Musculoskeletal PainPhase 3PROGELNCT05013567
Efficacy and Safety Study of Ibuprofen Gel Compared to Placebo in the Treatment of Acute Musculoskeletal Pain
A Phase 3 study testing Ibuprofen gel in people with Musculoskeletal Pain and Acute Pain, run by Brainfarma Industria Química e Farmacêutica S/A.
Trial summary
Phase III clinical trial, multicentre of superiority, randomized, double-blind, parallel groups, placebo-controlled and use of ibuprofen gel in the treatment of acute pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Pain, Acute Pain, Stretch
- What is being tested?
- Ibuprofen gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Aug 2022to Jul 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have signed the informed consent form;
- Participants of both genders aged ≥ 18 years;
- Present acute musculoskeletal pain as a result of: ankle sprains, upper limb contusions, thigh muscle sprains, or torticollis;
- Present pain of moderate intensity by VAS scale (3 ≤ VAS ≤ 7);
- Pain onset time is less than 36 hours;
- Present intact skin at the trauma site;
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- Participants of both sexes with the potential to become pregnant must be truly abstinent or use a highly effective method of contraception throughout the period of 30 days before the administration of the drug until 30 days after the end of treatment;
- Agree to safety laboratory tests: pregnancy test, complete blood count, and biochemical profile;
- Be able to understand the nature and purpose of the trial, including the risks and adverse events.
Who cannot join
- Participants under the age of 18;
- Participants with musculoskeletal pain as a result of fractures or dislocations;
- Participants with mild pain (VAS < 3) at the time of selection;
- Participants with severe pain (VAS > 7) at the time of selection;
- Participants with pain onset time greater than 36 hours;
- Participants with a history of chronic pain and acute pain spikes;
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- Participants with loss of skin integrity at the trauma site;
- Have a known hypersensitivity reaction to the trial medication or chemically related compounds;
- Have a prior history of the following comorbidities: asthma or other allergic conditions, uncontrolled heart failure, chronic kidney disease, chronic liver disease, active peptic ulcer disease, or gastrointestinal bleeding;
- Suspect for COVID-19 according to the criteria defined by the World Health Organization;
- Regular use of analgesics, non-steroidal analgesics or anticoagulants;
- Use of oral or topical corticoids in the injured area;
- Being on medications that have relevant interactions with the trial drugs, such as non-steroidal anti-inflammatory drugs (NSAIDs), warfarin, lithium, methotrexate, acetylsalicylic acid, corticosteroids, oral hypoglycemic agents, beta blockers, angiotensin-converting enzyme inhibitors, antihypertensive agents, and diuretics such as furosemide or thiazide;
- Have had oral or topical analgesic treatment, including use of non-steroidal analgesics, within 72 hours prior to the screening visit;
- Participants using traditional Chinese or Japanese therapy (acupuncture);
- Abusive use of alcoholic beverages;
- Women who are pregnant, breastfeeding, planning to become pregnant, or who test positive for pregnancy during the trial period;
- Have participated in a clinical trial within the last 12 months;
- Have any condition that would preclude participation in the trial in the physician's judgment.
Trial locations and contacts
No sites are listed yet.
Cosmed Indústria de Cosméticos e Medicamentos S/A contact
About this study
Official title: Randomized, Double-Blind, Parallel, Phase III Superiority Clinical Trial to Evaluate the Efficacy and Safety of Ibuprofen Gel Compared With Placebo in the Treatment of Acute Musculoskeletal Pain
Phase III clinical trial, multicentre of superiority, randomized, double-blind, parallel groups, placebo-controlled and use of ibuprofen gel in the treatment of acute pain.
Read the detailed description
This study is designed for the relief of acute musculoskeletal pain, characterized by pain in muscles, ligaments, tendons, and nerves.
It is performed in participants of both sexes, over 18 years of age, who have pain of moderate intensity as a result of ankle sprains, upper limb contusions, thigh muscle strains, or torticollis.
The rationale for studying the topical use of ibuprofen is the possibility of an alternative treatment for musculoskeletal pain, avoiding systemic adverse events caused by oral administration.
- Conditions
- Musculoskeletal Pain, Acute Pain, Stretch, Sprains
- Being tested
- Ibuprofen gel, Placebo
- Keywords
- ibuprofen, ibuprofen gel, pain
- Medical subject headings
- Musculoskeletal Pain, Acute Pain, Sprains and Strains, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen gelDrug
Ibuprofen gel 5% topically four times a day
PlaceboOther
Placebo gel topically four times a day
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen gel 5% | Experimental | Not described Receives: Drug: Ibuprofen gel |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superiority of ibuprofen gel over placebo in the treatment of acute musculoskeletal pain.
The primary endpoint of the study is the proportion of participants achieving at least 50% pain reduction on day 5 of treatment by assessing pain intensity using the Visual Analog Scale (VAS), compared to baseline VAS. (Scale = 0 to 10; 0 = mild pain and 10 = severe pain)
Measured: 5 days of treatment
Secondary outcomes (7)
Pain relief with study medication on days 3, 5, and 7.
Pain relief by the adapted Pain Relief (PAR) Scale, with the 5 categories: 0 - no relief, 1- slight relief, 2 - moderate relief, 3 - considerable relief, and 4 - complete relief, on days 3, 5, and 7.
