Efficacy and Safety of Salonsip Compared to Sabiá Plaster (SAL-SIP-03/09)

Clinical Multicenter Study, Randomized, Open, to Evaluate the Efficacy and Safety of Salonsip Compared to Sabiá Plaster Relief of the Signs and Symptoms in Patients With Contusions, Sprains, Injuries and Muscular Injuries With Less Than 24 Hours Early or Holders of Myalgia, Pain and Tendonitis in Regions Miofasciais Articulated.

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Myalgia; Sprains; Contusions; Tendonitis
• Intervention / Treatment: Drug: Salonsip plaster; Drug: Sabia plaster

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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).	Drug: 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).
ACTIVE_COMPARATOR: 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).	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Likert Scales and Visual Analogue Scales	two days

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety evaluation by adverse events relate.	two days

Collaborators and Investigators

• Sponsor: Hisamitsu Farmaceutica do Brasil Ltda

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (ANTICIPATED): January 1, 2010
• Study Completion (ANTICIPATED): February 1, 2010

Study Registration Dates

• First Submitted: September 1, 2009
• First Submitted That Met QC Criteria: September 1, 2009
• First Posted (ESTIMATE): September 2, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): September 4, 2009
• Last Update Submitted That Met QC Criteria: September 3, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Plaster; injuries; regions miofasciais articulated; Reducing signs, symptoms
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Tendon Injuries; Wounds, Nonpenetrating; Myalgia; Tendinopathy; Sprains and Strains; Contusions
• Other Study ID Numbers: SAL-SIP-03/09