To Evaluate the Efficacy and Safety Aliviador Compared to Gelol in Patients With Contusions, Sprains, Trauma and Muscle Injury.

NCT ID: NCT01097798

Last Updated: 2010-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Contusions Sprains Trauma Muscle Injury Myalgia Myofascial Pain Tendinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Aliviador

Group Type EXPERIMENTAL

Aliviador

Intervention Type DRUG

The study medication should be applied regimen of 8/8 hours over 2 days.

Gelol

Group Type ACTIVE_COMPARATOR

Gelol

Intervention Type DRUG

The study medication should be applied regimen of 8/8 hours over 2 days.

Interventions

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Aliviador

The study medication should be applied regimen of 8/8 hours over 2 days.

Intervention Type DRUG

Gelol

The study medication should be applied regimen of 8/8 hours over 2 days.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratorio Brasileiro de Biologia

OTHER

Sponsor Role lead

Responsible Party

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Laboratório Brasileiro de Biologia

Principal Investigators

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Abel Pereira Junior, investigator

Role: PRINCIPAL_INVESTIGATOR

Faculdade de Medicina do ABC

Gilberto de Castro Brandão, investigator

Role: PRINCIPAL_INVESTIGATOR

Clínica Perdizes

Paulo Faria, investigator

Role: PRINCIPAL_INVESTIGATOR

S.C. Corinthians Paulista

Locations

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Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

Site Status

Clínica Perdizes

São Paulo, São Paulo, Brazil

Site Status

S.C. Corinthians Paulista

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Abel Pereira Junior, investigator principal

Role: CONTACT

55 11 49905244

Selma Squassoni, study coordinator

Role: CONTACT

55 11 49935459

Facility Contacts

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Abel Pereira Junior, investigator

Role: primary

55 11 49905244

Selma Squassoni, study coordinator

Role: backup

55 11 49935459

Gilberto de Castro Brandão, investigator

Role: primary

55 11 3825666

Paulo de Faria

Role: primary

55 11 20953000 ext. 3146

Other Identifiers

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LBB-ALI-01/09

Identifier Type: -

Identifier Source: org_study_id

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