Contusions | To Evaluate the Efficacy and Safety Aliviador Compared to Gelol in Patients With Contusions, Sprains, Trauma and Muscle Injury.
Contusions research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:AliviadorThe study medication should be applied regimen of 8/8 hours over 2 days.
Drug:GelolThe study medication should be applied regimen of 8/8 hours over 2 days.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: June 2010
Completed Date: August 2010
Phase: Phase 3
Primary Outcome: To evaluate the efficacy in reducing signs and symptoms Aliviador compared to Gelol.
Secondary Outcome: To evaluate the tolerability use Aliviador compared to Gelol.
Study sponsors, principal investigator, and references
Principal Investigator: Abel Pereira Junior, investigator
Lead Sponsor: Laboratorio Brasileiro de Biologia