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Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00240630
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : April 16, 2015
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Migraine Disorders Migraine Drug: sumatriptan succinate/naproxen sodium Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 646 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : October 2005
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Placebo Comparator: Arm 1
placebo to match
Drug: sumatriptan succinate/naproxen sodium
Combination Tablet of Treximet

Experimental: Arm 2
Treximet (sumatriptan/naproxen sodium)
Drug: placebo
placebo to match

Primary Outcome Measures :
  1. Score on a migraine pain scale for multiple migraine attacks [ Time Frame: 2 to 24 hours ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 2 to 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00240630

  Hide Study Locations
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United States, Arizona
GSK Investigational Site
Chandler, Arizona, United States, 85224
GSK Investigational Site
Phoenix, Arizona, United States, 85013
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site
Irvine, California, United States, 92618
GSK Investigational Site
Newport Beach, California, United States, 92660
GSK Investigational Site
San Francisco, California, United States, 94109
GSK Investigational Site
Santa Monica, California, United States, 90404
GSK Investigational Site
Walnut Creek, California, United States, 94596
GSK Investigational Site
Westlake Village, California, United States, 91361
United States, Colorado
GSK Investigational Site
Colorado Springs, Colorado, United States, 80904
United States, Connecticut
GSK Investigational Site
Hartford, Connecticut, United States, 06106
GSK Investigational Site
Stamford, Connecticut, United States, 06902
United States, Florida
GSK Investigational Site
Daytona Beach, Florida, United States, 32114
GSK Investigational Site
Hollywood, Florida, United States, 33021
GSK Investigational Site
Palm Beach Gardens, Florida, United States, 33410
GSK Investigational Site
West Palm Beach, Florida, United States, 33407
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30308
GSK Investigational Site
Austell, Georgia, United States, 30106
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60614
United States, Indiana
GSK Investigational Site
Fort Wayne, Indiana, United States, 46805
United States, Kansas
GSK Investigational Site
Wichita, Kansas, United States, 67207
United States, Massachusetts
GSK Investigational Site
Braintree, Massachusetts, United States, 02184
GSK Investigational Site
Milford, Massachusetts, United States, 01757
United States, Michigan
GSK Investigational Site
Kalamazoo, Michigan, United States, 49009
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55422
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89146
United States, New York
GSK Investigational Site
Endwell, New York, United States, 13760
GSK Investigational Site
Manhasset, New York, United States, 11030
GSK Investigational Site
Manlius, New York, United States, 13104
GSK Investigational Site
New York, New York, United States, 10022
United States, North Dakota
GSK Investigational Site
Fargo, North Dakota, United States, 58122
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44195
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
GSK Investigational Site
Tulsa, Oklahoma, United States, 74136
United States, Oregon
GSK Investigational Site
Eugene, Oregon, United States, 97401
GSK Investigational Site
Medford, Oregon, United States, 97504-8456
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107-2568
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
United States, South Carolina
GSK Investigational Site
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
GSK Investigational Site
Germantown, Tennessee, United States, 38138
GSK Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78705
GSK Investigational Site
Georgetown, Texas, United States, 78626
GSK Investigational Site
Houston, Texas, United States, 77004
GSK Investigational Site
Houston, Texas, United States, 77030
GSK Investigational Site
San Antonio, Texas, United States, 78229
GSK Investigational Site
San Antonio, Texas, United States, 78258
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84107
United States, Vermont
GSK Investigational Site
Burlington, Vermont, United States, 05405
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98122
Sponsors and Collaborators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Publications of Results:
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Responsible Party: GlaxoSmithKline Identifier: NCT00240630     History of Changes
Other Study ID Numbers: TRX103632
First Posted: October 18, 2005    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: April 2015
Keywords provided by GlaxoSmithKline:
acute migraine
consistency of response
early intervention
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents