Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA) - Full Text View

Purpose

This study was designed to determine efficacy of TREXIMET (sumatriptan/naproxen sodium), formerly known as TREXIMA compared to placebo for the treatment of a menstrual migraine.

Condition	Intervention	Phase
Migraine Disorders Migraine	Drug: sumatriptan succinate/naproxen sodium	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	See Detailed Description

Resource links provided by NLM:

MedlinePlus related topics: Headache Menstruation Migraine

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

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Score on a 4-pt migraine pain scale for a single menstrual migraine attack [ Time Frame: 2 to 48 hours ] [ Designated as safety issue: No ]

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 [ Time Frame: 2 to 48 hours ] [ Designated as safety issue: No ]


Enrollment:	320
Study Start Date:	May 2006

Intervention Details:

Other Name: sumatriptan succinate/naproxen sodium

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 (*TREXIMET)

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329355

Show 35 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Publications:

Mannix LK, Martin VT, Cady RK, Diamond ML, Lener SE, White JD, Derosier FJ, McDonald SA. Combination treatment for menstrual migraine and dysmenorrhea using sumatriptan-naproxen: two randomized controlled trials. Obstet Gynecol. 2009 Jul;114(1):106-13. doi: 10.1097/AOG.0b013e3181a98e4d.

Durham PL, Vause CV, Derosier F, McDonald S, Cady R, Martin V. Changes in salivary prostaglandin levels during menstrual migraine with associated dysmenorrhea. Headache. 2010 May;50(5):844-51. doi: 10.1111/j.1526-4610.2010.01657.x. Epub 2010 Mar 26.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Martin VT, Ballard J, Diamond MP, Mannix LK, Derosier FJ, Lener SE, Krishen A, McDonald SA. Relief of menstrual symptoms and migraine with a single-tablet formulation of sumatriptan and naproxen sodium. J Womens Health (Larchmt). 2014 May;23(5):389-96. doi: 10.1089/jwh.2013.4577. Epub 2014 Feb 28.

Cady RK, Diamond ML, Diamond MP, Ballard JE, Lener ME, Dorner DP, Derosier FJ, McDonald SA, White J, Runken MC. Sumatriptan-naproxen sodium for menstrual migraine and dysmenorrhea: satisfaction, productivity, and functional disability outcomes. Headache. 2011 May;51(5):664-73. doi: 10.1111/j.1526-4610.2011.01894.x.


Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00329355 History of Changes
Other Study ID Numbers:	TRX105852
Study First Received:	May 22, 2006
Last Updated:	November 15, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:


menstrual migraine headache dysmenorrhea early intervention

Additional relevant MeSH terms:


Migraine Disorders Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases Naproxen Sumatriptan Analgesics Analgesics, Non-Narcotic Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Antirheumatic Agents Cardiovascular Agents Central Nervous System Agents	Cyclooxygenase Inhibitors Enzyme Inhibitors Gout Suppressants Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Serotonin 5-HT1 Receptor Agonists Serotonin Agents Serotonin Receptor Agonists Therapeutic Uses Vasoconstrictor Agents

ClinicalTrials.gov processed this record on February 26, 2015