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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 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.

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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.

Conditions Studied

Migraine Disorders

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

FieldValue
Enrollment Target 656 participants
Start Date 2007-07-13
Est. Completion 2009-08-20
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

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What the Registry Record Tells You About NCT00488514

The ClinicalTrials.gov registry entry for NCT00488514 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 656 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 284-participant average among 21 other Migraine Disorders trials with a reported enrollment target (131% higher). 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 1 intervention - of which Combination Tablet of Treximet (sumatriptan/naproxen sodium) is the first listed.

NCT00488514 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.

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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.