To Evaluate the Efficacy and Safety Aliviador Compared to Gelol in Patients With Contusions, Sprains, Trauma and Muscle Injury.
NCT ID: NCT01097798
Last Updated: 2010-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
120 participants
INTERVENTIONAL
2010-06-30
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Aliviador
Aliviador
The study medication should be applied regimen of 8/8 hours over 2 days.
Gelol
Gelol
The study medication should be applied regimen of 8/8 hours over 2 days.
Interventions
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Aliviador
The study medication should be applied regimen of 8/8 hours over 2 days.
Gelol
The study medication should be applied regimen of 8/8 hours over 2 days.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
12 Years
ALL
No
Sponsors
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Laboratorio Brasileiro de Biologia
OTHER
Responsible Party
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Laboratório Brasileiro de Biologia
Principal Investigators
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Abel Pereira Junior, investigator
Role: PRINCIPAL_INVESTIGATOR
Faculdade de Medicina do ABC
Gilberto de Castro Brandão, investigator
Role: PRINCIPAL_INVESTIGATOR
Clínica Perdizes
Paulo Faria, investigator
Role: PRINCIPAL_INVESTIGATOR
S.C. Corinthians Paulista
Locations
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Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil
Clínica Perdizes
São Paulo, São Paulo, Brazil
S.C. Corinthians Paulista
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LBB-ALI-01/09
Identifier Type: -
Identifier Source: org_study_id
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