Study Of Trexima In The Acute Treatment Of Multiple Migraine Attacks

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

The purpose of this study is to determine the consistency of response for Trexima when treating four acute migraine attacks at the mild pain phase and within 1 hour of onset of head pain.

Official title: A Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Cross-Over Study to Determine the Consistency of Response for Trexima (Sumatriptan 85mg/Naproxen Sodium 500mg) Administered During the Mild Pain Phase for the Acute Treatment of Multiple Migraine Attacks

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

Primary outcome: Score on a migraine pain scale at 2 hours through 24 hours for multiple migraine attacks

Secondary outcome: Within patient consistency of response, freedom from all migraine pain and symptoms, satisfaction, presence or absence of neck pain/discomfort, sinus pain/pressure, recurrence of head pain, safety and tolerability

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

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, Anniston, Alabama 36207, United States

GSK Clinical Trials Call Center, Tuscaloosa, Alabama 35406, United States

GSK Clinical Trials Call Center, Phoenix, Arizona 85027, United States

GSK Clinical Trials Call Center, Phoenix, Arizona 85032, United States

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

GSK Clinical Trials Call Center, Hot Springs, Arkansas 71913, United States

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

GSK Clinical Trials Call Center, Oceanside, California 92056, United States

GSK Clinical Trials Call Center, Irvine, California 92618, United States

GSK Clinical Trials Call Center, San Diego, California 92108, United States

GSK Clinical Trials Call Center, Boulder, Colorado 80304, United States

GSK Clinical Trials Call Center, Avon, Connecticut 06001, United States

GSK Clinical Trials Call Center, Stuart, Florida 34996, United States

GSK Clinical Trials Call Center, Pembroke Pines, Florida 33024, United States

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

GSK Clinical Trials Call Center, Port Orange, Florida 32127, United States

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

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

GSK Clinical Trials Call Center, Rome, Georgia 30165, United States

GSK Clinical Trials Call Center, Chicago, Illinois 60607, United States

GSK Clinical Trials Call Center, Evansville, Indiana 47712, United States

GSK Clinical Trials Call Center, Baton Rouge, Louisiana 70808, United States

GSK Clinical Trials Call Center, Ann Arbor, Michigan 48104, United States

GSK Clinical Trials Call Center, Minneapolis, Minnesota 55426, United States

GSK Clinical Trials Call Center, St. Louis, Missouri 63141, 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 87108, 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 Call Center, Valley Stream, New York 11580, United States

GSK Clinical Trials Call Center, Bronx, New York 10461, United States

GSK Clinical Trials Call Center, New York, New York 10021, United States

GSK Clinical Trials Call Center, Plainview, New York 11803, United States

GSK Clinical Trials Call Center, Raleigh, North Carolina 27609, United States

GSK Clinical Trials Call Center, Chapel Hill, North Carolina 27599, United States

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

GSK Clinical Trials Call Center, Cincinnati, Ohio 45219, United States

GSK Clinical Trials Call Center, Columbus, Ohio 43205, United States

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

GSK Clinical Trials Call Center, West Chester, Ohio 45069, United States

GSK Clinical Trials Call Center, Oklahoma City, Oklahoma 73104, United States

GSK Clinical Trials Call Center, Eugene, Oregon 97401, United States

GSK Clinical Trials Call Center, Portland, Oregon 97213, United States

GSK Clinical Trials Call Center, Philadelphia, Pennsylvania 19114, United States

GSK Clinical Trials Call Center, Anderson, South Carolina 29621, United States

GSK Clinical Trials Call Center, Bristol, Tennessee 37620, United States

GSK Clinical Trials Call Center, Germantown, Tennessee 38138, United States

GSK Clinical Trials Call Center, Clarksville, Tennessee 37043, United States

GSK Clinical Trials Call Center, San Angelo, Texas 76904, United States

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

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

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

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

GSK Clinical Trials Call Center, Seattle, Washington 98195, United States

GSK Clinical Trials Call Center, Tacoma, Washington 09405, United States

Starting date: September 2005
Last updated: January 16, 2008