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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Hisamitsu Farmaceutica do Brasil Ltda.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hisamitsu Farmaceutica do Brasil Ltda
ClinicalTrials.gov Identifier:
NCT00970658
First received: September 1, 2009
Last updated: September 3, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Contusions
Sprains
Myalgia
Pain
Tendonitis
Drug: Salonsip plaster
Drug: Sabia plaster
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Hisamitsu Farmaceutica do Brasil Ltda:

Primary Outcome Measures:
  • Likert Scales and Visual Analogue Scales [ Time Frame: two days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety evaluation by adverse events relate. [ Time Frame: two days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: December 2009
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Emília Wakebe, Hisamitsu Farmacêutica do Brasil Ltda.
ClinicalTrials.gov Identifier: NCT00970658     History of Changes
Other Study ID Numbers: SAL-SIP-03/09
Study First Received: September 1, 2009
Last Updated: September 3, 2009
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Hisamitsu Farmaceutica do Brasil Ltda:
Plaster
injuries
regions miofasciais articulated
Reducing signs, symptoms

Additional relevant MeSH terms:
Contusions
Myalgia
Muscular Diseases
Musculoskeletal Diseases
Musculoskeletal Pain
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Wounds and Injuries
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on November 25, 2014