Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
TREXIMET® Versus Butalbital-containing Combination Medications for the Acute Treatment of Migraine in Adults
NCT00573170 · View on ClinicalTrials.gov ↗
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)
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00573170
The ClinicalTrials.gov registry entry for NCT00573170 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 375 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00573170 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Arizona, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00573170?
The interventions under investigation include: placebo (DRUG), TREXIMET® (DRUG), Butalbital-containing Combination Medications (BCM) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00573170?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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