Study Comparing A New Drug Containing The Combination

Study Comparing A New Drug Containing The Combination
Meloxicam And Cyclobenzaprine In The Treatment Of Acute
Lumbago
Status: Withdrawn
Study Phase: Phase 3
Start Date: May 2013 | Completion Date: May 2013
Condition(s): Acute Lumbago
Full Title of Study
A Phase III, Randomized, Single-Blind, Superiority Study Comparing The Efficacy And
Tolerability Of A New Drug Containing The Combination Meloxicam And
Cyclobenzaprine And The Same Components Alone In The Treatment Of Acute
Lumbago
Overview
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.
Detailed Description
To assess the efficacy and tolerability of a new drug containing the combination
meloxicam and cyclobenzaprine in the treatment of acute lumbago, compared to the
same components alone. Some eligibility criteria: Have a normal X-ray of the lumbar
spine for the age; Have a baseline score in the VAS higher than or equal to 40 mm
Study Details
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study,
Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary
Purpose: Treatment
Investigator Details
Lead Sponsor: Eurofarma Laboratorios S.A.
Principal Investigator: Alceu Chueiri Hospital de Base de São José do Rio Preto
Principal Investigator: Paulo Guilherme Hospital Santa Marcelina
Principal Investigator: Wagner Caiafa Santa Casa de Juiz de Fora
Principal Investigator: Antonio Scotton Centro MIneiro de Pesquisa - Juiz de Fora
Principal Investigator: Lindomar G. Oliveira Clínica de Ortopedia e Fraturas de Goiania
Principal Investigator: Antonio Carlos Ximenes CIP Pesquisas Médicas Ltda
Principal Investigator: Sonia Alvarenga Faculdade de Medicina ABC
Principal Investigator: Gilberto Brandão Clínica Perdizes
Principal Investigator: Luciana Teixeira IMA Brasil - Instituto de Medicina Avançada
Principal Investigator: Antonio Tarcísio Santa Casa de Misericórdia de Belo Horizonte
Principal Investigator: Carlos Roberto Galia Hospital de Clínicas de Porto Alegre
Principal Investigator: Mauro Hernandes Santa Casa de Votuporanga
Trial Location Details
Facility: Clínica de Ortopedia e Fraturas de Goiânia Goiania, Brazil
Facility: CIP Pesquisas Médicas Ltda Goiânia -, Brazil
Facility: Santa Casa de Misericórdia de Belo Horizonte Belo Horizonte, Brazil
Facility: Santa Casa de Juíz de Fora Juiz de Fora, Brazil
Facility: Hospital de Clínicas de Porto Alegre Porto Alegre, Brazil
Facility: Faculdade de Medicina ABC Santo Andre,, Brazil
Facility: Clinica de Ortopedia e Fisiatria Perdizes São Paulo, Brazil
Facility: Hospital Santa Marcelina São Paulo, Brazil
Facility: IMA Brasil São Paulo, Brazil
Facility: Santa Casa de Votuporanga Votuporanga, Brazil
Facility: Hospítal de Base São José Rio Preto, Brazil
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
Information Source
ID Number: EF 127
NCT Identifier: NCT01587508
Health Authority: Array
Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT01587508
ClinicalTrials.gov processed this data on September 29, 2016
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