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NCT00329459 · ClinicalTrials.gov registry record · Phase 3
Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as TREXIMA, for Menstrual Migraine in Women With Dysmenorrhea
A Phase 3 study of Migraine Disorders, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 320
- Enrollment target
- 20
- Study locations
NCT00329459: Completed Phase 3 study of Migraine Disorders, sponsored by GlaxoSmithKline.
NCT00329459 is a Phase 3 study of Migraine Disorders that has completed, run by GlaxoSmithKline. The registered enrollment target is 320 participants, roughly in line with the 300-participant average among 21 other Migraine Disorders trials with a reported enrollment target. The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00329459, a Phase 3 study of Migraine Disorders, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 320 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study was designed to determine efficacy of TREXIMA compared to placebo for the treatment of a menstrual migraine.
Conditions Studied
Interventions
- DRUG placebo
- DRUG sumatriptan succinate/naproxen sodium
Study Locations (20)
California
- GSK Investigational Site - Fair Oaks
- GSK Investigational Site - Newport Beach
- GSK Investigational Site - San Diego
- GSK Investigational Site - San Francisco
Florida
- GSK Investigational Site - Fort Lauderdale
- GSK Investigational Site - Miami
Massachusetts
- GSK Investigational Site - Milford
- GSK Investigational Site - North Dartmouth
Missouri
- GSK Investigational Site - Springfield
- GSK Investigational Site - St Louis
New York
- GSK Investigational Site - Albany
- GSK Investigational Site - Plainview
Arizona
- GSK Investigational Site - Mesa
Arkansas
- GSK Investigational Site - Little Rock
Connecticut
- GSK Investigational Site - Stamford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2006-05 |
| Est. Completion | 2006-11 |
| Phase | Phase 3 |
What the finished NCT00329459 record still lists
NCT00329459 is an interventional study that assigns participants to a tested intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 300-participant average among 21 other Migraine Disorders trials with a reported enrollment target.
The record links to 1 condition, with Migraine Disorders appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00329459 names 20 study sites across 13 states, led by California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00329459 about?
NCT00329459 is a clinical study titled "Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as TREXIMA, for Menstrual Migraine in Women With Dysmenorrhea". This study was designed to determine efficacy of TREXIMA compared to placebo for the treatment of a menstrual migraine.
What is the current status of trial NCT00329459?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 320 participants. The study started on 2006-05. Estimated completion is 2006-11.
What conditions does trial NCT00329459 study?
This clinical trial studies the following conditions: Migraine Disorders.
What interventions are being tested in trial NCT00329459?
The interventions under investigation include: placebo (DRUG), sumatriptan succinate/naproxen sodium (DRUG).
Who is sponsoring clinical trial NCT00329459?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00329459 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Connecticut, Florida. 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 NCT00329459's enrollment target sits among peer trials
320 9th of 21 higher than 13 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
COMPLETED · Phase 3
-
Long-Term Safety of Treximet (Sumatriptan/Naproxen Sodium) for Migraine in Adolescents
COMPLETED · Phase 3
-
Study Of Treximet, Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks
COMPLETED · Phase 3
-
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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