Study Of Treximet, Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks

October 24, 2016 updated by: GlaxoSmithKline

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 (*Treximet)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

623

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • GSK Investigational Site
      • Tuscaloosa, Alabama, United States, 35406
        • GSK Investigational Site
    • Arizona
      • Mesa, Arizona, United States, 85201
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85032
        • GSK Investigational Site
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • GSK Investigational Site
    • California
      • Irvine, California, United States, 92618
        • GSK Investigational Site
      • Oceanside, California, United States, 92056
        • GSK Investigational Site
      • San Diego, California, United States, 92128
        • GSK Investigational Site
      • San Diego, California, United States, 92108
        • GSK Investigational Site
    • Colorado
      • Boulder, Colorado, United States, 80304
        • GSK Investigational Site
    • Connecticut
      • Avon, Connecticut, United States, 06001
        • GSK Investigational Site
    • Florida
      • Miami, Florida, United States, 33173
        • GSK Investigational Site
      • Pembroke Pines, Florida, United States, 33024
        • GSK Investigational Site
      • South Daytona, Florida, United States, 32119
        • GSK Investigational Site
      • Stuart, Florida, United States, 34996
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • GSK Investigational Site
      • Decatur, Georgia, United States, 30033
        • GSK Investigational Site
      • Rome, Georgia, United States, 30165
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • GSK Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47712
        • GSK Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • GSK Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • GSK Investigational Site
    • Minnesota
      • St. Louis Park, Minnesota, United States, 55426
        • GSK Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • GSK Investigational Site
    • New Jersey
      • Moorestown, New Jersey, United States, 08057
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • GSK Investigational Site
    • New York
      • Albany, New York, United States, 12206
        • GSK Investigational Site
      • Bronx, New York, United States, 10467
        • GSK Investigational Site
      • New York, New York, United States, 10021
        • GSK Investigational Site
      • Plainview, New York, United States, 11803
        • GSK Investigational Site
      • Rochester, New York, United States, 14609
        • GSK Investigational Site
      • Valley Stream, New York, United States, 11580
        • GSK Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • GSK Investigational Site
      • Greensboro, North Carolina, United States, 27401
        • GSK Investigational Site
      • Raleigh, North Carolina, United States, 27609
        • GSK Investigational Site
    • Ohio
      • Concinnati, Ohio, United States, 45219
        • GSK Investigational Site
      • West Chester, Ohio, United States, 45069
        • GSK Investigational Site
      • Westerville, Ohio, United States, 43081
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • GSK Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • GSK Investigational Site
      • Salem, Oregon, United States, 97301
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
        • GSK Investigational Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • GSK Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • GSK Investigational Site
      • Clarksville, Tennessee, United States, 37043
        • GSK Investigational Site
      • Memphis, Tennessee, United States, 38105
        • GSK Investigational Site
    • Texas
      • Fort Worth, Texas, United States, 76135
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84121
        • GSK Investigational Site
    • Washington
      • Seattle, Washington, United States, 98195
        • GSK Investigational Site
      • Tacoma, Washington, United States, 98405
        • GSK Investigational Site
      • Wenatchee, Washington, United States, 98801
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: arm 1
Treximet (sumatriptan/naproxen sodium) formerly known as TREXIMA
Drug: sumatriptan succinate/naproxen sodium
comparator
Placebo Comparator: arm 2
placebo to match
Drug: placebo
placebo to match

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Score on a 4 pt migraine pain scale for multiple migraine attacks
Time Frame: 2 to 24 hours
2 to 24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2 to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

October 14, 2005

First Submitted That Met QC Criteria

October 14, 2005

First Posted (Estimate)

October 18, 2005

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRX103635

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: TRX103635
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Informed Consent Form
    Information identifier: TRX103635
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Clinical Study Report
    Information identifier: TRX103635
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Study Protocol
    Information identifier: TRX103635
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Annotated Case Report Form
    Information identifier: TRX103635
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistical Analysis Plan
    Information identifier: TRX103635
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Dataset Specification
    Information identifier: TRX103635
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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