Efficacy and Safety of Salonsip Compared to Sabiá Plaster

Pain Clinical Trial

— SAL-SIP-03/09  

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00970658
• Other study ID #: SAL-SIP-03/09
• Status: Not yet recruiting
• Phase: Phase 3
• First received: September 1, 2009
• Last updated: September 3, 2009
• Start date: December 2009
• Est. completion date: February 2010

Study information

• Verified date: September 2009
• Source: Hisamitsu Farmaceutica do Brasil Ltda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: February 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contusions
• Myalgia
• Pain
• Sprains
• Tendonitis

Intervention

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).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hisamitsu Farmaceutica do Brasil Ltda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Likert Scales and Visual Analogue Scales		two days	Yes
Secondary	Safety evaluation by adverse events relate.		two days	Yes