Study Comparing A New Drug Containing The Combination Meloxicam And Cyclobenzaprine In The Treatment Of Acute Lumbago

Summary

The purpose of this study is to assess the efficacy end tolerability of a new drug containing the combination meloxicam and cyclobenzaprine (7,5/10mg) and the same components alone in the treatment of acute lumbago.

Conditions

• Acute Lumbago

Interventions

DRUG

meloxicam/cyclobenzaprine hydrochloride

two oral capsules a day during approximately 07 days

DRUG

meloxicam - Movatec®

two oral tablet a day during approximately 07 days

DRUG

cyclobenzaprine - Miosan®

two oral tablet a day during approximately 07 days

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.

  lead INDUSTRY

Principal Investigators

• Alceu Chueiri · Hospital de Base de São José do Rio Preto

• Paulo Guilherme · Hospital Santa Marcelina

• Wagner Caiafa · Santa Casa de Juiz de Fora

• Antonio Scotton · Centro MIneiro de Pesquisa - Juiz de Fora

• Lindomar G. Oliveira · Clínica de Ortopedia e Fraturas de Goiania

• Antonio Carlos Ximenes · CIP Pesquisas Médicas Ltda

• Sonia Alvarenga · Faculdade de Medicina ABC

• Gilberto Brandão · Clínica Perdizes

• Luciana Teixeira · IMA Brasil - Instituto de Medicina Avançada

• Antonio Tarcísio · Santa Casa de Misericórdia de Belo Horizonte

• Carlos Roberto Galia · Hospital de Clínicas de Porto Alegre

• Mauro Hernandes · Santa Casa de Votuporanga

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-05-31

Primary Completion

2013-05-31

Completion

2013-05-31

Countries

• Brazil

Study Locations