NCT01390324

Efficacy and Safety of a Fixed-dose Combination of Naratriptan and Naproxen in Acute Treatment of Migraine

A Multicenter, National, Double-blind, Randomized Study to Evaluate the Efficacy and Safety of a Fixed-dose Combination of Naratriptan 2,5 mg + Naproxen 500 mg Relative to Efficacy and Safety of Each Monotherapy for the Acute Treatment of Migraine

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ache Laboratorios Farmaceuticos S.A. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether a fixed-dose combination of naratriptan + naproxen is effective compared each monotherapy for the acute treatment of migraine.

Conditions

• Migraine
• Headache

Interventions

Type	Name	Description
DRUG	Fixed-dose combination of naratriptan+naproxen	Tablets containing naratriptan 2,5 mg + naproxen 500 mg
DRUG	Naratriptan	Tablets containing naratriptan 2,5 mg
DRUG	Naproxen	Tablets containing naproxen 500 mg

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-07-11
• Last updated: 2016-10-19