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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 plus caffeine compared to one anti-inflammatory plus caffeine 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 and caffeine), oral, per day, each 12h. |
|
| Miosan Caf® | Active Comparator | The patient will take 2 tablets (combination of Cyclobenzaprine and caffeine), oral, per day, each 12h. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketoprofen and cyclobenzaprine association with caffeine | Drug | The patient will take 2 tablets (combination of ketoprofen and cyclobenzaprine and caffeine), 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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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associação dos funcionários públicos do estado do RGS | Porto Alegre | Rio Grande do Sul | Brazil | |||
| Centro de Medicina Reprodutiva Dr Carlos Isaia Filho |
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|
| Cyclobenzaprine with caffeine | Drug | The patient will take 2 tablets (combination of cyclobenzaprine and caffeine), oral, per day, each 12h |
|
|
| Porto Alegre |
| Rio Grande do Sul |
| Brazil |
| Allegisa | Campinas | São Paulo | 13.084-791 | Brazil |
| CECIP JAU - Centro De Estudos Clinicos do Interior Paulista | Jaú | São Paulo | Brazil |
| Marcio Antonio Pereira Clinica de Endocrinologia | São José dos Campos | São Paulo | Brazil |
| AFIP -Associação Fundo de Incentivo a Pesquisa | São Paulo | São Paulo | Brazil |
| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007660 | Ketoprofen |
| D002110 | Caffeine |
| C004704 | cyclobenzaprine |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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