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NCT00573170 · ClinicalTrials.gov registry record · Phase 3
TREXIMET® Versus Butalbital-containing Combination Medications for the Acute Treatment of Migraine in Adults
A Phase 3 study of Migraine Disorders and Migraine, Acute, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 375
- Enrollment target
- 20
- Study locations
NCT00573170: Completed Phase 3 study of Migraine Disorders and Migraine, Acute, sponsored by GlaxoSmithKline.
NCT00573170 is a Phase 3 study of Migraine Disorders and Migraine, Acute that has completed, run by GlaxoSmithKline. The registered enrollment target is 375 participants, above the 297-participant average among 21 other Migraine Disorders trials with a reported enrollment target (26% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00573170, a Phase 3 study of Migraine Disorders and Migraine, Acute, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 375 participants
- Enrollment target
- 20
- Study locations
Study Summary
Study TRX109011/TRX109013, A Randomized, Double-blind, Double-dummy, Placebo-controlled, Crossover Study to Evaluate the Efficacy of TREXIMET® (Sumatriptan + Naproxen Sodium) versus Butalbital-containing Combination Medications (BCM) for the Acute Treatment of Migraine when administered during the Moderate-Severe Pain Phase of the Migraine (Studies 1 and 2 of 2)
Primary Outcome
SPF 2-24 hours is defined for all participants as having no pain at 2 hours post-dose and without the return of any pain or the use of any rescue medication (any medication taken after the first dose of study medication for any migraine pain or symptoms) from 2-24 hours.
Conditions Studied
Interventions
- DRUG placebo
- DRUG TREXIMET®
- DRUG Butalbital-containing Combination Medications (BCM)
Study Locations (20)
California
- GSK Investigational Site - Anaheim
- GSk Investigational Site - Anaheim
- GSK Investigational Site - Garden Grove
- GSK Investigational Site - Irvine
- GSK Investigational Site - Newport Beach
- GSK Investigational Site - Northridge
- GSK Investigational Site - Riverside
- GSK Investigational Site - Sacramento
- GSK Investigational Site - San Diego
- GSK Investigational Site - San Francisco
- GSK Investigational Site - Santa Monica
- GSK Investigational Site - Sherman Oaks
Arizona
- GSK Investigational Site - Chandler
- GSK Investigational Site - Gilbert
- GSK Investigational Site - Litchfield Park
- GSK Investigational Site - Mesa
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Tempe
Arkansas
- GSK Investigational Site - Little Rock
- GSK Investigational Site - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 375 participants |
| Start Date | 2008-02 |
| Est. Completion | 2009-08 |
| Phase | Phase 3 |
What the finished NCT00573170 record still lists
NCT00573170 is an interventional study that assigns participants to a tested intervention. The registered 375 participants enrollment target is mid-sized for trials with a published cap, above the 297-participant average among 21 other Migraine Disorders trials with a reported enrollment target (26% higher).
The record links to 2 conditions, with Migraine Disorders appearing as the primary indexed condition, and to 3 interventions - of which placebo is the first listed.
NCT00573170 names 20 study sites across 3 states, led by California, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT00573170 about?
NCT00573170 is a clinical study titled "TREXIMET® Versus Butalbital-containing Combination Medications for the Acute Treatment of Migraine in Adults". Study TRX109011/TRX109013, A Randomized, Double-blind, Double-dummy, Placebo-controlled, Crossover Study to Evaluate the Efficacy of TREXIMET® (Sumatriptan + Naproxen Sodium) versus Butalbital-containing Combination Medications (BCM) for the Acute Treatment of Migraine when administered during the M...
What is the current status of trial NCT00573170?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 375 participants. The study started on 2008-02. Estimated completion is 2009-08.
What conditions does trial NCT00573170 study?
This clinical trial studies the following conditions: Migraine Disorders, Migraine, Acute.
What interventions are being tested in trial NCT00573170?
The interventions under investigation include: placebo (DRUG), TREXIMET® (DRUG), Butalbital-containing Combination Medications (BCM) (DRUG).
Who is sponsoring clinical trial NCT00573170?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00573170 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Migraine Disorders
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00573170's enrollment target sits among peer trials
375 8th of 21 higher than 14 of 21 other Migraine Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Migraine Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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