TREXIMA 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, Without Aura	Drug: sumatriptan succinate / naproxen sodium Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), 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
Study Start Date:	September 2006
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treximet: Experimental	Drug: sumatriptan succinate / naproxen sodium sumatriptan 85mg / naproxen sodium 500mg
Placebo: Placebo Comparator	Drug: Placebo Placebo to match Treximet tablets

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 67 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	TXA107563
Study First Received:	October 11, 2006
Results First Received:	February 19, 2009
Last Updated:	January 28, 2010
ClinicalTrials.gov Identifier:	NCT00387881 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

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 February 08, 2010