Study Comparing A New Drug Containing The Combination Meloxicam And Cyclobenzaprine In The Treatment Of Acute Lumbago
NCT ID: NCT01587508
Last Updated: 2016-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2013-05-31
2013-05-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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meloxicam - Movatec®
meloxicam - Movatec®
two oral tablet a day during approximately 07 days
cyclobenzaprine - Miosan®,
cyclobenzaprine - Miosan®
two oral tablet a day during approximately 07 days
meloxicam/cyclobenzaprine hydrochloride
meloxicam/cyclobenzaprine hydrochloride
two oral capsules a day during approximately 07 days
Interventions
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meloxicam/cyclobenzaprine hydrochloride
two oral capsules a day during approximately 07 days
meloxicam - Movatec®
two oral tablet a day during approximately 07 days
cyclobenzaprine - Miosan®
two oral tablet a day during approximately 07 days
Eligibility Criteria
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Inclusion Criteria
* Be between 18 and 75 years old;
* Have acute lumbago with onset in less than 72 hours;
* Have a normal X-ray;
* Have a baseline score in the VAS higher than or equal to 40 mm;
Exclusion Criteria
* Use of monoamine oxidase inhibitors;
* Use of NSAIDs within the last week;
* Previous use of narcotics;
* Have any rheumatologic disease;
* Conditions of chronic pain;
* Have any significant chronic comorbidity;
* Previous history of gastrointestinal bleed or ulcers;
* History of allergy to any of the components of study medications;
* Recent history of a myocardial infarction, cardiac arrhythmia, cardiac conduction block or change, or congestive heart failure;
* Female patients who are pregnant or breastfeeding or who wish to become pregnant or who deny using safe contraceptive methods during the study will not be enrolled in the study;
* Have participated in another clinical trial within the last 12 months.
18 Years
75 Years
ALL
No
Sponsors
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Eurofarma Laboratorios S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Alceu Chueiri
Role: PRINCIPAL_INVESTIGATOR
Hospital de Base de São José do Rio Preto
Paulo Guilherme
Role: PRINCIPAL_INVESTIGATOR
Hospital Santa Marcelina
Wagner Caiafa
Role: PRINCIPAL_INVESTIGATOR
Santa Casa de Juiz de Fora
Antonio Scotton
Role: PRINCIPAL_INVESTIGATOR
Centro MIneiro de Pesquisa - Juiz de Fora
Lindomar G. Oliveira
Role: PRINCIPAL_INVESTIGATOR
Clínica de Ortopedia e Fraturas de Goiania
Antonio Carlos Ximenes
Role: PRINCIPAL_INVESTIGATOR
CIP Pesquisas Médicas Ltda
Sonia Alvarenga
Role: PRINCIPAL_INVESTIGATOR
Faculdade de Medicina ABC
Gilberto Brandão
Role: PRINCIPAL_INVESTIGATOR
Clínica Perdizes
Luciana Teixeira
Role: PRINCIPAL_INVESTIGATOR
IMA Brasil - Instituto de Medicina Avançada
Antonio Tarcísio
Role: PRINCIPAL_INVESTIGATOR
Santa Casa de Misericórdia de Belo Horizonte
Carlos Roberto Galia
Role: PRINCIPAL_INVESTIGATOR
Hospital de Clínicas de Porto Alegre
Mauro Hernandes
Role: PRINCIPAL_INVESTIGATOR
Santa Casa de Votuporanga
Locations
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CIP Pesquisas Médicas Ltda
Goiânia, Goiás, Brazil
Clínica de Ortopedia e Fraturas de Goiânia
Goiânia, Goiás, Brazil
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
Santa Casa de Juíz de Fora
Juiz de Fora, Minas Gerais, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Faculdade de Medicina ABC
Santo André, São Paulo, Brazil
Hospítal de Base
São José Rio Preto, São Paulo, Brazil
Clinica de Ortopedia e Fisiatria Perdizes
São Paulo, São Paulo, Brazil
Hospital Santa Marcelina
São Paulo, São Paulo, Brazil
IMA Brasil
São Paulo, São Paulo, Brazil
Santa Casa de Votuporanga
Votuporanga, São Paulo, Brazil
Countries
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Other Identifiers
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EF 127
Identifier Type: -
Identifier Source: org_study_id
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