Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA)

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ClinicalTrials.gov Identifier: NCT00329355

Recruitment Status : Completed

First Posted : May 24, 2006

Last Update Posted : January 23, 2017

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Migraine Migraine Disorders	Drug: sumatriptan succinate/naproxen sodium	Phase 3

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)

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	351 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	May 2006
Actual Primary Completion Date :	November 2006
Actual Study Completion Date :	November 2006

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Migraine

MedlinePlus related topics: Menstruation Migraine

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

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Score on a 4-pt migraine pain scale for a single menstrual migraine attack [ Time Frame: 2 to 48 hours ]

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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00329355

Locations

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United States, Arizona
GSK Investigational Site
Chandler, Arizona, United States, 85224
United States, California
GSK Investigational Site
Irvine, California, United States, 92618
GSK Investigational Site
Redondo Beach, California, United States, 90277
GSK Investigational Site
San Francisco, California, United States, 94109
GSK Investigational Site
Santa Monica, California, United States, 90404
United States, Colorado
GSK Investigational Site
Boulder, Colorado, United States, 80304
GSK Investigational Site
Colorado Springs, Colorado, United States, 80909
United States, Florida
GSK Investigational Site
Port Orange, Florida, United States, 32127
GSK Investigational Site
Sunrise, Florida, United States, 33351
GSK Investigational Site
West Palm Beach, Florida, United States, 33407
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60614
United States, Indiana
GSK Investigational Site
South Bend, Indiana, United States, 46601
United States, Louisiana
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70808
United States, Michigan
GSK Investigational Site
Ann Arbor, Michigan, United States, 48104
United States, Nebraska
GSK Investigational Site
Omaha, Nebraska, United States, 68134
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
United States, New York
GSK Investigational Site
New York, New York, United States, 10021
GSK Investigational Site
New York, New York, United States, 10022
United States, North Carolina
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
GSK Investigational Site
Cincinnati, Ohio, United States, 45245
GSK Investigational Site
Cincinnati, Ohio, United States, 45267
GSK Investigational Site
Toledo, Ohio, United States, 43614-5809
GSK Investigational Site
West Chester, Ohio, United States, 45069
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
GSK Investigational Site
Carnegie, Pennsylvania, United States, 15106
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19114
United States, Rhode Island
GSK Investigational Site
Warwick, Rhode Island, United States, 02886
United States, South Carolina
GSK Investigational Site
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
GSK Investigational Site
Georgetown, Texas, United States, 78626
GSK Investigational Site
Houston, Texas, United States, 77054
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98195

Sponsors and Collaborators

GlaxoSmithKline

Investigators

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Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

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