To Evaluate the Efficacy and Safety Aliviador Compared to Gelol in Patients With Contusions, Sprains, Trauma and Muscle Injury.

Phase 3

• Conditions: Contusions; Sprains; Trauma; Muscle Injury; Myalgia; Myofascial Pain; Tendinitis
• Interventions: Drug: Aliviador; Drug: Gelol

• Registration Number: NCT01097798
• Lead Sponsor: Laboratorio Brasileiro de Biologia

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-02
• Study First Submitted: 2010-04-01
• Study First Submitted QC: 2010-04-01
• Study First Posted: 2010-04-02
• Last Update Submitted: 2010-04-15
• Last Update Posted: 2010-04-16
• Study Start: 2010-06
• Primary Completion: 2010-08
• Study Completion: 2010-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aliviador	Aliviador	-
Gelol	Gelol	-

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy in reducing signs and symptoms Aliviador compared to Gelol.	two days	To evaluate the efficacy in reducing signs and symptoms Aliviador compared to Gelol in patients with contusions, sprains, muscle injury and trauma, starting less than 24 hours or patients with muscle pain, myofascial pain and tendinitis.

Secondary Outcome Measures

Name	Time	Method
To evaluate the tolerability use Aliviador compared to Gelol.	two days	To evaluete the tolerability use Aliviador compared to Gelol in patients with contusions, sprains, muscle injury and traumas starting less than 24 hours or patients with myalgia, myofascial pain and tendinitis.

Trial Locations

Locations (3)

Faculdade de Medicina do ABC; 🇧🇷 Santo André, São Paulo, Brazil

Clínica Perdizes; 🇧🇷 São Paulo, Brazil

S.C. Corinthians Paulista; 🇧🇷 São Paulo, Brazil