To Evaluate the Efficacy and Safety Aliviador Compared to Gelol in Patients With Contusions, Sprains, Trauma and Muscle Injury. (LBB-ALI-01/09)
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ClinicalTrials.gov Identifier: NCT01097798 |
Recruitment Status : Unknown
Verified February 2010 by Laboratorio Brasileiro de Biologia.
Recruitment status was: Not yet recruiting
First Posted : April 2, 2010
Last Update Posted : April 16, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Contusions Sprains Trauma Muscle Injury Myalgia Myofascial Pain Tendinitis | Drug: Aliviador Drug: Gelol | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 Start Date : | June 2010 |
Estimated Primary Completion Date : | August 2010 |
Estimated Study Completion Date : | August 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Aliviador |
Drug: Aliviador
The study medication should be applied regimen of 8/8 hours over 2 days. |
Active Comparator: Gelol |
Drug: Gelol
The study medication should be applied regimen of 8/8 hours over 2 days. |
- To evaluate the efficacy in reducing signs and symptoms Aliviador compared to Gelol. [ Time Frame: 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.
- To evaluate the tolerability use Aliviador compared to Gelol. [ Time Frame: 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.

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097798
Contact: Abel Pereira Junior, investigator principal | 55 11 49905244 | abelpsjr@terra.com.br | |
Contact: Selma Squassoni, study coordinator | 55 11 49935459 | selma_denis@yahoo.com.br |
Brazil | |
Faculdade de Medicina do ABC | |
Santo André, São Paulo, Brazil, 09060-650 | |
Contact: Abel Pereira Junior, investigator 55 11 49905244 abelpsjr@terra.com.br | |
Contact: Selma Squassoni, study coordinator 55 11 49935459 selma_denis@yahoo.com.br | |
Clínica Perdizes | |
São Paulo, Brazil, 05005-001 | |
Contact: Gilberto de Castro Brandão, investigator 55 11 3825666 gilbertobrandao@hotmail.com | |
S.C. Corinthians Paulista | |
São Paulo, Brazil | |
Contact: Paulo de Faria 55 11 20953000 ext 3146 phfaria@uol.com.br |
Principal Investigator: | 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 |
Responsible Party: | Maria Lygia Bezerra, Laboratório Brasileiro de Biologia |
ClinicalTrials.gov Identifier: | NCT01097798 |
Other Study ID Numbers: |
LBB-ALI-01/09 |
First Posted: | April 2, 2010 Key Record Dates |
Last Update Posted: | April 16, 2010 |
Last Verified: | February 2010 |
muscle injury |
Tendinopathy Myalgia Wounds and Injuries Sprains and Strains Contusions Muscular Diseases Musculoskeletal Diseases |
Tendon Injuries Neuromuscular Diseases Nervous System Diseases Musculoskeletal Pain Pain Neurologic Manifestations Wounds, Nonpenetrating |