Back to resultsTo Evaluate the Efficacy and Safety Aliviador Compared to Gelol in Patients With Contusions, Sprains, Trauma and Muscle Injury. (LBB-ALI-01/09)
Primary Purpose
Contusions, Sprains, Trauma
Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Aliviador
Gelol
Sponsored by
About this trial
This is an interventional treatment trial for Contusions focused on measuring muscle injury
Eligibility 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.
Sites / Locations
- Faculdade de Medicina do ABC
- Clínica Perdizes
- S.C. Corinthians Paulista
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Aliviador
Gelol
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01097798
First Posted
April 1, 2010
Last Updated
April 15, 2010
Sponsor
Laboratorio Brasileiro de Biologia
1. Study Identification
Unique Protocol Identification Number
NCT01097798
Brief Title
To Evaluate the Efficacy and Safety Aliviador Compared to Gelol in Patients With Contusions, Sprains, Trauma and Muscle Injury.
Acronym
LBB-ALI-01/09
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 Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
August 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Laboratorio Brasileiro de Biologia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contusions, Sprains, Trauma, Muscle Injury, Myalgia, Myofascial Pain, Tendinitis
Keywords
muscle injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aliviador
Arm Type
Experimental
Arm Title
Gelol
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Aliviador
Intervention Description
The study medication should be applied regimen of 8/8 hours over 2 days.
Intervention Type
Drug
Intervention Name(s)
Gelol
Intervention Description
The study medication should be applied regimen of 8/8 hours over 2 days.
Primary Outcome Measure Information:
Title
To evaluate the efficacy in reducing signs and symptoms Aliviador compared to Gelol.
Description
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.
Time Frame
two days
Secondary Outcome Measure Information:
Title
To evaluate the tolerability use Aliviador compared to Gelol.
Description
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.
Time Frame
two days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abel Pereira Junior, investigator principal
Phone
55 11 49905244
Email
abelpsjr@terra.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Selma Squassoni, study coordinator
Phone
55 11 49935459
Email
selma_denis@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abel Pereira Junior, investigator
Organizational Affiliation
Faculdade de Medicina do ABC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gilberto de Castro Brandão, investigator
Organizational Affiliation
Clínica Perdizes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paulo Faria, investigator
Organizational Affiliation
S.C. Corinthians Paulista
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculdade de Medicina do ABC
City
Santo André
State/Province
São Paulo
ZIP/Postal Code
09060-650
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abel Pereira Junior, investigator
Phone
55 11 49905244
Email
abelpsjr@terra.com.br
First Name & Middle Initial & Last Name & Degree
Selma Squassoni, study coordinator
Phone
55 11 49935459
Email
selma_denis@yahoo.com.br
Facility Name
Clínica Perdizes
City
São Paulo
ZIP/Postal Code
05005-001
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilberto de Castro Brandão, investigator
Phone
55 11 3825666
Email
gilbertobrandao@hotmail.com
Facility Name
S.C. Corinthians Paulista
City
São Paulo
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paulo de Faria
Phone
55 11 20953000
Ext
3146
Email
phfaria@uol.com.br
12. IPD Sharing Statement
Learn more about this trial
To Evaluate the Efficacy and Safety Aliviador Compared to Gelol in Patients With Contusions, Sprains, Trauma and Muscle Injury.
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