Study Of Treximet, Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 65
Updated:10/14/2017
Start Date:October 2005
End Date:June 2006

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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 (*Treximet)

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


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.
We found this trial at
51
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San Diego, California 92111
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San Diego, CA
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Albany, New York 12206
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Albuquerque, New Mexico 87109
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Anderson, South Carolina 29621
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Ann Arbor, Michigan 48109
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Anniston, Alabama 36207
462
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Atlanta, Georgia 30341
424
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Avon, Connecticut 06001
547
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Avon, CT
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Baton Rouge, Louisiana 70809
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Boulder, Colorado 80304
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Bristol, Tennessee 37620
237
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Bronx, New York 10461
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Chapel Hill, North Carolina 27599
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Chicago, Illinois 60611
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Chicago, IL
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Clarksville, Tennessee 37043
334
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Concinnati, Ohio 45219
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Decatur, Georgia 30033
430
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Eugene, Oregon 97401
2055
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Evansville, Indiana 47714
278
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Fort Worth, Texas 76104
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Greensboro, North Carolina 27403
320
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Hot Springs, Arkansas 71913
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Irvine, California 92697
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Memphis, Tennessee 38120
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Mesa, Arizona 85206
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Miami, Florida 33136
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Moorestown, New Jersey 08057
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New York, New York 10032
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Oceanside, California 92056
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Oklahoma City, Oklahoma 73112
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Pembroke Pines, Florida 33028
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Philadelphia, Pennsylvania 19104
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Phoenix, Arizona 85012
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Plainview, New York 11803
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Raleigh, North Carolina 27614
366
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Rochester, New York 14642
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Rome, Georgia 30165
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Salem, Oregon 97301
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Salt Lake City, Utah 84132
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San Antonio, Texas 78258
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Seattle, Washington 98109
2007
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South Daytona, Florida 32119
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St. Louis, Missouri 63110
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St. Louis Park, Minnesota 55426
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Stuart, Florida 34994
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Tacoma, Washington 98405
2013
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Tuscaloosa, Alabama 35401
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Valley Stream, New York 11580
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Wenatchee, Washington 98801
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West Chester, Ohio 45069
90
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Westerville, Ohio 43081
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