To Evaluate the Efficacy and Safety Aliviador Compared to Gelol in Patients With Contusions, Sprains, Trauma and Muscle Injury. (LBB-ALI-01/09)

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.

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.

Study Overview

• Status: Unknown
• Conditions: Myalgia; Trauma; Myofascial Pain; Sprains; Contusions; Tendinitis; Muscle Injury
• Intervention / Treatment: Drug: Aliviador; Drug: Gelol

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Abel Pereira Junior, investigator principal; Phone Number: 55 11 49905244; Email: abelpsjr@terra.com.br
• Study Contact Backup: Name: Selma Squassoni, study coordinator; Phone Number: 55 11 49935459; Email: selma_denis@yahoo.com.br

Study Locations

• Brazil
  • São Paulo, Brazil, 05005-001
    • Clínica Perdizes
    • Contact: Gilberto de Castro Brandão, investigator; Phone Number: 55 11 3825666; Email: gilbertobrandao@hotmail.com
  • São Paulo, Brazil
    • S.C. Corinthians Paulista
    • Contact: Paulo de Faria; Phone Number: 3146 55 11 20953000; Email: phfaria@uol.com.br
  • São Paulo
    • Santo André, São Paulo, Brazil, 09060-650
      • Faculdade de Medicina do ABC
      • Contact: Selma Squassoni, study coordinator; Phone Number: 55 11 49935459; Email: selma_denis@yahoo.com.br
      • Contact: Abel Pereira Junior, investigator; Phone Number: 55 11 49905244; Email: abelpsjr@terra.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aliviador	Drug: Aliviador; The study medication should be applied regimen of 8/8 hours over 2 days.
Active Comparator: Gelol	Drug: Gelol; The study medication should be applied regimen of 8/8 hours over 2 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the efficacy in reducing signs and symptoms Aliviador compared to Gelol.	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.	two days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the tolerability use Aliviador compared to Gelol.	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.	two days

Collaborators and Investigators

• Sponsor: Laboratorio Brasileiro de Biologia
• Investigators: Principal Investigator: Abel Pereira Junior, investigator, Faculdade de Medicina do ABC; Principal Investigator: Gilberto de Castro Brandão, investigator, Clínica Perdizes; Principal Investigator: Paulo Faria, investigator, S.C. Corinthians Paulista

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Anticipated): August 1, 2010
• Study Completion (Anticipated): August 1, 2010

Study Registration Dates

• First Submitted: April 1, 2010
• First Submitted That Met QC Criteria: April 1, 2010
• First Posted (Estimate): April 2, 2010

Study Record Updates

• Last Update Posted (Estimate): April 16, 2010
• Last Update Submitted That Met QC Criteria: April 15, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: muscle injury
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Tendon Injuries; Wounds, Nonpenetrating; Myalgia; Tendinopathy; Wounds and Injuries; Sprains and Strains; Contusions
• Other Study ID Numbers: LBB-ALI-01/09