NCT00434083

To Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migrane Headaches

A Double-Blind Multicenter, Randomized, Placebo-Controlled Single Dose Study to Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migrane Headaches

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,200 (planned)
• Sponsor: POZEN · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

* to demonstrate the superiority of Trexima (combination of sumatriptan as the succinate 85 mg and naproxen sodium 500 mg) versus placebo in the acute treatment of migraine * to demonstrate the superiority of Trexima versus the individual components (sumatriptan as the succinate 85 mg and naproxen sodium 500 mg), and * to evaluate the safety of the Trexima.

Conditions

• Migraine Headaches

Interventions

Type	Name	Description
DRUG	sumatriptan
DRUG	naproxen sodium

Timeline

• Start date: 2004-07-01
• Completion: 2005-01-01
• First posted: 2007-02-12
• Last updated: 2007-02-12

Locations

2 sites across 1 country: United States