Efficacy and Safety of Salonsip Compared to Sabiá Plaster

NCT ID: NCT00970658

Last Updated: 2009-09-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2010-02-28

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.

Conditions

Contusions; Sprains; Myalgia; Pain; Tendonitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Salonsip

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).

Group Type: EXPERIMENTAL

Salonsip plaster

Intervention Type: DRUG

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

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).

Group Type: ACTIVE_COMPARATOR

Sabia plaster

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

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).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hisamitsu Farmaceutica do Brasil Ltda

INDUSTRY

Sponsor Role: lead

Responsible Party

Hisamitsu Farmacêutica do Brasil Ltda.

Other Identifiers

SAL-SIP-03/09

Identifier Type: -

Identifier Source: org_study_id