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TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)

NCT ID: NCT00387881

Last Updated: 2016-12-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

679 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-02-29

Brief Summary

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This study was designed to determine the efficacy and tolerability of TREXIMET (formerly known as TREXIMA) compared to placebo for the acute treatment of probable migraine, a sub-type of migraine.

Detailed Description

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Conditions

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Migraine, Without Aura

Keywords

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sumatriptan succinate, naproxen sodium, parallel group, double-blind, placebo-controlled, Combination product, migrainous headache Probable migraine, a sub-type of Migraine probable migraine,

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to match Treximet tablets

Treximet

Group Type EXPERIMENTAL

sumatriptan succinate / naproxen sodium

Intervention Type DRUG

sumatriptan 85mg / naproxen sodium 500mg

Interventions

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sumatriptan succinate / naproxen sodium

sumatriptan 85mg / naproxen sodium 500mg

Intervention Type DRUG

Placebo

Placebo to match Treximet tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* At least a 6 month history of probably migraine (6 migraine attacks per month)
* Males and women of childbearing potential on a adequate contraception.

Exclusion Criteria

* Physician diagnosis of migraine; history of triptan or ergot use; history of headache prophylaxis use
* 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 the 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

Phoenix, Arizona, United States

Site Status

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Phoenix, Arizona, United States

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Anaheim, California, United States

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Buena Park, California, United States

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Diamond Bar, California, United States

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Newport Beach, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Santa Monica, California, United States

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Walnut Creek, California, United States

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Westlake Village, California, United States

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Colorado Springs, Colorado, United States

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Stamford, Connecticut, United States

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Miami, Florida, United States

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Pembroke Pines, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Evansville, Indiana, United States

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Wichita, Kansas, United States

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New Orleans, Louisiana, United States

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North Dartmouth, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Kalamazoo, Michigan, United States

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Saint Louis Park, Minnesota, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, 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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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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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Independence, Ohio, United States

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West Chester, Ohio, United States

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Westerville, Ohio, United States

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Medford, Oregon, United States

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Carnegie, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Anderson, South Carolina, United States

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Simpsonville, South Carolina, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Bellaire, Texas, United States

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Houston, Texas, United States

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Katy, Texas, United States

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Richardson, 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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Salt Lake City, Utah, United States

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Salt Lake City, Utah, United States

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West Jordan, Utah, United States

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Alexandria, Virginia, United States

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Seattle, Washington, United States

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Seattle, Washington, United States

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Wenatchee, Washington, United States

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Milwaukee, Wisconsin, United States

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Countries

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United States

References

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Silberstein S, Lipton RB, Goldstein J, Aurora SK, White J, Ochs-Ross R, Lener SE, McDonald SA. Evaluation of a New Fixed-dose Single Tablet of Sumatriptan Formulated with RT Technology and Naproxen Sodium (SumaRT/Nap) for the Acute Treatment of Probable Migraine without Aura. Headache 2008: presented at the American Headache Society Meeting, Boston, MA.

Reference Type RESULT

Study Documents

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Document Type: Study Protocol

View Document

Document Type: Dataset Specification

View Document

Document Type: Informed Consent Form

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Clinical Study Report

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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TXA107563

Identifier Type: -

Identifier Source: org_study_id