TREXIMA For Menstrual Migraine in Women With Dysmenorrhea

Condition(s) targeted: Migraine

Intervention: sumatriptan succinate/naproxen sodium (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pozen

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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

Official title: 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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Score on a migraine pain scale at 2 hours through 48 hours for a single menstrual migraine attack

Secondary outcome: Freedom from all migraine pain and symptoms, satisfaction, presence or absence of neck pain/discomfort, sinus pain/pressure, menstrual symptoms, recurrence of head pain, safety and tolerability

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Female.

Criteria:

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 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.

GSK Clinical Trials Call Center, Mesa, Arizona 85201, United States

Little Rock Family Practice Clinic, Little Rock, Arizona 72205, United States

GSK Clinical Trials Call Center, San Diego, California 92128, United States

GSK Clinical Trials Call Center, San Fransisco, California 94102, United States

GSK Clinical Trials Call Center, Newport Beach, California 92660, United States

GSK Clinical Trials Call Center, Stamford, Connecticut 06902, United States

GSK Clinical Trials Call Center, Ft. Lauderdale, Florida 33328, United States

GSK Clinical Trials Call Center, Miami, Florida 33308, United States

GSK Clinical Trials Call Center, Atlanta, Georgia 30342, United States

GSK Clinical Trials Call Center, Decatur, Georgia 30033, United States

GSK Clinical Trials Call Center, Wichitia, Kansas 67207, United States

GSK Clinical Trials Call Center, North Dartmouth, Massachusetts 02747, United States

GSK Clinical Trials Call Center, Milford, Massachusetts 01757, United States

GSK Clinical Trials Call Center, Detroit, Michigan 48201, United States

GSK Clinical Trials Call Center, Springfield, Missouri 87102, United States

GSK Clinical Trials Call Center, St. Louis, Missouri 63141, United States

GSK Clinical Trials Call Center, Moorestown, New Jersey 08057, United States

GSK Clinical Trials Call Center, Albuquerque, New Mexico 87102, United States

GSK Clinical Trials Call Center, Albany, New York 12206, United States

GSK Clinical Trials Call Center, Rochester, New York 14609, United States

GSK Clinical Trials Center, Greensboro, North Carolina 27401, United States

GSK Clinical Trials Call Center, Westerville, Ohio 43081, United States

GSK Clinical Trials Call Center, Cleveland, Ohio 44195, United States

GSK Clinical Trials Call Center, Eugene, Oregon 15236, United States

GSK Clinical Trials Center, Pittsburgh, Pennsylvania 15236, United States

GSK Clinical Trials Call Center, Greer, South Carolina 29651, United States

GSK Clinical Trials Call Center, Memphis, Tennessee 38018, United States

GSK Clinical Trials Call Center, Fort Worth, Texas 76104, United States

GSK Clinical Trials Call Center, San Antonio, Texas 78229, United States

GSK Clinical Trials Call Center, Austin, Texas 78705, United States

GSK Clinical Trials Call Center, Salt Lake City, Utah 84121, United States

GSK Clinical Trials Center, Seattle, Washington 98104, United States

GSK Clinical Trials Call Center, Wenatchee, Washington 98801, United States

Starting date: May 2006
Last updated: January 16, 2008