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The purpose of this study is to evaluate the safety and efficacy of an association with one anti-inflammatory and one muscle relaxant agent compared to the one muscle relaxant agent isolated in the treatment of osteomuscular pain in adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMS association | Experimental | The patient will take 2 tablets (Combination of ketoprofen and cyclobenzaprine), oral, per day, each 12h. |
|
| MiosanĀ® | Active Comparator | The patient will take 2 tablets (cyclobenzaprine isolated), oral, per day, each 12h. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketoprofen and cyclobenzaprine association | Drug | The patient will take 2 tablets (Combination of ketoprofen and cyclobenzaprine), oral, per day, each 12h. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of osteomuscular treatment based on proportion of participants who achieve the 2, 3 or 4 points in the pain scale. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety will be evaluated by the adverse events occurrences | Maximal experiment duration: 9 days |
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IInclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allegisa | Campinas | SĆ£o Paulo | 13.084-791 | Brazil |
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| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D007660 | Ketoprofen |
| C004704 | cyclobenzaprine |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Cyclobenzaprine | Drug | The patient will take 2 tablets (cyclobenzaprine), oral, per day, each 12h. |
|
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |