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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Oklahoma City, Oklahoma 73112
851
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Oklahoma City, OK
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Atlanta, Georgia 30341
424
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Austell, Georgia 30106
434
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Austell, GA
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Austin, Texas 78705
1064
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Austin, TX
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Braintree, Massachusetts 02184
644
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Braintree, MA
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Burlington, Vermont 05401
590
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Burlington, VT
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Chandler, Arizona 85224
1655
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Chandler, AZ
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Chicago, Illinois 60611
274
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Chicago, IL
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Cleveland, Ohio 44195
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Cleveland, OH
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Colorado Springs, Colorado 80910
1161
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Daytona Beach, Florida 32117
749
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Endwell, New York 13760
393
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Endwell, NY
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Eugene, Oregon 97401
2055
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Eugene, OR
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Fargo, North Dakota 58122
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Fargo, ND
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Fort Wayne, Indiana 46825
136
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Fort Wayne, IN
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Georgetown, Texas 78626
1045
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Georgetown, TX
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Germantown, Tennessee 38138
501
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Germantown, TN
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Hartford, Connecticut 06105
553
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Hartford, CT
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Hollywood, Florida 33021
977
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Hollywood, FL
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Houston, Texas 77030
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Houston, TX
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Irvine, California 92697
1961
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Irvine, CA
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Kalamazoo, Michigan 49007
209
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Kalamazoo, MI
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Las Vegas, Nevada 89102
1759
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Las Vegas, NV
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Little Rock, Arkansas 72205
625
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Little Rock, AR
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Manhasset, New York 11030
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Manlius, New York 13104
420
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Medford, Oregon 97504
2060
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Medford, OR
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Milford, Massachusetts 01757
617
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Milford, MA
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Minneapolis, Minnesota 55404
624
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Minneapolis, MN
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Mount Pleasant, South Carolina 29464
525
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Mount Pleasant, SC
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Nashville, Tennessee 37203
333
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Nashville, TN
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New York, New York 10032
481
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New York, NY
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Newport Beach, California 92663
1967
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Newport Beach, CA
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Palm Beach Gardens, Florida 33410
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Philadelphia, Pennsylvania 19104
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Phoenix, Arizona 85012
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Pittsburgh, Pennsylvania 15213
165
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Salt Lake City, Utah 84132
1511
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San Antonio, Texas 78258
1126
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San Francisco, California 94115
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Santa Monica, California 90404
1984
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Seattle, Washington 98109
2007
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Stamford, Connecticut 06902
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Tulsa, Oklahoma 74105
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Walnut Creek, California 94596
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West Palm Beach, Florida 33409
930
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Westlake Village, California 91361
1999
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Wichita, Kansas 67207
780
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Wichita, KS
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