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

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.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01097798

Acronym

LBB-ALI-01/09

Enrollment

120

Registered

2010-04-02

Start date

2010-06-30

Completion date

2010-08-31

Last updated

2010-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

muscle injury

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.

Interventions

DRUGGelol

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

DRUGAliviador

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the efficacy in reducing signs and symptoms Aliviador compared to Gelol.	two days	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

Measure	Time frame	Description
To evaluate the tolerability use Aliviador compared to Gelol.	two days	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.

Countries

Brazil

Contacts

Primary ContactAbel Pereira Junior, investigator principal

abelpsjr@terra.com.br55 11 49905244

Backup ContactSelma Squassoni, study coordinator

selma_denis@yahoo.com.br55 11 49935459

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026