Acute Lumbago
Conditions
Brief 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.
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
Interventions
DRUGmeloxicam/cyclobenzaprine hydrochloride
two oral capsules a day during approximately 07 days
DRUGmeloxicam - Movatec®
two oral tablet a day during approximately 07 days
DRUGcyclobenzaprine - Miosan®
two oral tablet a day during approximately 07 days
Sponsors
Eurofarma Laboratorios S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Sign, initial and date the Informed Consent Form (ICF); * 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 triptans; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Reduction | Pain reduction 3 days after the administration of study drugs | Compare the treatment groups for the efficacy in pain reduction, 3 days after the administration of study drugs, when compared to the baseline assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of rescue medication use | During study treatment, an expected average of 7days | Assessment of frequency of rescue medication use, as well as the proportion of patients during study treatment; |
Countries
Brazil
Outcome results
None listed