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Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as TREXIMA, for Menstrual Migraine in Women With Dysmenorrhea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00329459
Recruitment Status : Completed
First Posted : May 24, 2006
Last Update Posted : October 24, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
This study was designed to determine efficacy of TREXIMA compared to placebo for the treatment of a menstrual migraine.

Condition or disease Intervention/treatment Phase
Migraine Disorders Drug: sumatriptan succinate/naproxen sodium Drug: placebo 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 was formerly known as TREXIMA)
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 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, Patallel-group Multicenter Study to Evaluate the Efficacy and Tolerability or 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

MedlinePlus Genetics related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: arm 1
Treximet (sumatriptan/naproxen sodium)
 Drug: sumatriptan succinate/naproxen sodium
Placebo Comparator: arm 2
placebo to match
 Drug: placebo
placebo to match


Outcome Measures
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Primary Outcome Measures :
  1. Score on a 4-point migraine pain scale for a single menstrual migraine attack [ Time Frame: 2 to 48 hours ]

Secondary Outcome Measures :
  1. 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: from 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
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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): NCT00329459


Locations
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United States, Arizona
GSK Investigational Site
Mesa, Arizona, United States, 85201
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site
Fair Oaks, California, United States, 95628
GSK Investigational Site
Newport Beach, California, United States, 92660
GSK Investigational Site
San Diego, California, United States, 92128
GSK Investigational Site
San Francisco, California, United States, 94102
United States, Connecticut
GSK Investigational Site
Stamford, Connecticut, United States, 06902
United States, Florida
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33328
GSK Investigational Site
Miami, Florida, United States, 33173
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30342
United States, Kansas
GSK Investigational Site
Wichita, Kansas, United States, 67207
United States, Massachusetts
GSK Investigational Site
Milford, Massachusetts, United States, 01757
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48201
United States, Missouri
GSK Investigational Site
Springfield, Missouri, United States, 65804
GSK Investigational Site
St. Louis, Missouri, United States, 63141
United States, New Jersey
GSK Investigational Site
Moorestown, New Jersey, United States, 08057
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87102
United States, New York
GSK Investigational Site
Albany, New York, United States, 12206
GSK Investigational Site
Plainview, New York, United States, 11803
GSK Investigational Site
Rochester, New York, United States, 14609
United States, North Carolina
GSK Investigational Site
Greensboro, North Carolina, United States, 27401
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44195
GSK Investigational Site
Independence, Ohio, United States, 44131
GSK Investigational Site
Westerville, Ohio, United States, 43081
United States, Oregon
GSK Investigational Site
Eugene, Oregon, United States, 97401
United States, Pennsylvania
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
United States, South Carolina
GSK Investigational Site
Greer, South Carolina, United States, 29651
United States, Tennessee
GSK Investigational Site
Memphis, Tennessee, United States, 38018
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78705
GSK Investigational Site
Fort Worth, Texas, United States, 76104
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
United States, Washington
GSK Investigational Site
Wenatchee, Washington, United States, 98801
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: TRX105850
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: TRX105850
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: TRX105850
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: TRX105850
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: TRX105850
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: TRX105850
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: TRX105850
For additional information about this study please refer to the GSK Clinical Study Register

Publications of Results:

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

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00329459    
Other Study ID Numbers: TRX105850
First Posted: May 24, 2006    Key Record Dates
Last Update Posted: October 24, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Keywords provided by GlaxoSmithKline:
menstrual migraine
headache
early intervention
dysmenorrhea
Additional relevant MeSH terms:
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Migraine Disorders
Dysmenorrhea
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Naproxen
Sumatriptan
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents