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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Contusions; Sprains; Trauma; Muscle Injury; Myalgia; Myofascial Pain; Tendinitis	Drug: Aliviador; Drug: Gelol	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	120 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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 Start Date :	June 2010
Estimated Primary Completion Date :	August 2010
Estimated Study Completion Date :	August 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. To evaluate the efficacy in reducing signs and symptoms Aliviador compared to Gelol. [ Time Frame: 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 :

1. To evaluate the tolerability use Aliviador compared to Gelol. [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	12 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Abel Pereira Junior, investigator principal	55 11 49905244	abelpsjr@terra.com.br
Contact: Selma Squassoni, study coordinator	55 11 49935459	selma_denis@yahoo.com.br

Locations

Brazil
Faculdade de Medicina do ABC	Not yet recruiting
Santo André, São Paulo, Brazil, 09060-650
Contact: Abel Pereira Junior, investigator 55 11 49905244 abelpsjr@terra.com.br
Contact: Selma Squassoni, study coordinator 55 11 49935459 selma_denis@yahoo.com.br
Clínica Perdizes	Not yet recruiting
São Paulo, Brazil, 05005-001
Contact: Gilberto de Castro Brandão, investigator 55 11 3825666 gilbertobrandao@hotmail.com
S.C. Corinthians Paulista	Not yet recruiting
São Paulo, Brazil
Contact: Paulo de Faria 55 11 20953000 ext 3146 phfaria@uol.com.br

Sponsors and Collaborators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Maria Lygia Bezerra, Laboratório Brasileiro de Biologia
ClinicalTrials.gov Identifier:	NCT01097798 History of Changes
Other Study ID Numbers:	LBB-ALI-01/09
First Posted:	April 2, 2010
Last Update Posted:	April 16, 2010
Last Verified:	February 2010

Keywords provided by Laboratorio Brasileiro de Biologia:

muscle injury

Additional relevant MeSH terms:

Wounds and Injuries; Sprains and Strains; Tendinopathy; Myalgia; Contusions; Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries	Musculoskeletal Pain; Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Signs and Symptoms; Wounds, Nonpenetrating