Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine and Caffeine in Osteomuscular Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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Double-blind,randomized, multicenter Maximal experiment duration: 9 days 02 or 03 visits and a phone contact Evaluate the efficacy of an association with one anti-inflammatory and one muscle relaxant agent with caffeine compared to the one muscle relaxant agent plus caffeine in the treatment of osteomuscular pain in adults. Adverse events evaluation

Official Title
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Phase III, National, Multicenter, Randomized, Double-blind, Double-masked, Compare the Efficacy of Ketoprofen, Cyclobenzaprine and Caffeine Association Versus Cyclobenzaprine and Caffeine (Miosan Caf®) in the Treatment of Osteomuscular Pain in Adults

Conditions
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Musculoskeletal Pain

Intervention / Treatment
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* Drug: ketoprofen and cyclobenzaprine association with caffeine
* Drug: Cyclobenzaprine with caffeine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Consent of the patient; Participants presenting musculoskeletal pain, moderate or moderately severe, with VAS (visual analog scale) greater than 40 mm for a period of less than seven (7) days. Exclusion Criteria: Patients with any clinically significant disease that in the investigator is opinion can´t participate in the study; Patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial; Patients with history of hypersensitivity to any of the formula compounds; Participation in clinical trial in the year prior to this study; Pregnancy or risk of pregnancy and lactating patients; Patients who were in use of drugs that can interfere with evaluation; History of with rheumatic diseases, fibromyalgia, osteoarticular diseases, dystonia, dystrophies and myopathies, acute infectious diseases, gastric duodenal ulcer or gastritis; Renal or hepatic impairment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EMS association<br>The patient will take 2 tablets (combination of ketoprofen and cyclobenzaprine and caffeine), oral, per day, each 12h. | Drug: ketoprofen and cyclobenzaprine association with caffeine<br>* The patient will take 2 tablets (combination of ketoprofen and cyclobenzaprine and caffeine), oral, per day, each 12h<br>* Other names: EMS association;|
| Active Comparator: Miosan Caf®<br>The patient will take 2 tablets (combination of Cyclobenzaprine and caffeine), oral, per day, each 12h. | Drug: Cyclobenzaprine with caffeine<br>* The patient will take 2 tablets (combination of cyclobenzaprine and caffeine), oral, per day, each 12h<br>* Other names: Miosan Caf®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be evaluated by the adverse events occurrences |  | Maximal experiment duration: 9 days |