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

NCT ID: NCT00240617

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

623 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Migraine Disorders

Keywords

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consistency of response migraine satisfaction early intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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arm 1

Treximet (sumatriptan/naproxen sodium) formerly known as TREXIMA

Group Type ACTIVE_COMPARATOR

sumatriptan succinate/naproxen sodium

Intervention Type DRUG

comparator

arm 2

placebo to match

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo to match

Interventions

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sumatriptan succinate/naproxen sodium

comparator

Intervention Type DRUG

placebo

placebo to match

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Anniston, Alabama, United States

Site Status

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Tuscaloosa, Alabama, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Hot Springs, Arkansas, United States

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Irvine, California, United States

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Oceanside, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Boulder, Colorado, United States

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Avon, Connecticut, United States

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Miami, Florida, United States

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Pembroke Pines, Florida, United States

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South Daytona, Florida, United States

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Stuart, Florida, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Rome, Georgia, United States

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Chicago, Illinois, United States

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Evansville, Indiana, United States

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Baton Rouge, Louisiana, United States

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Ann Arbor, Michigan, United States

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Saint Louis Park, Minnesota, United States

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St Louis, Missouri, United States

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Moorestown, New Jersey, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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New York, New York, United States

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Plainview, New York, United States

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Rochester, New York, United States

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The Bronx, New York, United States

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Valley Stream, New York, United States

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Chapel Hill, North Carolina, United States

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Greensboro, North Carolina, United States

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Raleigh, North Carolina, United States

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Concinnati, Ohio, United States

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West Chester, Ohio, United States

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Westerville, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Salem, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Anderson, South Carolina, United States

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Bristol, Tennessee, United States

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Clarksville, Tennessee, United States

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Memphis, Tennessee, United States

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Fort Worth, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Seattle, Washington, United States

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Tacoma, Washington, United States

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GSK Investigational Site

Wenatchee, Washington, United States

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Countries

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United States

References

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Torgovnick J, Sethi NK, Arsura E. Consistency of response to sumatriptan/naproxen sodium in a placebo-controlled cross-over study. Cephalalgia. 2010 Oct;30(10):1277; author reply 1277-9. doi: 10.1177/0333102409352810. Epub 2010 May 13. No abstract available.

Reference Type RESULT
PMID: 20855373 (View on PubMed)

Study Documents

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Document Type: Individual Participant Data Set

View Document

Document Type: Informed Consent Form

View Document

Document Type: Clinical Study Report

View Document

Document Type: Study Protocol

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Dataset Specification

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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TRX103635

Identifier Type: -

Identifier Source: org_study_id