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

October 20, 2016 updated by: GlaxoSmithKline

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

This study was designed to determine efficacy of TREXIMA compared to placebo for the treatment of a menstrual migraine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

320

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
    • Arizona
      • Mesa, Arizona, United States, 85201
        • GSK Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • GSK Investigational Site
    • California
      • 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
        • GSK Investigational Site
    • Connecticut
      • Stamford, Connecticut, United States, 06902
        • GSK Investigational Site
    • Florida
      • Fort Lauderdale, Florida, United States, 33328
        • GSK Investigational Site
      • Miami, Florida, United States, 33173
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • GSK Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67207
        • GSK Investigational Site
    • Massachusetts
      • Milford, Massachusetts, United States, 01757
        • GSK Investigational Site
      • North Dartmouth, Massachusetts, United States, 02747
        • GSK Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • GSK Investigational Site
    • Missouri
      • Springfield, Missouri, United States, 65804
        • GSK Investigational Site
      • 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, 87102
        • GSK Investigational Site
    • New York
      • Albany, New York, United States, 12206
        • GSK Investigational Site
      • Plainview, New York, United States, 11803
        • GSK Investigational Site
      • Rochester, New York, United States, 14609
        • GSK Investigational Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • GSK Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • GSK Investigational Site
      • Independence, Ohio, United States, 44131
        • GSK Investigational Site
      • Westerville, Ohio, United States, 43081
        • GSK Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • GSK Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15236
        • GSK Investigational Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • GSK Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38018
        • GSK Investigational Site
    • Texas
      • Austin, Texas, United States, 78705
        • GSK Investigational Site
      • Fort Worth, Texas, United States, 76104
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84121
        • GSK Investigational Site
    • Washington
      • 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

Female

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: arm 2
placebo to match
Drug: placebo
placebo to match
Experimental: arm 1
Treximet (sumatriptan/naproxen sodium)
Drug: sumatriptan succinate/naproxen sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Score on a 4-point migraine pain scale for a single menstrual migraine attack
Time Frame: 2 to 48 hours
2 to 48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
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
from 2 to 48 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

May 1, 2006

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

May 22, 2006

First Submitted That Met QC Criteria

May 22, 2006

First Posted (Estimate)

May 24, 2006

Study Record Updates

Last Update Posted (Estimate)

October 24, 2016

Last Update Submitted That Met QC Criteria

October 20, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRX105850

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. Clinical Study Report
    Information identifier: TRX105850
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Annotated Case Report Form
    Information identifier: TRX105850
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Informed Consent Form
    Information identifier: TRX105850
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistical Analysis Plan
    Information identifier: TRX105850
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Dataset Specification
    Information identifier: TRX105850
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Study Protocol
    Information identifier: TRX105850
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Individual Participant Data Set
    Information identifier: TRX105850
    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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