ClinicalTrials.gg
Status unknownNCT00970658SAL-SIP-03/09Updated Sep 4, 2009

Efficacy and Safety of Salonsip Compared to Sabiá Plaster

A Phase 3 interventional study of Salonsip plaster and Sabia plaster in Contusions, Sprains and Myalgia, sponsored by Hisamitsu Farmaceutica do Brasil Ltda. Status unknown. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2009-09-04.

Sponsored by Hisamitsu Farmaceutica do Brasil Ltda · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2009), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Contusions
  • Sprains
  • Myalgia
  • Pain
  • Tendonitis

Keywords

  • Plaster
  • injuries
  • regions miofasciais articulated
  • Reducing signs, symptoms
03

In context

Contusions

43 studies on the registry are indexed under Contusions; 8 are open to participants now.

This study's planned enrollment of 70 is below the median of 90 across 31 interventional studies indexed under Contusions.

Browse Contusions studies →

Lead sponsor

This is the only study on the registry with Hisamitsu Farmaceutica do Brasil Ltda as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Known 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, diseases, renal failure, infections, hormonal disorders and pulmonary disorders.
  • History of alcoholism or use of illicit drugs;
  • Use of non-steroidal anti-inflammatory drugs, 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugSalonsip 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).

  • DrugSabia 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).

06

What researchers measure

Primary outcomes

  1. Likert Scales and Visual Analogue Scales

    Time frame: two days

Secondary outcomes

  1. Safety evaluation by adverse events relate.

    Time frame: two days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00970658
Lead sponsor
Hisamitsu Farmaceutica do Brasil Ltda
First posted
Sep 2, 2009
Start date
Dec 2009
Primary completion
Jan 2010 (estimated)
Completion
Feb 2010 (estimated)
Last update
Sep 4, 2009

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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