The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of two different drugs in the treatment of patients diagnosed with moderate to severe back pain.
* double-blind, double-dummy, non-inferiority, prospective, parallel group, intent to treat trial. * Experiment duration: 04 days. * 03 visits (days 0, 2 and 4). * Efficacy will be evaluated for back pain relief based on visual analog scale. * Adverse events evaluation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
83
Every 8 hours for 4 days.
Every 8 hours for 4 days.
IOT - Instituto de Ortopedia e Traumatologia
São Paulo, São Paulo, Brazil
Efficacy of treatment in back pain relief based on Visual Analog Scale (VAS).
The individual response rate to the relieve of pain is calculated by measuring VAS during the first and last visit. The response rate is calculated using the following formula: Response rate = (VASvi - VASvf) / VASvi Considering: * VASvi: VAS in the first visit; * VASvf: VAS at the last visit;
Time frame: 4 days
Safety will be evaluated by the adverse events occurrences
Adverse events will be collected and followed in order to evaluate safety and tolerability
Time frame: day 4
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