Contusions | Efficacy and Safety of Salonsip Compared to Sabiá Plaster
Contusions research study
What is the primary objective of this study?
The purpose of this study is to evaluate the efficacy in reducing signs and symptoms in patients with contusions, sprains, muscular injuries and injuries with less than 24 hours early or holders of myalgia, pain and tendonitis in regions miofasciais articulated with Salonsip compared to Sabiá plaster. It is clinical, open, multicenter, randomized, prospective and comparative, with patients entering at random. Patients will be included in sufficient quantity to achieve the minimum number of 70 evaluable patients.
Who is eligible to participate?
Inclusion Criteria: - Patients of both sexes, of any race, aged 12 years; - Ability to read, understand and sign the Consent Form, in the case of children under age monitoring and consent of the person responsible; - Clinical diagnosis of bruises, sprains, trauma, muscle damage occurring in times less than 24 hours or myalgia, pain miofasciais or tendonitis. - Patients able to understand and maintain the clinical protocol Exclusion Criteria: - Known hypersensitivity to components of the formulas of both the product and the comparative test. - Known hypersensitivity to paracetamol. - Location of the lesion with skin wound or irritated. - Hepatic or renal diseases known. - Pregnant or breastfeeding. - Patients who require surgery or immobilization rigid; - Patients with fractures or rupture of the ligaments. - Patients in use of anticoagulants. - Patients with severe concomitant systemic diseases such as cancer, diabetes, congenital or acquired heart disease, hematological diseases, convulsive disorders, autoimmune diseases, renal failure, infections, hormonal disorders and pulmonary disorders. - History of alcoholism or use of illicit drugs; - Use of non-steroidal anti-inflammatory drugs, corticosteroids or venoterápicos, topics or any other form of administration. - Conditions which in the opinion of the investigator makes 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:Salonsip plasterThe plaster should be applied at the site of injury, which must be clean and dry and changed every 8 hours for a period of 48 hours of treatment (2 days).
Drug:Sabia plasterThe plaster should be applied at the site of injury, which must be clean and dry and changed every 8 hours for a period of 48 hours of treatment (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.
SalonsipThe plaster should be applied at the site of injury, which must be clean and dry and changed every 8 hours for a period of 48 hours of treatment (2 days).
SabiáThe plaster should be applied at the site of injury, which must be clean and dry and changed every 8 hours for a period of 48 hours of treatment (2 days).
Start Date: December 2009
Completed Date: February 2010
Phase: Phase 3
Primary Outcome: Likert Scales and Visual Analogue Scales
Secondary Outcome: Safety evaluation by adverse events relate.
Study sponsors, principal investigator, and references
Lead Sponsor: Hisamitsu Farmaceutica do Brasil Ltda