To Evaluate the Efficacy and Safety Aliviador Compared to Gelol in Patients With Contusions, Sprains, Trauma and Muscle Injury.

Study Overview
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Brief Summary
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Multicenter, randomized, double-blind trial, to evaluate the efficacy and safety Aliviador compared to Gelol in the relief of signs and symptoms in patients with contusions, sprains, trauma and muscle injury start with less than 24 hours or patients of myalgia, myofascial pain and tendinitis.

Official Title
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Multicenter, Randomized, Double-blind Trial to Evaluate the Efficacy and Safety Aliviador Compared to Gelol in the Relief in Patients With Contusons, Sprains,Trauma and Muscle Injury.

Conditions
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Contusions, Sprains, Trauma, Muscle Injury, Myalgia, Myofascial Pain, Tendinitis

Intervention / Treatment
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* Drug: Aliviador
* Drug: Gelol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both sexes, of any race, aged over 12 years. Ability to read, understand and sign the IC, in the case of minors consent of responsible; Clinical diagnosis of bruises, sprains, trauma, muscle damage occurred in less than 24 hours or muscle pain, myofascial pain or tendinitis. Patients able to understand and maintain the clinical protocol. Exclusion Criteria: Known hypersensitivity to components of the formulas of both the drug test as the comparator. Known hypersensitivity to paracetamol. Location of the lesion with skin wound or irritated. Liver or kidney disease known. Pregnant or lactating women. Patients who require surgery or immobilization. Patients with fractures or rupture of the ligaments. Patients using anticoagulants. Patients with severe concomitant systemic diseases, such as cancer, diabetes, or acquired heart disease, hematological diseases, seizure disorders, autoimmune diseases, renal failure, severe infections, hormonal disorders and pulmonary disorders. History of alcoholism or illicit drug use; Use of NSAIDs, corticosteroids or venoterápicos, topics or any other form of administration. Conditions in the opinion of the researcher make the patient unsuitable to participate in the study.

Ages Eligible for Study
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Minimum Age: 12 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: Aliviador<br> | Drug: Aliviador<br>* The study medication should be applied regimen of 8/8 hours over 2 days.<br>|
| Active Comparator: Gelol<br> | Drug: Gelol<br>* The study medication should be applied regimen of 8/8 hours over 2 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy in reducing signs and symptoms Aliviador compared to Gelol. | To evaluate the efficacy in reducing signs and symptoms Aliviador compared to Gelol in patients with contusions, sprains, muscle injury and trauma, starting less than 24 hours or patients with muscle pain, myofascial pain and tendinitis. | two days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the tolerability use Aliviador compared to Gelol. | To evaluete the tolerability use Aliviador compared to Gelol in patients with contusions, sprains, muscle injury and traumas starting less than 24 hours or patients with myalgia, myofascial pain and tendinitis. | two days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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muscle injury