Muscular AtrophyPhase 3NCT01373697
Study to Assess the Efficacy and Safety of Ibuprofen 50 mg/g Gel Compared to Profenid 25mg/g Gel
A Phase 3 study testing Ibuprofen and Profenid in people with Muscular Atrophy and Sprains, run by Laboratório Teuto Brasileiro S/A at 1 site in Brazil.
Trial summary
The aim of this study is to determine that ibuprofen 50mg/g gel is effective and safety treating patients with muscle aches, joint pains or due to sprains, bruises, tendinitis or myofascial compared to Profenid 25mg/g gel. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Muscular Atrophy, Sprains, Tendonitis
- What is being tested?
- Ibuprofen and Profenid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2011to Aug 2011
- 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 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of both sexes, of any race, aged 12 years;
- Ability to read, understand and sign the Informed Consent in the case of minors monitoring and consent of a parent;
- Complaint of clinical muscle pain, joint pain caused by sprains, contusions, tendonitis, or myofascial;
- Score more than 4 VAS symptom reviewed: Pain;
- Patients able to understand and follow the protocol of the trial.
- Patients with or without ligament injury ligament injury partial and incomplete
Who cannot join
- Known hypersensitivity to components of the formula, both the medication and the comparative test;
- Hypersensitivity to acetylsalicylic acid;
- Hypersensitivity to ketoprofen, ibuprofen or other anti-inflammatory steroid;
- Hypersensitivity to acetaminophen;
- Skin changes in the pathological site of application, such as eczema or acne, or infected skin or wound;
- Pregnant or lactating women.
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- Patients who require surgery or immobilization;
- Patients with fractures or ligament rupture;
- Patients taking anticoagulants;
- Patients with decompensated concomitant systemic diseases, such as diabetes, congenital or acquired blood disorders, convulsive disorders, autoimmune diseases, renal failure, severe infections, hormonal disorders and pulmonary disorders;
- Use of NSAIDs, corticosteroids or venotherapics, threads or any other form of administration;
- History of alcoholism or substance abuse;
- Conditions in the opinion of the investigator make the patient unsuitable to participate in the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
ABC School of Medicine
São Paulo, 09060-650
Gilberto Brandão, investigator, (11) 3825-5666, gilbertobrandao@hotmail.com
About this study
Official title: Clinical Multicenter, Phase III, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Ibuprofen 50mg/g Gel in the Treatment of Patients With Muscle Pain, Joint, or Pain Caused by Sprains, Contusions, Tendinitis, or Myofascial Compared to Profenid ® 25mg/g. Gel
The aim of this study is to determine that ibuprofen 50mg/g gel is effective and safety treating patients with muscle aches, joint pains or due to sprains, bruises, tendinitis or myofascial compared to Profenid 25mg/g gel.
Read the detailed description
The main objective of this study is to evaluate the efficacy of ibuprofen 50 mg/g gel in the treatment of patients with muscle, joint pain caused by sprains, contusions, tendinitis, or myofascial compared to Profenid 25mg/g gel.
- Conditions
- Muscular Atrophy, Sprains, Tendonitis
- Being tested
- Ibuprofen, Profenid
- Keywords
- Ibuprofen, muscle pain, sprains, contusions, tendonitis
- Medical subject headings
- Muscular Atrophy, Sprains and Strains, Tendinopathy, Myalgia, Contusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Apply the gel at the site of pain or injury, massaging gently to promote penetration of 8 in 8 hours for 5 days. Leave the gel on the premises at least 4 hours before removal
ProfenidDrug
Apply the gel on the spot of pain or injury, massaging slightly to facilitate the penetration of 8 in 8 hours during 5 days. Leave the gel on the the site at least 4 hours before removal
| Study group | Role | What they receive |
|---|---|---|
| Profenid | Active comparator | Apply the gel on the spot of pain or injury, massaging slightly to facilitate the penetration of 8 in 8 hours during 5 days. Leave the gel on the the site at least 4 hours before removal Receives: Drug: Profenid |
| Ibuprofen | Active comparator | Apply the gel on the spot of pain or injury, massaging slightly to facilitate the penetration of 8 in 8 hours during 5 days. Leave the gel on the the site at least 4 hours before removal Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical study evaluating the efficacy and safety of Ibuprofen 50mg / g gel in the treatment of patients with muscle pain, joint, or pain caused by sprains, contusions, tendinitis, or myofascial compared to Profenid ® 25mg / g gel. "
To evaluate the efficacy of ibuprofen 50 mg / g gel in the treatment of patients with muscle aches, joint pains or due to sprains, bruises, tendinitis or myofascial compared with Profenid® Gel 25mg / g, will be used two methods. 1. the visual analog scale (VAS)and 2. investigator's opinion to measure before and after treatment comparing the decrease of the symptoms. The study will have 144 patients to be included with any sex or race, minimum age 12 years.
