drugset / Trial / NCT00434083

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

NCT00434083

Phase 3 Completed 1200 enrolled POZEN
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2004-07
Primary completion
Completion
2005-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Naproxen Small molecule 500 mg
Subject Sumatriptan Unknown 85 mg

Indications