Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

An open label, multi-centric trial to assess the safety and efficacy of an Esflurbiprofen Topical System (EFTS) in the local symptomatic and short-term treatment of pain in contusions.

This study is looking at a new type of sticky patch called an Esflurbiprofen Topical System (EFTS). It's designed to help with pain and bruising (contusions) in your arms or legs. We want to find out how safe and effective this patch is when used for short periods. We'll be comparing it to paracetamol, a common pain reliever. The study will involve adults aged 18 and over and focuses on how well the patch eases pain, how quickly it works, and if there are any side effects. Your feedback on your pain levels and how the patch feels and sticks will be important.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Teikoku Seiyaku Co. Ltd.

Enrolment target

219

Start

07 Oct 2024

acute contusion of the upper or lower limbs

What is this study about?

Imagine you’ve had a bump or a fall and have a painful bruise on your arm or leg. This study is testing a new way to help ease that pain. It's called an Esflurbiprofen Topical System, which is basically a special sticky patch that delivers medicine directly to where it hurts. Researchers want to see if this patch is a good option for treating the pain from these kinds of injuries in the short term.

The main goal of the study is to check how safe this patch is and if it causes any unwanted effects, often called side effects. But we also want to see how well it actually works to relieve pain compared to taking paracetamol, which many people use for mild to moderate pain. We'll be looking at things like how quickly the pain gets better, how much it reduces, and if the bruise itself starts to heal faster.

This kind of study falls into a stage called 'Phase III'. This means that the treatment has already been tested in smaller groups, and now we're looking at a larger group of people to confirm its safety and effectiveness. The results from this study will help doctors and patients understand if this new patch could be a useful treatment for everyday bumps and bruises.

Key takeaways

This study evaluates a new pain-relief patch for bruises.
It compares the patch to paracetamol for short-term pain treatment.
The study assesses both safety (side effects) and effectiveness (pain relief).
It's open to adults aged 18 and over with recent arm or leg bruises.
Participation involves regular pain tracking and clinic visits over about a week.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. Both men and women can take part.

You would be considered for this study if you have recently had a new bruise (contusion) on your arm or leg that is causing you pain. This bruise should be new and not from an ongoing or long-term problem.

There will be other specific health requirements for joining, which the study team will discuss with you. These are put in place to make sure the study is safe for everyone involved and that we get clear results.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a new bruise on your arm or leg?
Is your bruise causing you pain?
Are you able to attend clinic visits over about a week?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be given either the special sticky patch (EFTS) or paracetamol to help with your pain. You’ll be asked to keep track of your pain levels regularly, often by rating it on a scale, and to note down how you’re feeling. This will include how well the treatment is working and if you notice any side effects.

You'll also have several visits to the clinic over a period of about a week. During these visits, the study team will check on your bruise, how it's healing, and how well the patch is sticking if you're using it. They will also ask about any other medicines you might be taking and if you've needed extra pain relief. The total time you'd be involved in the study, from your first visit to your last follow-up, would be short-term, likely around 7 days.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a new treatment for your pain and bruise, which might work better for you than existing options. You will also be closely monitored by medical professionals. However, there are also potential risks; you might experience side effects from the sticky patch or paracetamol, or the treatment might not relieve your pain. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is a 'contusion'?

A contusion is simply another name for a bruise, usually caused by a knock or impact.

What is an 'Esflurbiprofen Topical System'?

It's a special sticky patch (like a plaster) that contains medicine. 'Topical' means it's applied to the skin, and 'Esflurbiprofen' is the name of the pain-relieving medicine in it.

Will I know if I'm getting the patch or paracetamol?

In some studies, participants know which treatment they are receiving. The study team will explain if this is the case for this particular trial.

How long will I be in the study?

The study focuses on short-term treatment, so your active participation and follow-up would likely be for about a week.

Are there any costs for me to participate?

Clinical trials generally do not charge participants. Any travel expenses might be covered, but you should always confirm this with the study team.