Study Comparing A New Drug Containing The Combination Meloxicam And Cyclobenzaprine In The Treatment Of Acute Lumbago

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Acute Lumbago

Intervention / Treatment
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* Drug: meloxicam/cyclobenzaprine hydrochloride
* Drug: meloxicam - Movatec®
* Drug: cyclobenzaprine - Miosan®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: meloxicam - Movatec®<br> | Drug: meloxicam - Movatec®<br>* two oral tablet a day during approximately 07 days<br>|
| Active Comparator: cyclobenzaprine - Miosan®,<br> | Drug: cyclobenzaprine - Miosan®<br>* two oral tablet a day during approximately 07 days<br>|
| Experimental: meloxicam/cyclobenzaprine hydrochloride<br> | Drug: meloxicam/cyclobenzaprine hydrochloride<br>* two oral capsules a day during approximately 07 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Pain reduction 3 days after the administration of study drugs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of rescue medication use | Assessment of frequency of rescue medication use, as well as the proportion of patients during study treatment; | During study treatment, an expected average of 7days |