To Evaluate the Efficacy and Safety Aliviador Compared to Gelol in Patients With Contusions, Sprains, Trauma and Muscle Injury. (LBB-ALI-01/09)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Laboratorio Brasileiro de Biologia.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Laboratorio Brasileiro de Biologia
Information provided by:
Laboratorio Brasileiro de Biologia
ClinicalTrials.gov Identifier:
NCT01097798
First received: April 1, 2010
Last updated: April 15, 2010
Last verified: February 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Contusions Sprains Trauma Muscle Injury Myalgia Myofascial Pain Tendinitis |
Drug: Aliviador Drug: Gelol |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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. |
Resource links provided by NLM:
Further study details as provided by Laboratorio Brasileiro de Biologia:
Primary Outcome Measures:
- To evaluate the efficacy in reducing signs and symptoms Aliviador compared to Gelol. [ Time Frame: two days ] [ Designated as safety issue: Yes ]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 Outcome Measures:
- To evaluate the tolerability use Aliviador compared to Gelol. [ Time Frame: two days ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 120 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097798
Contacts
| 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 |
Locations
| Brazil | |
| Faculdade de Medicina do ABC | Not yet recruiting |
| 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 | Not yet recruiting |
| São Paulo, Brazil, 05005-001 | |
| Contact: Gilberto de Castro Brandão, investigator 55 11 3825666 gilbertobrandao@hotmail.com | |
| S.C. Corinthians Paulista | Not yet recruiting |
| São Paulo, Brazil | |
| Contact: Paulo de Faria 55 11 20953000 ext 3146 phfaria@uol.com.br | |
Sponsors and Collaborators
Laboratorio Brasileiro de Biologia
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Maria Lygia Bezerra, Laboratório Brasileiro de Biologia |
| ClinicalTrials.gov Identifier: | NCT01097798 History of Changes |
| Other Study ID Numbers: | LBB-ALI-01/09 |
| Study First Received: | April 1, 2010 |
| Last Updated: | April 15, 2010 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by Laboratorio Brasileiro de Biologia:
|
muscle injury |
Additional relevant MeSH terms:
|
Contusions Sprains and Strains Tendinopathy Wounds and Injuries Myofascial Pain Syndromes |
Wounds, Nonpenetrating Muscular Diseases Musculoskeletal Diseases Tendon Injuries |
ClinicalTrials.gov processed this record on May 23, 2013