chandler, Arizona 85224
    United States

    Site Not Available

  • GSK Investigational Site

    Irvine, California 92618
    United States

    Site Not Available

  • GSK Investigational Site

    Redondo Beach, California 90277
    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

    Boulder, Colorado 80304
    United States

    Site Not Available

  • GSK Investigational Site

    Colorado Springs, Colorado 80909
    United States

    Site Not Available

  • GSK Investigational Site

    Port Orange, Florida 32127
    United States

    Site Not Available

  • GSK Investigational Site

    Sunrise, Florida 33351
    United States

    Site Not Available

  • GSK Investigational Site

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • GSK Investigational Site

    Chicago, Illinois 60614
    United States

    Site Not Available

  • GSK Investigational Site

    South Bend, Indiana 46601
    United States

    Site Not Available

  • GSK Investigational Site

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

  • GSK Investigational Site

    Ann Arbor, Michigan 48104
    United States

    Site Not Available

  • GSK Investigational Site

    Omaha, Nebraska 68134
    United States

    Site Not Available

  • GSK Investigational Site

    Albuquerque, New Mexico 87108
    United States

    Site Not Available

  • GSK Investigational Site

    New York, New York 10021
    United States

    Site Not Available

  • GSK Investigational Site

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • GSK Investigational Site

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • GSK Investigational Site

    Toledo, Ohio 43614-5809
    United States

    Site Not Available

  • GSK Investigational Site

    West Chester, Ohio 45069
    United States

    Site Not Available

  • GSK Investigational Site

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • GSK Investigational Site

    Portland, Oregon 97210
    United States

    Site Not Available

  • GSK Investigational Site

    Carnegie, Pennsylvania 15106
    United States

    Site Not Available

  • GSK Investigational Site

    Philadelphia, Pennsylvania 19114
    United States

    Site Not Available

  • GSK Investigational Site

    Warwick, Rhode Island 02886
    United States

    Site Not Available

  • GSK Investigational Site

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • GSK Investigational Site

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • GSK Investigational Site

    Georgetown, Texas 78626
    United States

    Site Not Available

  • GSK Investigational Site

    Houston, Texas 77054
    United States

    Site Not Available

  • GSK Investigational Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • GSK Investigational Site

    Salt Lake City, Utah 84109
    United States

    Site Not Available

  • GSK Investigational Site

    Seattle, Washington 98195
    United States

    Site Not Available

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