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
Recruitment status was Not yet recruiting
Sponsor:
Hisamitsu Farmaceutica do Brasil Ltda
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
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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
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 Sprains and Strains Tendinopathy Wounds and Injuries |
Wounds, Nonpenetrating Muscular Diseases Musculoskeletal Diseases Tendon Injuries |
ClinicalTrials.gov processed this record on May 23, 2013