Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

A Prospective Real-World Evidence Study Evaluating the Effects of Voltaren use on Mobility and Quality of Life

This research is investigating how much a pain-relief gel called Voltaren helps people with a common type of knee arthritis, known as mild osteoarthritis. The study aims to understand if using Voltaren helps individuals move more easily and improves their general well-being. Researchers will be carefully observing changes in how much physical activity people do, like walking or cycling, over a three-week period. They'll also check other things like how many steps they take, how many stairs they climb, and whether morning stiffness gets better. The goal is to see if Voltaren makes a noticeable difference to their daily life.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

Haleon CH S.a.r.l.

Enrolment target

165

Start

01 Jul 2024

Mild/non-serious osteoarthritis (OA) of the knee.

What is this study about?

This study is designed to understand how a pain-relieving gel, Voltaren, works for people who have mild osteoarthritis in their knee. Osteoarthritis is a common condition where the protective cartilage on the ends of your bones wears down over time, leading to pain, stiffness, and swelling. This research specifically focuses on how using Voltaren might help people move more easily and improve their overall daily life.

The main thing researchers want to find out is whether using Voltaren helps people do more moderate and vigorous physical activity – activities that get you moving, like taking a brisk walk or cycling. They will measure this over three weeks, looking at how much people's activity levels change from when they started the study.

Beyond just activity levels, the study will also look at other important details. This includes tracking how many steps people take each day, how many stairs they go up and down, and if they spend less time sitting. They'll also check if their way of walking improves and if morning stiffness becomes less of a problem. All this information will help us understand the full impact of Voltaren on people's mobility and how they feel day-to-day.

Key takeaways

The study investigates Voltaren gel for mild knee osteoarthritis.
It aims to see if movement and daily life improve over three weeks.
Participants will use Voltaren gel and have their activity tracked.
Both men and women aged 18 and over with mild knee OA can apply.
The study lasts for 3 weeks, with regular check-ups.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

If you are thinking about joining this study, you would need to be an adult, aged 18 or older. There is no upper age limit, so people of all adult ages are welcome to consider taking part.

The study is open to both men and women. The main health requirement is that you have mild knee osteoarthritis – this means your knee pain is not severe and your doctor has diagnosed you with this condition. You would need to be generally healthy apart from your knee osteoarthritis.

More specific details about who can and cannot join would be explained by the study team, for example, if you are taking certain other medicines or have other health conditions, you might not be able to participate. It's always best to discuss this fully with the study doctors.

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?
Have you been diagnosed with mild osteoarthritis in your knee?
Are you generally healthy, apart from your knee osteoarthritis?
Are you able to attend appointments and potentially wear an activity tracker for three weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be asked to use Voltaren gel on your affected knee. There are two different strengths of Voltaren gel being looked at in this study. You would use the gel as instructed by the study team. Over a period of three weeks, the research team would monitor your progress.

During these three weeks, you would likely be asked to keep track of your physical activity. This might involve wearing a device, like a special watch or tracker, which measures how much you move, how many steps you take, and how much time you spend sitting. You would also have check-ins with the study team at the end of the first, second, and third weeks to see how you are feeling and if your symptoms have changed. The total time you would be involved in the study is three weeks.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as receiving treatment for your knee pain and having your condition closely monitored by medical professionals. The study aims to see if Voltaren gel can help you move more easily and improve your daily life. As with any medication, there can be potential risks, such as local skin reactions to the gel, like redness or itching. The study doctors will carefully explain all known and potential side effects. Importantly, your participation is completely voluntary, and 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
Poland

Common questions

What is mild knee osteoarthritis?

It's a common condition where the cushioning in your knee joint wears down a bit, causing mild pain and stiffness, but it's not severe.

What is Voltaren gel?

Voltaren is a pain-relieving gel that you rub on your skin. It helps reduce pain and swelling, often used for joint and muscle aches.

How long will I need to be in the study?

The study lasts for three weeks in total, during which you will use the gel and have your activity monitored.

Will I know if I'm getting the active gel or a dummy gel?

This study is looking at two different strengths of Voltaren gel, not comparing it to a dummy gel. You will receive one of the active gels.

What does 'physical activity' mean in this study?

It refers to things like walking, cycling, or any activity that gets your heart rate up a bit, like brisk walking, not just gentle movement.