Menstrual Migraine Treatment With TREXIMA - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00329355

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: NCT00329355

Hide Study Locations

Locations

United States, Arizona
GSK Investigational Site
Chandler, Arizona, United States, 85224
United States, California
GSK Investigational Site
San Francisco, California, United States, 94109
GSK Investigational Site
Santa Monica, California, United States, 90404
GSK Investigational Site
Irvine, California, United States, 92618
GSK Investigational Site
Redondo Beach, California, United States, 90277
United States, Colorado
GSK Investigational Site
Boulder, Colorado, United States, 80304
GSK Investigational Site
Colorado Springs, Colorado, United States, 80909
United States, Florida
GSK Investigational Site
Sunrise, Florida, United States, 33351
GSK Investigational Site
Port Orange, Florida, United States, 32127
GSK Investigational Site
West Palm Beach, Florida, United States, 33407
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60614
United States, Indiana
GSK Investigational Site
South Bend, Indiana, United States, 46601
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, Nebraska
GSK Investigational Site
Omaha, Nebraska, United States, 68134
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
New York, New York, United States, 10022
United States, North Carolina
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
GSK Investigational Site
Cincinnati, Ohio, United States, 45245
GSK Investigational Site
Cincinnati, Ohio, United States, 45267
GSK Investigational Site
Toledo, Ohio, United States, 43614-5809
GSK Investigational Site
West Chester, Ohio, United States, 45069
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19114
GSK Investigational Site
Carnegie, Pennsylvania, United States, 15106
United States, Rhode Island
GSK Investigational Site
Warwick, Rhode Island, United States, 02886
United States, South Carolina
GSK Investigational Site
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
GSK Investigational Site
Georgetown, Texas, United States, 78626
GSK Investigational Site
San Antonio, Texas, United States, 78229
GSK Investigational Site
Houston, Texas, United States, 77054
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98195

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:	TRX105852
Study First Received:	May 22, 2006
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00329355 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
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