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COMPLETED
NCT04384367
PHASE3

Efficacy and Safety of Rizatriptan-Naproxen (10/550 mg) in the Acute Treatment of Migraine

Sponsor: Eurofarma Laboratorios S.A.

View on ClinicalTrials.gov

Summary

A phase III study, multicenter, double-blind, double-dummy, randomized, single-dose, placebo-controlled study to evaluate the efficacy and safety of Rizatriptan-Naproxen (10/550 mg) in the acute treatment of migraine. ⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

Official title: A Multicenter, Double-blind, Double-dummy, Randomized, Single-dose, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rizatriptan-Naproxen (10/550 mg) in the Acute Treatment of Migraine

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

2068

Start Date

2022-12-30

Completion Date

2024-11-30

Last Updated

2026-09-22

Healthy Volunteers

No

Conditions

Interventions

DRUG

Rizatriptan 10 mg + Naproxen 550mg

oral - single dose

DRUG

Maxalt 10Mg Tablet

oral - single dose

DRUG

Flanax 550mg

oral - single dose

DRUG

Placebo oral tablet

oral - single dose

Locations (2)

Eurofarma Laboratorios S.A

São Paulo, São Paulo, Brazil

CEPIC

São Paulo, São Paulo, Brazil