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

Trauma Clinical Trial

— 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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01097798
• Other study ID #: LBB-ALI-01/09
• Status: Not yet recruiting
• Phase: Phase 3
• First received: April 1, 2010
• Last updated: April 15, 2010
• Start date: June 2010
• Est. completion date: August 2010

Study information

• Verified date: February 2010
• Source: Laboratorio Brasileiro de Biologia
• Contact: Abel Pereira Junior, investigator principal
• Phone: 55 11 49905244
• Email: abelpsjr[@]terra.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contusions
• Muscle Injury
• Myalgia
• Myofascial Pain
• Sprains
• Tendinitis
• Trauma
• Wounds and Injuries

Intervention

Drug:
• Aliviador
The study medication should be applied regimen of 8/8 hours over 2 days.
• Gelol
The study medication should be applied regimen of 8/8 hours over 2 days.

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina do ABC	Santo André	São Paulo
Brazil	Clínica Perdizes	São Paulo
Brazil	S.C. Corinthians Paulista	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorio Brasileiro de Biologia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	two days	Yes
Secondary	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.	two days	Yes