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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
two oral capsules a day during approximately 07 days
two oral tablet a day during approximately 07 days
two oral tablet a day during approximately 07 days
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
Pain Reduction
Compare the treatment groups for the efficacy in pain reduction, 3 days after the administration of study drugs, when compared to the baseline assessment.
Time frame: Pain reduction 3 days after the administration of study drugs
Frequency of rescue medication use
Assessment of frequency of rescue medication use, as well as the proportion of patients during study treatment;
Time frame: During study treatment, an expected average of 7days
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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
...and 1 more locations