Efficacy and Safety of Salonsip Compared to Sabiá Plaster

NCT00970658 | Unknown Phase 3 DMC

• 1 other identifier: SAL-SIP-03/09
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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

Keywords

Plaster; injuries; regions miofasciais articulated; Reducing signs, symptoms

Outcome Measures

Primary Outcomes (1)

• Likert Scales and Visual Analogue Scales

  two days

Secondary Outcomes (1)

• Safety evaluation by adverse events relate.

  two days

Study Arms (2)

Salonsip

EXPERIMENTAL

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

Sabiá

ACTIVE COMPARATOR

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

Interventions

Salonsip plaster 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).

Salonsip

Sabia plaster 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

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hisamitsu Farmaceutica do Brasil Ltda: lead

MeSH Terms

Conditions

Contusions; Sprains and Strains; Myalgia; Pain; Tendinopathy; Wounds and Injuries

Condition Hierarchy (Ancestors)

Wounds, Nonpenetrating; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 1, 2009
• First Posted: September 2, 2009
• Study Start: December 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: February 1, 2010
• Last Updated: September 4, 2009

Record last verified: 2009-09