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

Migraine Headaches Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00434083
Study type Interventional
Source POZEN
Contact
Status Completed
Phase Phase 3
Start date July 2004
Completion date January 2005
View Details
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