ContusionsPhase 3SAL-SIP-03/09NCT00970658
Efficacy and Safety of Salonsip Compared to Sabiá Plaster
A Phase 3 study testing Salonsip plaster and Sabia plaster in people with Contusions and Sprains, run by Hisamitsu Farmaceutica do Brasil Ltda.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Contusions, Sprains, Myalgia
- What is being tested?
- Salonsip plaster and Sabia plaster
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Feb 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
About this study
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.
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
- Being tested
- Salonsip plaster, Sabia plaster
- Keywords
- Plaster, injuries, regions miofasciais articulated, Reducing signs, symptoms
- Medical subject headings
- Contusions, Sprains and Strains, Myalgia, Pain, Tendinopathy, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salonsip plasterDrug
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).
Sabia plasterDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Sabia plaster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Likert Scales and Visual Analogue Scales
Measured: two days
Secondary outcomes (1)
Safety evaluation by adverse events relate.
Measured: two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startDec 2009
- Primary completionJan 2010 (estimated)
- Study completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContusionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hisamitsu Farmaceutica do Brasil Ltda
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970658
- Sponsor's protocol ID
- SAL-SIP-03/09
- Acronym
- SAL-SIP-03/09
- Status last verified
- Sep 2009
- First submitted
- 1 Sep 2009
- Last updated
- 4 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00970658
- Acronym / sponsor ID
- SAL-SIP-03/09 / SAL-SIP-03/09
- Conditions
- Contusions, Sprains, Myalgia, Pain, Tendonitis
- Keywords
- Plaster, injuries, regions miofasciais articulated, Reducing signs, symptoms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hisamitsu Farmaceutica do Brasil LtdaIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Feb 2010 (estimated)
- First posted
- 2 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salonsip | Experimental | Drug: Salonsip plasterThe 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 | Active comparator | Drug: Sabia plasterThe 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). |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salonsip plasterThe 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 |
| Sabia plasterThe 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 | Sabiá |
Primary outcome
Likert Scales and Visual Analogue Scales
Time frame: two days
1 secondary outcome
Safety evaluation by adverse events relate.
Time frame: two days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Salonsip plaster and Sabia plaster in people with Contusions and Sprains, run by Hisamitsu Farmaceutica do Brasil Ltda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Likert Scales and Visual Analogue Scales (time frame: two days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2009.