TREXIMA (Currently Treximet) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1) - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00387881

Purpose

This study was designed to determine the efficacy and tolerability of TREXIMA compared to placebo for the acute treatment of probable migraine, a sub-type of migraine.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Tolerability of TREXIMA(tm) (Sumatriptan Succinate/Naproxen Sodium) for a Single Moderate or Severe Headache in Adults Diagnosed With Probable Migraine Without Aura (ICHD-II 1.6.1)

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:

Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose. [ Time Frame: 2 hours through 24 hours after Treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment [ Time Frame: 0.5, 1, and 4 hours after Treatment ] [ Designated as safety issue: No ]
Sustained Headache Relief 2-24 Hours After Treatment [ Time Frame: 2-24 hours after treatment ] [ Designated as safety issue: No ]
Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment [ Time Frame: 0.5, 1, 2, and 4 hours after treatment ] [ Designated as safety issue: No ]
Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment [ Time Frame: 0 - 24 hours after treatment ] [ Designated as safety issue: No ]
Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment [ Time Frame: 1-2, and 2- 4 hours after treatment ] [ Designated as safety issue: No ]
Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours [ Time Frame: 1-2 and 2-4 hours after treatment ] [ Designated as safety issue: No ]
Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment [ Time Frame: 2 and 4 hours after treatment ] [ Designated as safety issue: No ]
Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score [ Time Frame: 0 - 24 hours after treatment ] [ Designated as safety issue: No ]

Enrollment:

679

Detailed Description:

Phase 3 Inverventional

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 probably migraine (6 migraine attacks per month)
Males and women of childbearing potential on a adequate contraception.

Exclusion Criteria:

Physician diagnosis of migraine; history of triptan or ergot use; history of headache prophylaxis use
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 the 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: NCT00387881

Hide Study Locations

Locations

United States, Arizona
HOPE Research Institute
Phoenix, Arizona, United States, 85050
Central Phoenix Medical Clinic
Phoenix, Arizona, United States, 85014
United States, Arkansas
Clinical Study Centers
Little Rock, Arkansas, United States, 72205
United States, California
NuLife Clinical Research, Inc.
Anaheim, California, United States, 92805
Clinical Neurology and Electromyography
Newport Beach, California, United States, 92660
San Francisco Clinical Research Center
San Francisco, California, United States, 94109
NuLife Clinical Research, Inc.
Anaheim, California, United States, 92805
Centre for Health Care
San Diego, California, United States, 92128
Westlake Medical Research
Westlake Village, California, United States, 91361
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
Neurological Research Institute of the East Bay
Walnut Creek, California, United States, 94596
Neurological Research Institute
Santa Monica, California, United States, 90404
United States, Colorado
Clinicos, Llc
Colorado Springs, Colorado, United States, 80904
United States, Connecticut
The New England Center for Headaches, PC
Stamford, Connecticut, United States, 06902
United States, Florida
University Clinical Research, Inc.
Pembroke Pines, Florida, United States, 33024
Research Consultants Group
Miami, Florida, United States, 33144
United States, Georgia
Neurology & Headache Specitalists of Atlanta, LCC
Decatur, Georgia, United States, 30033
Georgia Clinical Research
Atlanta, Georgia, United States, 30308
Neurology & Headache Specitalists of Atlanta, LCC
Decatur, Georgia, United States, 30033
United States, Illinois
Diamond Headache Clinic
Chicago, Illinois, United States, 60614
United States, Indiana
Oliver Headache and Pain Clinic
Evansville, Indiana, United States, 47712
United States, Kansas
Heartland Research
Wichita, Kansas, United States, 67207
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Northeast Medical Research Associates
North Dartmouth, Massachusetts, United States, 02747
United States, Michigan
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, United States, 48104
United States, Minnesota
Park Nicollet Health Services
Minneapolis, Minnesota, United States, 55426
United States, Missouri
Mercy Health Research
St. Louis, Missouri, United States, 63141
Headache Care Center, Clinvest, Inc.
Springfield, Missouri, United States, 65807
United States, Nevada
Radiant Research
Las Vegas, Nevada, United States, 89146
United States, New Mexico
Lovelace Scientific Research
Albuquerque, New Mexico, United States, 87108
United States, New York
Braveman-Panza Medical Group
Albany, New York, United States, 12206
North Shore Pain Services, LLP
Valley Stream, New York, United States, 11580
University of Rochester
Rochester, New York, United States, 14642
Montefiore Memorial Hospital
Bronx, New York, United States, 10461
Analgesic Development Ltd.
New York, New York, United States, 10022
United States, North Carolina
UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Headache Wellness Center
Greensboro, North Carolina, United States, 27401
Triangle Medical Research Associates
Raleigh, North Carolina, United States, 27609
UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
ClinExcel Research
West Chester, Ohio, United States, 45069
New Albany Surgical Hospital Foundation
Westerville, Ohio, United States, 43081
The Cleveland Clinic Founcation
Cleveland, Ohio, United States, 44195
Community Research
Cincinnati, Ohio, United States, 45245
Community Research
Cincinnati, Ohio, United States, 45245
United States, Oregon
Medford Neurological & Spine Clinic
Medford, Oregon, United States, 97504
United States, Pennsylvania
Preferred Primary Care Physicians
Pittsburg, Pennsylvania, United States, 15236
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Radiant Research
Anderson, South Carolina, United States, 29621
Hillcrest Clinical Research, LLC
Simpsonville, South Carolina, United States, 29681
United States, Tennessee
Nashville Neuroscience Group
Nashville, Tennessee, United States, 37203
United States, Texas
Benchmark Research
Austin, Texas, United States, 78705
Neuro
Houston, Texas, United States, 77030
Bellaire Neurology
Bellaire, Texas, United States, 77401
Clinical Researchers of South Texas
Katy, Texas, United States, 77450
Innovative Clinical Trials
San Antonio, Texas, United States, 78229
Primary Care
Austin, Texas, United States, 78745
United States, Utah
Foothill Family Clinicl South
Salt Lake City, Utah, United States, 84121
Holladay Family Practice
Salt Lake City, Utah, United States, 84107
Foothill Family Clinic
Salt Lake City, Utah, United States, 84109
Southwest Family Medicine
West Jordan, Utah, United States, 84084
Holladay Family Practice
Salt Lake, Utah, United States, 84107
United States, Virginia
Alexandria Fairfax Neurology, PC
Alexandria, Virginia, United States, 22311
United States, Washington
Swedsih Medical Center
Seattle, Washington, United States, 98104
Wentachee Valley Medical Center
Wenatchee, Washington, United States, 98801
University of Washington Medical Center
Seattle, Washington, United States, 98105

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Study ID Numbers:	TXA107563
Study First Received:	October 11, 2006
Results First Received:	February 19, 2009
Last Updated:	November 11, 2009
ClinicalTrials.gov Identifier:	NCT00387881 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Combination product,
sumatriptan succinate,
naproxen sodium,
double-blind,
placebo-controlled,

parallel group,
probable migraine,
migrainous headache
Probable migraine, a sub-type of Migraine

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