Acute Lumbago Clinical Trial
Official title:
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
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment