Clinical trial NCT01097798: To Evaluate the Efficacy and Safety Aliviador Compared to Gelol in Patients With Contusions, Sprains, Trauma and Muscle Injury.
Official title: Multicenter, Randomized, Double-blind Trial to Evaluate the Efficacy and Safety Aliviador Compared to Gelol in the Relief in Patients With Contusons, Sprains,Trauma and Muscle Injury.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Contusions
Sprains
Trauma
Muscle Injury
Myalgia
Myofascial Pain
Tendinitis
Keywords: muscle injury
Lead sponsor: Laboratorio Brasileiro de Biologia
Sponsor class: OTHER
First posted: 2010-04-02
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multicenter, randomized, double-blind trial, to evaluate the efficacy and safety Aliviador compared to Gelol in the relief of signs and symptoms in patients with contusions, sprains, trauma and muscle injury start with less than 24 hours or patients of myalgia, myofascial pain and tendinitis.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes, of any race, aged over 12 years.
* Ability to read, understand and sign the IC, in the case of minors consent of responsible;
* Clinical diagnosis of bruises, sprains, trauma, muscle damage occurred in less than 24 hours or muscle pain, myofascial pain or tendinitis.
* Patients able to understand and maintain the clinical protocol.

Exclusion Criteria:

* Known hypersensitivity to components of the formulas of both the drug test as the comparator.
* Known hypersensitivity to paracetamol.
* Location of the lesion with skin wound or irritated.
* Liver or kidney disease known.
* Pregnant or lactating women.
* Patients who require surgery or immobilization.
* Patients with fractures or rupture of the ligaments.
* Patients using anticoagulants.
* Patients with severe concomitant systemic diseases, such as cancer, diabetes, or acquired heart disease, hematological diseases, seizure disorders, autoimmune diseases, renal failure, severe infections, hormonal disorders and pulmonary disorders.
* History of alcoholism or illicit drug use;
* Use of NSAIDs, corticosteroids or venoterápicos, topics or any other form of administration.
* Conditions in the opinion of the researcher make the patient unsuitable to participate in the study.

Primary outcomes:
measure: To evaluate the efficacy in reducing signs and symptoms Aliviador compared to Gelol.
timeFrame: two days
Secondary outcomes:
measure: To evaluate the tolerability use Aliviador compared to Gelol.
timeFrame: two days
Other outcomes:
Locations:
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC
state: São Paulo
city: São Paulo
country: Brazil
facility: Clínica Perdizes
city: São Paulo
country: Brazil
facility: S.C. Corinthians Paulista
Study officials:
affiliation: Faculdade de Medicina do ABC
name: Abel Pereira Junior, investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: Clínica Perdizes
name: Gilberto de Castro Brandão, investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: S.C. Corinthians Paulista
name: Paulo Faria, investigator
role: PRINCIPAL_INVESTIGATOR
References: