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

NCT01097798 | Unknown Phase 3 DMC

• 1 other identifier: LBB-ALI-01/09
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Contusions; Sprains; Trauma; Muscle Injury; Myalgia; Myofascial Pain; Tendinitis

Keywords

muscle injury

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• To evaluate the tolerability use Aliviador compared to Gelol.

  two days

Study Arms (2)

Aliviador

EXPERIMENTAL

Drug: Aliviador

Gelol

ACTIVE COMPARATOR

Drug: Gelol

Interventions

Aliviador DRUG

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

Aliviador

Gelol DRUG

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

Gelol

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratorio Brasileiro de Biologia: lead

Study Sites (3)

Faculdade de Medicina do ABC

Santo André, São Paulo, 09060-650, Brazil

Location

Clínica Perdizes

São Paulo, São Paulo, 05005-001, Brazil

Location

S.C. Corinthians Paulista

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Contusions; Sprains and Strains; Wounds and Injuries; Myalgia; Tendinopathy

Condition Hierarchy (Ancestors)

Wounds, Nonpenetrating; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tendon Injuries

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abel Pereira Junior, investigator principal

CONTACT

55 11 49905244; abelpsjr@terra.com.br

Selma Squassoni, study coordinator

CONTACT

55 11 49935459; selma_denis@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 2, 2010
• Study Start: June 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: April 16, 2010

Record last verified: 2010-02

Locations

BR (3)