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NCT00488514 · ClinicalTrials.gov registry record · Phase 3
Long-Term Safety of Treximet (Sumatriptan/Naproxen Sodium) for Migraine in Adolescents
A Phase 3 study of Migraine Disorders, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 656
- Enrollment target
- 20
- Study locations
NCT00488514: Completed Phase 3 study of Migraine Disorders, sponsored by GlaxoSmithKline.
NCT00488514 is a Phase 3 study of Migraine Disorders that has completed, run by GlaxoSmithKline. The registered enrollment target is 656 participants, above the 284-participant average among 21 other Migraine Disorders trials with a reported enrollment target (131% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00488514, a Phase 3 study of Migraine Disorders, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 656 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen sodium) in adolescents for the acute treatment of migraine.
Primary Outcome
The number of participants with a drug-related adverse event (AE). Frequency threshold for reporting a drug-related AE: \>=2% participants recorded as having at least one occurrence of a reported drug-related AE.
Conditions Studied
Interventions
- DRUG Combination Tablet of Treximet (sumatriptan/naproxen sodium)
Study Locations (20)
California
- GSK Investigational Site - Chico
- GSK Investigational Site - Fair Oaks
- GSK Investigational Site - Fresno
- GSK Investigational Site - Fullerton
- GSK Investigational Site - Huntington Beach
- GSK Investigational Site - Irvine
- GSK Investigational Site - La Jolla
- GSK Investigational Site - Newport Beach
- GSK Investigational Site - Northridge
- GSK Investigational Site - Redondo Beach
- GSK Investigational Site - Roseville
- GSK Investigational Site - Sacramento
- GSK Investigational Site - San Francisco
- GSK Investigational Site - Santa Monica
- GSK Investigational Site - Walnut Creek
Arizona
- GSK Investigational Site - Gilbert
- GSK Investigational Site - Phoenix
Arkansas
- GSK Investigational Site - Jonesboro
- GSK Investigational Site - Little Rock
Colorado
- GSK Investigational Site - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 656 participants |
| Start Date | 2007-07-13 |
| Est. Completion | 2009-08-20 |
| Phase | Phase 3 |
What the finished NCT00488514 record still lists
NCT00488514 is an interventional study that assigns participants to a tested intervention. The registered 656 participants enrollment target is mid-sized for trials with a published cap, above the 284-participant average among 21 other Migraine Disorders trials with a reported enrollment target (131% higher).
The record links to 1 condition, with Migraine Disorders appearing as the primary indexed condition, and to 1 intervention - of which Combination Tablet of Treximet (sumatriptan/naproxen sodium) is the first listed.
NCT00488514 names 20 study sites across 4 states, led by California, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT00488514 about?
NCT00488514 is a clinical study titled "Long-Term Safety of Treximet (Sumatriptan/Naproxen Sodium) for Migraine in Adolescents". This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen sodium) in adolescents for the acute treatment of migraine.
What is the current status of trial NCT00488514?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 656 participants. The study started on 2007-07-13. Estimated completion is 2009-08-20.
What conditions does trial NCT00488514 study?
This clinical trial studies the following conditions: Migraine Disorders.
What interventions are being tested in trial NCT00488514?
The interventions under investigation include: Combination Tablet of Treximet (sumatriptan/naproxen sodium) (DRUG).
Who is sponsoring clinical trial NCT00488514?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00488514 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado. 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 NCT00488514's enrollment target sits among peer trials
656 3rd of 21 higher than 19 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
-
Phase 3 Study of MAP0004 in Adult Migraineurs
COMPLETED · Phase 3
-
A Multicenter Assessment of ALD403 in Frequent Episodic Migraine
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Study Of Treximet, Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks
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Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as TREXIMA, for Menstrual Migraine in Women With Dysmenorrhea
COMPLETED · Phase 3
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TREXIMET® Versus Butalbital-containing Combination Medications for the Acute Treatment of Migraine in Adults
COMPLETED · Phase 3
-
Migraine Manager (R01)
RECRUITING · Phase 2
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