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

Sponsored by:	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:

Score on a migraine pain scale at 2 hours through 24 hours for a single probable migraine attack.

Secondary Outcome Measures:

Freedom from all migraine pain and symptoms, satisfaction, recurrence of head pain, safety and tolerability.

Estimated Enrollment:

20

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

Show 66 Study Locations

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
Last Updated:	August 20, 2008
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

Study placed in the following topic categories:

Serotonin Agonists
Anti-Inflammatory Agents
Neurotransmitter Agents
Naproxen
Cyclooxygenase Inhibitors
Central Nervous System Diseases
Headache Disorders, Primary
Cardiovascular Agents
Brain Diseases
Serotonin
Headache Disorders

Sumatriptan
Migraine Disorders
Analgesics, Non-Narcotic
Headache
Vasoconstrictor Agents
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Migraine without Aura

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 July 02, 2009