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ClinicalTrials.gov ID

NCT01097798

Lead Sponsor

Laboratorio Brasileiro de BiologiaOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 3

Enrollment

120Estimated

Last Update Posted

Apr 16, 2010Estimated

Start Date

Jun 2010

Primary Completion Date

Aug 2010Estimated

Completion Date

Aug 2010Estimated

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.

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.

• Contusions
• Sprains
• Trauma
• Muscle Injury
• Myalgia
• Myofascial Pain
• Tendinitis

• Aliviador
• Gelol

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Laboratorio Brasileiro de BiologiaOTHER

gilbertobrandao@hotmail.com55 11 3825666

phfaria@uol.com.br55 11 20953000 ext. 3146