Clinical Trials Directory

Trials / Completed

CompletedNCT00488514

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

Study TXA107977, a Long-Term Safety Study of a Combination Product Containing Sumatriptan Succinate and Naproxen Sodium for the Treatment of Migraine in Adolescents

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
656 (actual)
Sponsor
GlaxoSmithKline · Industry
Sex
All
Age
12 Years – 17 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen sodium) in adolescents (aged 12 to 17 years) for the acute treatment of migraine.

Conditions

Interventions

TypeNameDescription
DRUGCombination Tablet of Treximet (sumatriptan/naproxen sodium)Combination Tablet of Treximet(sumatriptan/naproxen sodium)

Timeline

Start date
2007-07-13
Primary completion
2009-08-01
Completion
2009-08-20
First posted
2007-06-20
Last updated
2017-05-18
Results posted
2010-09-06

Locations

77 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00488514. Inclusion in this directory is not an endorsement.