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

Last updated: October 20, 2016
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

3

Condition

Premenstrual Syndrome

Severe Premenstrual Symptom

Migraine (Adult)

Treatment

N/A

Clinical Study ID

NCT00329459
TRX105850
  • Ages 18-65
  • Female

Study Summary

This study was designed to determine efficacy of 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: 320
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 was formerly known as TREXIMA)

Connect with a study center

  • GSK Investigational Site

    Mesa, Arizona 85201
    United States

    Site Not Available

  • GSK Investigational Site

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • GSK Investigational Site

    Fair Oaks, California 95628
    United States

    Site Not Available

  • GSK Investigational Site

    Newport Beach, California 92660
    United States

    Site Not Available

  • GSK Investigational Site

    San Diego, California 92128
    United States

    Site Not Available

  • GSK Investigational Site

    San Francisco, California 94102
    United States

    Site Not Available

  • GSK Investigational Site

    Stamford, Connecticut 06902
    United States

    Site Not Available

  • GSK Investigational Site

    Fort Lauderdale, Florida 33328
    United States

    Site Not Available

  • GSK Investigational Site

    Miami, Florida 33173
    United States

    Site Not Available

  • GSK Investigational Site

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • GSK Investigational Site

    Wichita, Kansas 67207
    United States

    Site Not Available

  • GSK Investigational Site

    Milford, Massachusetts 01757
    United States

    Site Not Available

  • GSK Investigational Site

    North Dartmouth, Massachusetts 02747
    United States

    Site Not Available

  • GSK Investigational Site

    Detroit, Michigan 48201
    United States

    Site Not Available

  • GSK Investigational Site

    Springfield, Missouri 65804
    United States

    Site Not Available

  • GSK Investigational Site

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • GSK Investigational Site

    Moorestown, New Jersey 08057
    United States

    Site Not Available

  • GSK Investigational Site

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • GSK Investigational Site

    Albany, New York 12206
    United States

    Site Not Available

  • GSK Investigational Site

    Plainview, New York 11803
    United States

    Site Not Available

  • GSK Investigational Site

    Rochester, New York 14609
    United States

    Site Not Available

  • GSK Investigational Site

    Greensboro, North Carolina 27401
    United States

    Site Not Available

  • GSK Investigational Site

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • GSK Investigational Site

    Independence, Ohio 44131
    United States

    Site Not Available

  • GSK Investigational Site

    Westerville, Ohio 43081
    United States

    Site Not Available

  • GSK Investigational Site

    Eugene, Oregon 97401
    United States

    Site Not Available

  • GSK Investigational Site

    Pittsburgh, Pennsylvania 15236
    United States

    Site Not Available

  • GSK Investigational Site

    Greer, South Carolina 29651
    United States

    Site Not Available

  • GSK Investigational Site

    Memphis, Tennessee 38018
    United States

    Site Not Available

  • GSK Investigational Site

    Austin, Texas 78705
    United States

    Site Not Available

  • GSK Investigational Site

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • GSK Investigational Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • GSK Investigational Site

    Salt Lake City, Utah 84121
    United States

    Site Not Available

  • GSK Investigational Site

    Wenatchee, Washington 98801
    United States

    Site Not Available

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