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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00387881

Public ClinicalTrials.gov record NCT00387881. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 4:58 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Tolerability of TREXIMA* (Sumatriptan Succinate/Naproxen Sodium) for a Single Moderate or Severe Headache in Adults Diagnosed With Probable Migraine Without Aura (ICHD-II 1.6.1) (*TREXIMET)

Study identification

NCT ID
NCT00387881
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
GlaxoSmithKline
Industry
Enrollment
679 participants

Conditions and interventions

Interventions

  • sumatriptan succinate / naproxen sodium Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 2006
Primary completion
Jan 31, 2008
Completion
Jan 31, 2008
Last update posted
Dec 15, 2016

2006 – 2008

United States locations

U.S. sites
70
U.S. states
29
U.S. cities
61
Facility City State ZIP Site status
GSK Investigational Site Phoenix Arizona 85014
GSK Investigational Site Phoenix Arizona 85050
GSK Investigational Site Little Rock Arkansas 72205
GSK Investigational Site Anaheim California 92801
GSK Investigational Site Anaheim California 92805
GSK Investigational Site Buena Park California 90620
GSK Investigational Site Diamond Bar California 91765
GSK Investigational Site Newport Beach California 92660
GSK Investigational Site San Diego California 92128
GSK Investigational Site San Francisco California 94109
GSK Investigational Site Santa Monica California 90404
GSK Investigational Site Walnut Creek California 94596
GSK Investigational Site Westlake Village California 91361
GSK Investigational Site Colorado Springs Colorado 80904
GSK Investigational Site Stamford Connecticut 06902
GSK Investigational Site Miami Florida 331144
GSK Investigational Site Pembroke Pines Florida 33024
GSK Investigational Site West Palm Beach Florida 33407
GSK Investigational Site Atlanta Georgia 30033
GSK Investigational Site Atlanta Georgia 30308
GSK Investigational Site Atlanta Georgia 30342
GSK Investigational Site Chicago Illinois 60614
GSK Investigational Site Evansville Indiana 47712
GSK Investigational Site Wichita Kansas 67207
GSK Investigational Site New Orleans Louisiana 70121
GSK Investigational Site North Dartmouth Massachusetts 02747
GSK Investigational Site Ann Arbor Michigan 48104
GSK Investigational Site Kalamazoo Michigan 49009
GSK Investigational Site Saint Louis Park Minnesota 55426
GSK Investigational Site Springfield Missouri 65804
GSK Investigational Site St Louis Missouri 63141
GSK Investigational Site Las Vegas Nevada 89146
GSK Investigational Site Albuquerque New Mexico 87108
GSK Investigational Site Albany New York 12206
GSK Investigational Site New York New York 10022
GSK Investigational Site Rochester New York 14642
GSK Investigational Site The Bronx New York 10461
GSK Investigational Site Valley Stream New York 11580
GSK Investigational Site Chapel Hill North Carolina 27599
GSK Investigational Site Greensboro North Carolina 27401
GSK Investigational Site Raleigh North Carolina 27609
GSK Investigational Site Cincinnati Ohio 45245
GSK Investigational Site Cleveland Ohio 44195
GSK Investigational Site Independence Ohio 44131
GSK Investigational Site West Chester Ohio 45069
GSK Investigational Site Westerville Ohio 43081
GSK Investigational Site Medford Oregon 97504-8456
GSK Investigational Site Carnegie Pennsylvania 15106
GSK Investigational Site Philadelphia Pennsylvania 19107-2568
GSK Investigational Site Pittsburgh Pennsylvania 15213
GSK Investigational Site Pittsburgh Pennsylvania 15236
GSK Investigational Site Anderson South Carolina 29621
GSK Investigational Site Simpsonville South Carolina 29681
GSK Investigational Site Nashville Tennessee 37203
GSK Investigational Site Austin Texas 78705
GSK Investigational Site Austin Texas 78745
GSK Investigational Site Bellaire Texas 77401
GSK Investigational Site Houston Texas 77030
GSK Investigational Site Katy Texas 77450
GSK Investigational Site Richardson Texas 75080
GSK Investigational Site San Antonio Texas 78229
GSK Investigational Site Salt Lake City Utah 84107
GSK Investigational Site Salt Lake City Utah 84109
GSK Investigational Site Salt Lake City Utah 84121
GSK Investigational Site West Jordan Utah 84084
GSK Investigational Site Alexandria Virginia 22311
GSK Investigational Site Seattle Washington 98104
GSK Investigational Site Seattle Washington 98195
GSK Investigational Site Wenatchee Washington 98801
GSK Investigational Site Milwaukee Wisconsin 53209-0996

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00387881, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 15, 2016 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00387881 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →