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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
Hisamitsu Farmaceutica do Brasil Ltda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Contusions focused on measuring Plaster, injuries, regions miofasciais articulated, Reducing signs, symptoms

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 1, 2009
    Last Updated
    September 3, 2009
    Sponsor
    Hisamitsu Farmaceutica do Brasil Ltda
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    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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