Measured: five days
Secondary outcomes (1)
Clinical study evaluating the tolerability of Ibuprofen 50mg / g gel in the treatment of patients with muscle pain, joint, or pain caused by sprains, contusions, tendinitis, or myofascial compared to Profenid ® 25mg / g gel. "
To evaluate the tolerability of ibuprofen 50 mg / g gel in the treatment of patients with muscle aches, joint pains or due to sprains, bruises, tendinitis or myofascial compared with Profenid ® Gel 25mg / g will be use a measure using Naranjo algorithm to determinate the causality of the events.
Measured: five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular AtrophyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratório Teuto Brasileiro S/A
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Abel Pereira, investigator, Principal investigator, ABC School Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373697
- Sponsor's protocol ID
- TEU-IBU- 01-10
- Status last verified
- Jun 2011
- First submitted
- 22 Mar 2011
- Last updated
- 15 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Multicenter, Phase III, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Ibuprofen 50mg/g Gel in the Treatment of Patients With Muscle Pain, Joint, or Pain Caused by Sprains, Contusions, Tendinitis, or Myofascial Compared to Profenid ® 25mg/g. Gel
- ClinicalTrials.gov ID
- NCT01373697
- Acronym / sponsor ID
- TEU-IBU- 01-10
- Conditions
- Muscular Atrophy, Sprains, Tendonitis
- Keywords
- Ibuprofen, muscle pain, sprains, contusions, tendonitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Laboratório Teuto Brasileiro S/AIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 15 Jun 2011 (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.
The aim of this study is to determine that ibuprofen 50mg/g gel is effective and safety treating patients with muscle aches, joint pains or due to sprains, bruises, tendinitis or myofascial compared to Profenid 25mg/g gel.
Detailed description
The main objective of this study is to evaluate the efficacy of ibuprofen 50 mg/g gel in the treatment of patients with muscle, joint pain caused by sprains, contusions, tendinitis, or myofascial compared to Profenid 25mg/g gel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Profenid | Active comparator | Drug: ProfenidApply the gel on the spot of pain or injury, massaging slightly to facilitate the penetration of 8 in 8 hours during 5 days. Leave the gel on the the site at least 4 hours before removal |
| Ibuprofen | Active comparator | Drug: IbuprofenApply the gel on the spot of pain or injury, massaging slightly to facilitate the penetration of 8 in 8 hours during 5 days. Leave the gel on the the site at least 4 hours before removal |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients of both sexes, of any race, aged 12 years;
- Ability to read, understand and sign the Informed Consent in the case of minors monitoring and consent of a parent;
- Complaint of clinical muscle pain, joint pain caused by sprains, contusions, tendonitis, or myofascial;
- Score more than 4 VAS symptom reviewed: Pain;
- Patients able to understand and follow the protocol of the trial.
Key exclusion criteria (13 listed)
- Known hypersensitivity to components of the formula, both the medication and the comparative test;
- Hypersensitivity to acetylsalicylic acid;
- Hypersensitivity to ketoprofen, ibuprofen or other anti-inflammatory steroid;
- Hypersensitivity to acetaminophen;
- Skin changes in the pathological site of application, such as eczema or acne, or infected skin or wound;
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 |
|---|---|---|
| IbuprofenApply the gel at the site of pain or injury, massaging gently to promote penetration of 8 in 8 hours for 5 days. Leave the gel on the premises at least 4 hours before removal | Drug | Ibuprofen |
| ProfenidApply the gel on the spot of pain or injury, massaging slightly to facilitate the penetration of 8 in 8 hours during 5 days. Leave the gel on the the site at least 4 hours before removal | Drug | Profenid |
Primary outcome
Clinical study evaluating the efficacy and safety of Ibuprofen 50mg / g gel in the treatment of patients with muscle pain, joint, or pain caused by sprains, contusions, tendinitis, or myofascial compared to Profenid ® 25mg / g gel. "
Time frame: five days
To evaluate the efficacy of ibuprofen 50 mg / g gel in the treatment of patients with muscle aches, joint pains or due to sprains, bruises, tendinitis or myofascial compared with Profenid® Gel 25mg / g, will be used two methods. 1. the visual analog scale (VAS)and 2. investigator's opinion to measure before and after treatment comparing the decrease of the symptoms. The study will have 144 patients to be included with any sex or race, minimum age 12 years.
1 secondary outcome
Clinical study evaluating the tolerability of Ibuprofen 50mg / g gel in the treatment of patients with muscle pain, joint, or pain caused by sprains, contusions, tendinitis, or myofascial compared to Profenid ® 25mg / g gel. "
Time frame: five days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2011.
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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, investigator principal investigator
ABC School Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ibuprofen and Profenid in people with Muscular Atrophy and Sprains, run by Laboratório Teuto Brasileiro S/A at 1 site 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 6 inclusion and 13 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 15 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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, researcher (11 55 4993-5459, abelpsjr@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical study evaluating the efficacy and safety of Ibuprofen 50mg / g gel in the treatment of patients with muscle pain, joint, or pain caused by sprains, contusions, tendinitis, or myofascial compared to Profenid ® 25mg / g gel. " (time frame: five 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 15 Jun 2011; AzTrials last refreshed its copy on 8 Nov 2026.