Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00240630

Purpose

The purpose of this study is to determine the consistency of response for Treximet (sumatriptan/naproxen sodium), formerly known as Trexima, when treating four acute migraine attacks at the mild pain phase and within 1 hour of onset of head pain.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-blind, Multi-center, Placebo-controlled, Cross-over Study to Determine the Consistency of Response for Trexima (Sumatriptan 85mg/Naproxen Sodium 500mg) Administered During the Mild Pain Phase for the Acute Treatment of Multiple Migraine Attacks

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 for multiple migraine attacks [ Time Frame: 2 to 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Within patient consistency of response, freedom from all migraine pain and symptoms, satisfaction, presence or absence of neck pain/discomfort, sinus pain/pressure, recurrence of head pain, safety and tolerability [ Time Frame: 2 to 24 hours ] [ Designated as safety issue: No ]

Enrollment:	600
Study Start Date:	October 2005

Arms	Assigned Interventions
Placebo Comparator: Arm 1 placebo to match	Drug: sumatriptan succinate/naproxen sodium Combination Tablet of Treximet Other Name: sumatriptan succinate/naproxen sodium
Experimental: Arm 2 Treximet (sumatriptan/naproxen sodium)	Drug: placebo placebo to match

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 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: NCT00240630

Show 50 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Publications:

Torgovnick J, Sethi NK, Arsura E, Lipton RB, Dodick DW, Adelman JU, Lener SE, White JD, McDonald SA. Consistency of response to sumatriptan/naproxen sodium in a placebo-controlled cross-over study. Cephalalgia. 2010 Oct;30(10):1277-9. Epub 2010 May 13. No abstract available.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00240630 History of Changes
Other Study ID Numbers:	TRX103632
Study First Received:	October 14, 2005
Last Updated:	September 1, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

acute migraine
consistency of response
satisfaction
migraine
early intervention

Additional relevant MeSH terms:

Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Naproxen
Sumatriptan
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Vasoconstrictor Agents
Cardiovascular Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on February 09, 2012