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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 Oct 23, 2026, 3:57 PM 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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

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

Conditions and interventions

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
Sep 2006 (Type not available)
Primary completion
Feb 2008 (Actual)
Completion
Feb 2008 (Actual)
Last update posted
Dec 16, 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 16, 2016 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00387881 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →