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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Laboratorio Brasileiro de Biologia.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Laboratorio Brasileiro de Biologia
ClinicalTrials.gov Identifier:
NCT01097798
First received: April 1, 2010
Last updated: April 15, 2010
Last verified: February 2010
  Purpose

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 Intervention Phase
Contusions
Sprains
Trauma
Muscle Injury
Myalgia
Myofascial Pain
Tendinitis
Drug: Aliviador
Drug: Gelol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Laboratorio Brasileiro de Biologia:

Primary Outcome Measures:
  • To evaluate the efficacy in reducing signs and symptoms Aliviador compared to Gelol. [ Time Frame: two days ] [ Designated as safety issue: Yes ]
    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:
  • To evaluate the tolerability use Aliviador compared to Gelol. [ Time Frame: two days ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 120
Study Start Date: June 2010
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Maria Lygia Bezerra, Laboratório Brasileiro de Biologia
ClinicalTrials.gov Identifier: NCT01097798     History of Changes
Other Study ID Numbers: LBB-ALI-01/09
Study First Received: April 1, 2010
Last Updated: April 15, 2010
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Laboratorio Brasileiro de Biologia:
muscle injury

Additional relevant MeSH terms:
Contusions
Sprains and Strains
Tendinopathy
Wounds and Injuries
Myalgia
Myofascial Pain Syndromes
Wounds, Nonpenetrating
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Musculoskeletal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on August 28, 2014