NCT01726920

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

A Phase III, Multicenter, National, Open, Randomized, Parallel and Comparative Study to Evaluate the Efficacy and Safety of a Fixed-dose Combination of Naratriptan 2,5 mg + Naproxen 500 mg 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• Status: Withdrawn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 2,5 mg + naproxen 500 mg is effective and safe compared each monotherapy for the acute treatment of migraine.

Conditions

• Migraine
• Headache

Interventions

Type	Name	Description
DRUG	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: 2014-07-01
• Primary completion: 2014-12-01
• First posted: 2012-11-15
• Last updated: 2016-03-16