TREXIMA For Menstrual Migraine in Women With Dysmenorrhea - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00329459

Purpose

This study was designed to determine efficacy of TREXIMA compared to placebo for the treatment of a menstrual migraine.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	See Detailed Description

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Menstruation 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 48 hours for a single menstrual migraine attack

Secondary Outcome Measures:

Freedom from all migraine pain and symptoms, satisfaction, presence or absence of neck pain/discomfort, sinus pain/pressure, menstrual symptoms, recurrence of head pain, safety and tolerability

Estimated Enrollment:	320
Study Start Date:	May 2006

Detailed Description:

A randomized, double-blind, single migraine attack, placebo-controlled, parallel group, multicenter study to evaluate the efficacy and tolerability of TREXIMA (sumatriptan succinate/naproxen sodium) tablets vs placebo when administered during the mild pain phase of menstrual migraine in women with dysmenorrhea

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
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: NCT00329459

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Locations

United States, Arizona
GSK Investigational Site
Mesa, Arizona, United States, 85201
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site
Newport Beach, California, United States, 92660
GSK Investigational Site
San Diego, California, United States, 92128
GSK Investigational Site
Fair Oaks, California, United States, 95628
GSK Investigational Site
San Francisco, California, United States, 94102
United States, Connecticut
GSK Investigational Site
Stamford, Connecticut, United States, 06902
United States, Florida
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33328
GSK Investigational Site
Miami, Florida, United States, 33173
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30342
United States, Kansas
GSK Investigational Site
Wichita, Kansas, United States, 67207
United States, Massachusetts
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
GSK Investigational Site
Milford, Massachusetts, United States, 01757
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48201
United States, Missouri
GSK Investigational Site
Springfield, Missouri, United States, 65804
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, 87102
United States, New York
GSK Investigational Site
Rochester, New York, United States, 14609
GSK Investigational Site
Plainview, New York, United States, 11803
GSK Investigational Site
Albany, New York, United States, 12206
United States, North Carolina
GSK Investigational Site
Greensboro, North Carolina, United States, 27401
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44195
GSK Investigational Site
Westerville, Ohio, United States, 43081
GSK Investigational Site
Independence, Ohio, United States, 44131
United States, Oregon
GSK Investigational Site
Eugene, Oregon, United States, 97401
United States, Pennsylvania
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
United States, South Carolina
GSK Investigational Site
Greer, South Carolina, United States, 29651
United States, Tennessee
GSK Investigational Site
Memphis, Tennessee, United States, 38018
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78705
GSK Investigational Site
Fort Worth, Texas, United States, 76104
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
United States, Washington
GSK Investigational Site
Wenatchee, Washington, United States, 98801

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	TRX105850
Study First Received:	May 22, 2006
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00329459 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

menstrual migraine
dysmenorrhea
headache
early intervention

Additional relevant MeSH terms:

Serotonin Agonists
Anti-Inflammatory Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Headache Disorders, Primary
Pain
Brain Diseases
Gout Suppressants
Headache Disorders
Signs and Symptoms
Pathologic Processes
Menstruation Disturbances
Dysmenorrhea
Migraine Disorders

Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Naproxen
Cyclooxygenase Inhibitors
Nervous System Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions
Sumatriptan
Serotonin Agents
Pelvic Pain

ClinicalTrials.gov processed this record on November 27, 2009