Efficacy and Safety of Salonsip Compared to Sabiá Plaster

Phase 3

• Conditions: Myalgia; Sprains; Pain; Contusions; Tendonitis
• Interventions: Drug: Salonsip plaster; Drug: Sabia plaster

• Registration Number: NCT00970658
• Lead Sponsor: Hisamitsu Farmaceutica do Brasil Ltda

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-09
• Study First Submitted: 2009-09-01
• Study First Submitted QC: 2009-09-01
• Study First Posted: 2009-09-02
• Last Update Submitted: 2009-09-03
• Last Update Posted: 2009-09-04
• Study Start: 2009-12
• Primary Completion: 2010-01
• Study Completion: 2010-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Salonsip	Salonsip plaster	The 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).
Sabiá	Sabia plaster	The 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).

Primary Outcome Measures

Name	Time	Method
Likert Scales and Visual Analogue Scales	two days

Secondary Outcome Measures

Name	Time	Method
Safety evaluation by adverse events relate.	two days