Efficacy and Safety of Salonsip Compared to Sabiá Plaster (SAL-SIP-03/09)
Primary Purpose
Contusions, Sprains, Myalgia
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Salonsip plaster
Sabia plaster
Sponsored by
About this trial
This is an interventional treatment trial for Contusions focused on measuring Plaster, injuries, regions miofasciais articulated, Reducing signs, symptoms
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Salonsip
Sabiá
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
Likert Scales and Visual Analogue Scales
Secondary Outcome Measures
Safety evaluation by adverse events relate.
Full Information
NCT ID
NCT00970658
First Posted
September 1, 2009
Last Updated
September 3, 2009
Sponsor
Hisamitsu Farmaceutica do Brasil Ltda
1. Study Identification
Unique Protocol Identification Number
NCT00970658
Brief Title
Efficacy and Safety of Salonsip Compared to Sabiá Plaster
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
February 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hisamitsu Farmaceutica do Brasil Ltda
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contusions, Sprains, Myalgia, Pain, Tendonitis
Keywords
Plaster, injuries, regions miofasciais articulated, Reducing signs, symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Salonsip
Arm Type
Experimental
Arm Description
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).
Arm Title
Sabiá
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Salonsip plaster
Intervention Description
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
Intervention Name(s)
Sabia plaster
Intervention Description
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 Measure Information:
Title
Likert Scales and Visual Analogue Scales
Time Frame
two days
Secondary Outcome Measure Information:
Title
Safety evaluation by adverse events relate.
Time Frame
two days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Salonsip Compared to Sabiá Plaster
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