Measured: 3, 5 and 7 days of treatment
Interference of pain on physical activity on days 3, 5 and 7
Pain interference with physical activity by 4-point scale: 0 - no interference with physical activity; 1 - no restriction of physical activity, although some pain on movement; 2 - some restriction of physical activity, but not enough to prevent normal activity; 3 - unable to perform normal activities and with substantial limiting effects, on days 3, 5, and 7.
Measured: 3, 5 and 7 days of treatment
Time needed for pain improvement.
Time needed for pain improvement (reduction of at least 50% of pain on the VAS scale)
Measured: Through study completion, an average of 7 days
Obtain the overall assessment of effectiveness, performed by the participant at the end of the treatment.
Overall assessment of treatment by participant using 5-point scale: bad, fair, good, very good, and excellent.
Measured: Through study completion, an average of 7 days
Obtain the overall efficacy evaluation, performed by the investigator at the end of the treatment.
Overall assessment of treatment by physician using 5-point scale: bad, fair, good, very good, and excellent.
Measured: Through study completion, an average of 7 days
Number of participants using rescue medication.
Measured: Through study completion, an average of 7 days
Time to use of rescue medication.
Measured: Through study completion, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study startAug 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brainfarma Industria Química e Farmacêutica S/A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brainfarma Indústria Química Farmacêutica, Study director, Brainfarma Industria Química e Farmacêutica S/A
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013567
- Sponsor's protocol ID
- HYP 001-21
- Acronym
- PROGEL
- Status last verified
- Aug 2021
- First submitted
- 3 Aug 2021
- Last updated
- 21 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Parallel, Phase III Superiority Clinical Trial to Evaluate the Efficacy and Safety of Ibuprofen Gel Compared With Placebo in the Treatment of Acute Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT05013567
- Acronym / sponsor ID
- PROGEL / HYP 001-21
- Conditions
- Musculoskeletal Pain, Acute Pain, Stretch, Sprains
- Keywords
- ibuprofen, ibuprofen gel, pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Brainfarma Industria Química e Farmacêutica S/AIndustry (pharma, biotech, devices)
- Study start
- Aug 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 19 Aug 2021 (actual)
- 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.
Phase III clinical trial, multicentre of superiority, randomized, double-blind, parallel groups, placebo-controlled and use of ibuprofen gel in the treatment of acute pain.
Detailed description
This study is designed for the relief of acute musculoskeletal pain, characterized by pain in muscles, ligaments, tendons, and nerves.
It is performed in participants of both sexes, over 18 years of age, who have pain of moderate intensity as a result of ankle sprains, upper limb contusions, thigh muscle strains, or torticollis.
The rationale for studying the topical use of ibuprofen is the possibility of an alternative treatment for musculoskeletal pain, avoiding systemic adverse events caused by oral administration.
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 |
|---|---|---|
| Ibuprofen gel 5% | Experimental | Drug: Ibuprofen gel |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have signed the informed consent form;
- Participants of both genders aged ≥ 18 years;
- Present acute musculoskeletal pain as a result of: ankle sprains, upper limb contusions, thigh muscle sprains, or torticollis;
- Present pain of moderate intensity by VAS scale (3 ≤ VAS ≤ 7);
- Pain onset time is less than 36 hours;
Key exclusion criteria (19 listed)
- Participants under the age of 18;
- Participants with musculoskeletal pain as a result of fractures or dislocations;
- Participants with mild pain (VAS < 3) at the time of selection;
- Participants with severe pain (VAS > 7) at the time of selection;
- Participants with pain onset time greater than 36 hours;
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 |
|---|---|---|
| Ibuprofen gelIbuprofen gel 5% topically four times a day | Drug | Ibuprofen gel 5% |
| PlaceboPlacebo gel topically four times a day | Other | Placebo |
Primary outcome
Superiority of ibuprofen gel over placebo in the treatment of acute musculoskeletal pain.
Time frame: 5 days of treatment
The primary endpoint of the study is the proportion of participants achieving at least 50% pain reduction on day 5 of treatment by assessing pain intensity using the Visual Analog Scale (VAS), compared to baseline VAS. (Scale = 0 to 10; 0 = mild pain and 10 = severe pain)
7 secondary outcomes
Pain relief with study medication on days 3, 5, and 7.
Time frame: 3, 5 and 7 days of treatment
Interference of pain on physical activity on days 3, 5 and 7
Time frame: 3, 5 and 7 days of treatment
Time needed for pain improvement.
Time frame: Through study completion, an average of 7 days
Obtain the overall assessment of effectiveness, performed by the participant at the end of the treatment.
Time frame: Through study completion, an average of 7 days
Obtain the overall efficacy evaluation, performed by the investigator at the end of the treatment.
Time frame: Through study completion, an average of 7 days
Number of participants using rescue medication.
Time frame: Through study completion, an average of 7 days
Time to use of rescue medication.
Time frame: Through study completion, an average of 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
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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.
Cosmed Indústria de Cosméticos e Medicamentos S/A contact
Brainfarma Indústria Química Farmacêutica study director
Brainfarma Industria Química e Farmacêutica S/A
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ibuprofen gel in people with Musculoskeletal Pain and Acute Pain, run by Brainfarma Industria Química e Farmacêutica S/A.
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 9 inclusion and 19 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 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Cosmed Indústria de Cosméticos e Medicamentos S/A (5511 45072111, juliana.augusto@brainfarma.ind.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superiority of ibuprofen gel over placebo in the treatment of acute musculoskeletal pain. (time frame: 5 days of treatment). 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 21 Mar 2022.