Study Of Trexima In The Acute Treatment Of Multiple Migraine Attacks - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00240617

Purpose

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.

Condition	Intervention	Phase
Migraine	Drug: sumatriptan succinate/naproxen sodium	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Naproxen Naproxen sodium Succinic acid Sumatriptan Sumatriptan succinate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Score on a migraine pain scale at 2 hours through 24 hours for multiple migraine attacks [ Time Frame: on going ]

Secondary Outcome Measures:

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: on going ]

Enrollment:	623
Study Start Date:	October 2005
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
arm 1: Active Comparator	Drug: sumatriptan succinate/naproxen sodium comparator

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240617

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Locations

United States, Alabama
GSK Investigational Site
Tuscaloosa, Alabama, United States, 35406
GSK Investigational Site
Anniston, Alabama, United States, 36207
United States, Arizona
GSK Investigational Site
Phoenix, Arizona, United States, 85032
GSK Investigational Site
Mesa, Arizona, United States, 85201
United States, Arkansas
GSK Investigational Site
Hot Springs, Arkansas, United States, 71913
United States, California
GSK Investigational Site
San Diego, California, United States, 92128
GSK Investigational Site
San Diego, California, United States, 92108
GSK Investigational Site
Oceanside, California, United States, 92056
United States, Colorado
GSK Investigational Site
Boulder, Colorado, United States, 80304
United States, Florida
GSK Investigational Site
Stuart, Florida, United States, 34996
GSK Investigational Site
Miami, Florida, United States, 33173
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
GSK Investigational Site
South Daytona, Florida, United States, 32119
United States, Georgia
GSK Investigational Site
Rome, Georgia, United States, 30165
GSK Investigational Site
Decatur, Georgia, United States, 30033
GSK Investigational Site
Atlanta, Georgia, United States, 30342
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60607
United States, Indiana
GSK Investigational Site
Evansville, Indiana, United States, 47712
United States, Louisiana
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70808
United States, Michigan
GSK Investigational Site
Ann Arbor, Michigan, United States, 48104
United States, Minnesota
GSK Investigational Site
St. Louis Park, Minnesota, United States, 55426
United States, Missouri
GSK Investigational Site
St. Louis, Missouri, United States, 63141
United States, New Jersey
GSK Investigational Site
Moorestown, New Jersey, United States, 08057
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
United States, New York
GSK Investigational Site
New York, New York, United States, 10021
GSK Investigational Site
Valley Stream, New York, United States, 11580
GSK Investigational Site
Rochester, New York, United States, 14609
GSK Investigational Site
Albany, New York, United States, 12206
GSK Investigational Site
Bronx, New York, United States, 10467
GSK Investigational Site
Plainview, New York, United States, 11803
United States, North Carolina
GSK Investigational Site
Greensboro, North Carolina, United States, 27401
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
United States, Ohio
GSK Investigational Site
West Chester, Ohio, United States, 45069
GSK Investigational Site
Concinnati, Ohio, United States, 45219
GSK Investigational Site
Westerville, Ohio, United States, 43081
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
GSK Investigational Site
Eugene, Oregon, United States, 97401
GSK Investigational Site
Salem, Oregon, United States, 97301
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19114
United States, South Carolina
GSK Investigational Site
Anderson, South Carolina, United States, 29621
United States, Tennessee
GSK Investigational Site
Memphis, Tennessee, United States, 38105
GSK Investigational Site
Bristol, Tennessee, United States, 37620
GSK Investigational Site
Clarksville, Tennessee, United States, 37043
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229
GSK Investigational Site
Fort Worth, Texas, United States, 76135
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98195
GSK Investigational Site
Tacoma, Washington, United States, 98405
GSK Investigational Site
Wenatchee, Washington, United States, 98801

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	TRX103635
Study First Received:	October 14, 2005
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00240617 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

migraine
consistency of response
early intervention
satisfaction

Additional relevant MeSH terms:

Serotonin Agonists
Anti-Inflammatory Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Headache Disorders, Primary
Brain Diseases
Gout Suppressants
Headache Disorders
Sensory System Agents
Migraine Disorders
Therapeutic Uses
Vasoconstrictor Agents
Anti-Inflammatory Agents, Non-Steroidal

Analgesics
Naproxen
Nervous System Diseases
Cyclooxygenase Inhibitors
Central Nervous System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions
Sumatriptan
Serotonin Agents
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009