Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Randomized, controlled, double-blind, multi-center trial to evaluate the efficacy and safety of an Esflurbiprofen Topical System (EFTS) vs. placebo in the local symptomatic and short-term treatment of pain in ankle sprains.

This study aims to discover if a special pain-relief patch, called Esflurbiprofen Topical System (EFTS), is effective and safe for people with ankle sprains. Participants with a mild ankle sprain will be divided into different groups. Some will receive the EFTS patch, others a dummy patch with no medicine, and some may receive paracetamol. Researchers will carefully track their pain levels, ability to move, and any side effects over a short period. The main goal is to understand if the EFTS patch helps reduce pain more effectively and quickly than the other treatments, helping us find better ways to treat this common injury.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Teikoku Seiyaku Co. Ltd.

Enrolment target

110

Start

29 Oct 2024

Acute ankle sprains grade I

What is this study about?

When you sprain your ankle, it can be quite painful and make it hard to move around. Doctors are always looking for better ways to help people recover quickly and manage their pain. This particular study is designed to test a new type of treatment – a special patch called Esflurbiprofen Topical System (EFTS).

Imagine a patch you put on your skin, similar to a plaster, but it releases medicine to help with pain. This study wants to find out if this EFTS patch is good at easing the pain from a *mild* ankle sprain. They will compare it to two other things: a 'dummy' patch that looks exactly the same but doesn't have any medicine in it (this helps us know if the medicine itself is working, not just the act of putting on a patch), and also to paracetamol, a common painkiller.

The main aim is to see how much pain reduction people get with the EFTS patch compared to the dummy patch or paracetamol, especially during the first two days after their sprain. They'll also look at whether it helps people get back to their normal activities faster and if there are any side effects. All of this information helps doctors decide if this new patch could be a useful treatment option for future patients with ankle sprains.

Key takeaways

This study tests a new pain-relief patch for mild ankle sprains.
It compares the patch to a dummy patch and paracetamol.
Pain intensity and ability to move will be carefully tracked.
It's a 'blinded' study, so you won't know which treatment you're getting.
Participation involves clinic visits and lasts about one week.
The goal is to find better ways to treat ankle sprain pain.

Who may be eligible?

This study is looking for adult volunteers who have recently experienced a *mild* ankle sprain. This means your sprain is considered 'Grade I' by doctors, which is the least severe type.

To join, you need to be at least 18 years old. The study is open to both men and women.

There might be other health conditions or medications that would prevent you from taking part, but the study team will discuss all of these with you in detail to make sure it's safe for you.

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 at least 18 years old?
Have you recently sprained your ankle?
Has a doctor told you it's a 'Grade I' (mild) sprain?
Are you able to attend several clinic visits over about a week?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of several groups. This means you might receive the special pain-relief patch, a dummy patch with no medicine, or paracetamol – neither you nor the doctors will know which one you're getting, to keep the results fair. You'll need to apply the patch as instructed or take the paracetamol.

Throughout the study, you'll have several visits to the clinic. During these visits, the study team will measure your pain levels, often using a simple scale where you rate your pain. They will also check how well you can move your ankle and ask about any side effects you might be experiencing. They'll also check how well the patch sticks.

Your pain will be checked very closely over the first 48 hours, and then less often for up to a week. The study will also track how quickly your pain goes away and when you feel ready to get back to your usual activities. The total duration of active participation will be about one week, with assessments focusing on the initial recovery phase.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as receiving close medical attention for your ankle sprain and access to a new treatment that might help reduce your pain. However, there's also a chance you might receive a dummy treatment or a standard treatment that might not be as effective for you. Potential risks could include skin irritation from the patch or side effects from any medication, although these are carefully monitored. It's important to remember that participating is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future 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 an ankle sprain Grade I?

A Grade I ankle sprain is the mildest type, where the ankle ligaments are stretched but not torn, causing mild pain and swelling.

What is a 'dummy patch'?

A 'dummy patch' (or placebo) looks exactly like the treatment patch but doesn't contain any medicine. It helps researchers know if the medicine itself is causing the effect.

Will I know if I'm getting the real patch or the dummy patch?

No, neither you nor the study doctors will know which treatment you are receiving. This is called 'double-blind' and ensures the results are unbiased.

How long will I need to be in the study?

The main part of the study where your pain is closely monitored will be for about one week after your sprain.

Can I still take my regular painkillers?

The study will provide specific pain relief relevant to your study group. You will need to discuss any other medications, including regular painkillers, with the study team.