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Long-Term Safety of Treximet (Sumatriptan/Naproxen Sodium) for Migraine in Adolescents

NCT00488514 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 656

Last updated 2017-05-18

Study results available
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Summary

This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen sodium) in adolescents for the acute treatment of migraine.

Conditions

  • Migraine Disorders

Interventions

DRUG

Combination Tablet of Treximet (sumatriptan/naproxen sodium)

Combination Tablet of Treximet(sumatriptan/naproxen sodium)

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-13
Primary Completion
2009-08-01
Completion
2009-08-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00488514 on ClinicalTrials.gov