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

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ClinicalTrials.gov Identifier: NCT01097798
Recruitment Status : Unknown
Verified February 2010 by Laboratorio Brasileiro de Biologia.
Recruitment status was:  Not yet recruiting
First Posted : April 2, 2010
Last Update Posted : April 16, 2010
Sponsor:
Information provided by:
Laboratorio Brasileiro de Biologia

Study Description
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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

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Arms and Interventions
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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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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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097798


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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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    Key Record Dates
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