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

Sponsored by:	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

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Dietary Sodium Headache Menstruation Migraine

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

U.S. FDA Resources

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

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

Show 34 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	TRX105850
Study First Received:	May 22, 2006
Last Updated:	November 19, 2008
ClinicalTrials.gov Identifier:	NCT00329459
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

menstrual migraine
dysmenorrhea
headache
early intervention

Study placed in the following topic categories:

Sumatriptan
Naproxen
Dysmenorrhea
Migraine Disorders
Headache

Central Nervous System Diseases
Headache Disorders, Primary
Brain Diseases
Serotonin
Headache Disorders

Additional relevant MeSH terms:

Serotonin Agonists
Anti-Inflammatory Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Cardiovascular Agents
Gout Suppressants
Pharmacologic Actions

Serotonin Agents
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009