Treximet (Sumatriptan/Naproxen Sodium), 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:12/7/2017
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

The purpose of this study is to determine the consistency of response for Treximet
(sumatriptan/naproxen sodium), 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
48
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Daytona Beach, Florida 32117
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Atlanta, Georgia 30341
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Austell, Georgia 30106
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Austin, Texas 78705
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Braintree, Massachusetts 02184
1446
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Burlington, Vermont 05401
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Chandler, Arizona 85224
846
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Chicago, Illinois 60611
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Cleveland, Ohio 44195
898
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Colorado Springs, Colorado 80910
383
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Endwell, New York 13760
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Eugene, Oregon 97401
1382
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Fargo, North Dakota 58122
635
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Fort Wayne, Indiana 46825
716
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Georgetown, Texas 78626
491
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Germantown, Tennessee 38138
481
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Hartford, Connecticut 06105
1357
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Hollywood, Florida 33021
1310
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Houston, Texas 77030
572
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Irvine, California 92697
1156
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Kalamazoo, Michigan 49007
718
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Las Vegas, Nevada 89102
963
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Little Rock, Arkansas 72205
368
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Manhasset, New York 11030
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Manlius, New York 13104
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Medford, Oregon 97504
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Milford, Massachusetts 01757
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Minneapolis, Minnesota 55404
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Mount Pleasant, South Carolina 29464
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Nashville, Tennessee 37203
618
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New York, New York 10032
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Newport Beach, California 92663
1161
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Oklahoma City, Oklahoma 73112
155
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Palm Beach Gardens, Florida 33410
1275
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Philadelphia, Pennsylvania 19104
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Pittsburgh, Pennsylvania 15213
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Salt Lake City, Utah 84132
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San Antonio, Texas 78258
561
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San Francisco, California 94115
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Westlake Village, California 91361
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Wichita, Kansas 67207
32
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