ContusionsPhase 3LBB-ALI-01/09NCT01097798
To Evaluate the Efficacy and Safety Aliviador Compared to Gelol in Patients With Contusions, Sprains, Trauma and Muscle Injury.
A Phase 3 study testing Aliviador and Gelol in people with Contusions and Sprains, run by Laboratorio Brasileiro de Biologia at 3 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Contusions, Sprains, Trauma
- What is being tested?
- Aliviador and Gelol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesBrazil
- Study dates
- Jun 2010to Aug 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-650
Abel Pereira Junior, investigator, 55 11 49905244, abelpsjr@terra.com.br
Selma Squassoni, study coordinator, 55 11 49935459, selma_denis@yahoo.com.br
Clínica Perdizes
São Paulo, São Paulo, 05005-001
Gilberto de Castro Brandão, investigator, 55 11 3825666, gilbertobrandao@hotmail.com
S.C. Corinthians Paulista
São Paulo, São Paulo
Paulo de Faria, 55 11 20953000 ext. 3146, phfaria@uol.com.br
About this study
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.
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
- Being tested
- Aliviador, Gelol
- Keywords
- muscle injury
- Medical subject headings
- Contusions, Sprains and Strains, Wounds and Injuries, Myalgia, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AliviadorDrug
The study medication should be applied regimen of 8/8 hours over 2 days.
GelolDrug
The study medication should be applied regimen of 8/8 hours over 2 days.
| Study group | Role | What they receive |
|---|---|---|
| Aliviador | Experimental | Not described Receives: Drug: Aliviador |
| Gelol | Active comparator | Not described Receives: Drug: Gelol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two days
Secondary outcomes (1)
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.
Measured: two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2010 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContusionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratorio Brasileiro de Biologia
- Sponsor type
- University, hospital or other
- Investigators
- Abel Pereira Junior, investigator, Principal investigator, Faculdade de Medicina do ABCGilberto de Castro Brandão, investigator, Principal investigator, Clínica PerdizesPaulo Faria, investigator, Principal investigator, S.C. Corinthians Paulista
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097798
- Sponsor's protocol ID
- LBB-ALI-01/09
- Acronym
- LBB-ALI-01/09
- Status last verified
- Feb 2010
- First submitted
- 1 Apr 2010
- Last updated
- 16 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01097798
- Acronym / sponsor ID
- LBB-ALI-01/09 / LBB-ALI-01/09
- Conditions
- Contusions, Sprains, Trauma, Muscle Injury, Myalgia, Myofascial Pain
- Keywords
- muscle injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Laboratorio Brasileiro de BiologiaUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 2 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aliviador | Experimental | Drug: Aliviador |
| Gelol | Active comparator | Drug: Gelol |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AliviadorThe study medication should be applied regimen of 8/8 hours over 2 days. | Drug | Aliviador |
| GelolThe study medication should be applied regimen of 8/8 hours over 2 days. | Drug | Gelol |
Primary outcome
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.
1 secondary outcome
To evaluate the tolerability use Aliviador compared to Gelol.
Time frame: two days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abel Pereira Junior, investigator principal investigator
Faculdade de Medicina do ABC
Gilberto de Castro Brandão, investigator principal investigator
Clínica Perdizes
Paulo Faria, investigator principal investigator
S.C. Corinthians Paulista
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aliviador and Gelol in people with Contusions and Sprains, run by Laboratorio Brasileiro de Biologia at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abel Pereira Junior, investigator principal (55 11 49905244, abelpsjr@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy in reducing signs and symptoms Aliviador compared to Gelol. (time frame: two days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2010.