ClinicalTrials.gg
Status unknownNCT01097798LBB-ALI-01/09Updated Apr 16, 2010

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

A Phase 3 interventional study of Aliviador and Gelol in Contusions, Sprains and Trauma, sponsored by Laboratorio Brasileiro de Biologia. Status unknown at 3 sites in Brazil. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2010-04-16.

Sponsored by Laboratorio Brasileiro de Biologia · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2010), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • muscle injury
03

In context

Contusions

43 studies on the registry are indexed under Contusions; 8 are open to participants now.

This study's planned enrollment of 120 is above the median of 90 across 31 interventional studies indexed under Contusions.

Browse Contusions studies →

Lead sponsor

This is the only study on the registry with Laboratorio Brasileiro de Biologia as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Known 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, diseases, renal failure, severe infections, hormonal disorders and pulmonary disorders.
  • History of alcoholism or illicit drug use;
  • Use of NSAIDs, 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Aliviador

    Drug: Aliviador

  • Active comparator
    Gelol

    Drug: Gelol

Interventions

  • DrugAliviador

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

  • DrugGelol

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

06

What researchers measure

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.

    Time frame: 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.

    Time frame: two days

07

Study locations

3 sites
  • Faculdade de Medicina do ABC
    Santo André, São Paulo 09060-650, Brazil
  • Clínica Perdizes
    São Paulo, 05005-001, Brazil
  • S.C. Corinthians Paulista
    São Paulo, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01097798
Lead sponsor
Laboratorio Brasileiro de Biologia
First posted
Apr 2, 2010
Start date
Jun 2010
Primary completion
Aug 2010 (estimated)
Completion
Aug 2010 (estimated)
Last update
Apr 16, 2010

Study contacts

Abel Pereira Junior, investigator principal
Contact
abelpsjr@terra.com.br
55 11 49905244
Selma Squassoni, study coordinator
Contact
selma_denis@yahoo.com.br
55 11 49935459
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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.

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