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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 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.

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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

Migraine Disorders

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

FieldValue
Enrollment Target 320 participants
Start Date 2006-05
Est. Completion 2006-11
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

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What the Registry Record Tells You About NCT00329459

The ClinicalTrials.gov registry entry for NCT00329459 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 300-participant average among 21 other Migraine Disorders trials with a reported enrollment target. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.