Ongoing, recruitingTherapeutic use (Phase IV)Interventional

The effects of 2-week long treatment with naproxen sodium (Nalgesin® Forte) on synovial fluid cytokine and naproxen concentration and clinical outcomes in patients with knee osteoarthritis – ZOOM-IN: A randomized, double-blind, placebo-controlled, parallel, multicenter clinical trial

This research trial, called ZOOM-IN, is investigating how a common painkiller, naproxen (known as Nalgesin Forte), works for people with knee osteoarthritis. For two weeks, participants will either receive naproxen, a paracetamol, or a dummy pill (placebo). The main aim is to see if naproxen reduces inflammation in the knee joint more than the placebo. They'll do this by measuring specific chemicals related to inflammation in the joint fluid. Researchers will also look at whether naproxen helps with pain, stiffness, and overall knee function. This is a Phase IV trial, meaning the medicine is already approved, and researchers are gathering more information about its effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

KRKA tovarna zdravil d.d. Novo mesto

Enrolment target

Start

21 Oct 2024

Knee osteoarthritis

What is this study about?

This study, called ZOOM-IN, is a research project looking into how a common pain relief medicine called naproxen, sold as Nalgesin Forte, affects people with knee osteoarthritis. Osteoarthritis is a condition where the cartilage that cushions your joints wears away, leading to pain, stiffness, and swelling. Doctors already prescribe naproxen for pain relief, but this study wants to understand more about *how* it works in the knee joint itself.

For two weeks, some participants will take naproxen, others will take paracetamol, and some will take a 'dummy' pill (called a placebo) that looks just like the real medicine but contains no active ingredients. This helps researchers compare the effects of the actual medications. They will be measuring specific substances in the fluid around the knee joint that are linked to inflammation. They also want to see if naproxen helps reduce pain, improve movement, and make daily activities easier for people with knee osteoarthritis.

By carefully comparing the groups, the researchers hope to get a clearer picture of whether naproxen directly reduces inflammation within the knee joint and how this might link to improvements in people's symptoms. This kind of research helps doctors understand existing treatments better and can lead to more effective ways to manage knee osteoarthritis in the future.

Key takeaways

The study explores how naproxen affects knee osteoarthritis.
It compares naproxen to paracetamol and a dummy pill (placebo) over two weeks.
Researchers will check inflammation in knee fluid and measure changes in pain and movement.
This is a Phase IV trial, meaning naproxen is already approved for use.
Participation involves taking medication, clinic visits, and providing knee fluid samples.

Who may be eligible?

This study is for adults aged 18 and over, of any gender. You would be considered if you have been diagnosed with knee osteoarthritis.

More detailed checks would be done by the study team to make sure it's safe and appropriate for you to take part. For example, they would need to ensure you don't have certain other health conditions that could affect the study results or your safety.

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 diagnosis of knee osteoarthritis?
Are you comfortable with attending clinic visits?
Are you comfortable with the idea of providing fluid samples from your knee joint?
Are you able to take oral medication regularly for two weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to one of three groups: one taking naproxen, one taking paracetamol, or one taking a dummy pill (placebo). You wouldn't know which group you are in, and neither would your study doctor. You would take the assigned medication for two weeks.

Throughout the study, you'd have regular visits to the clinic. These visits would involve health checks, answering questions about your pain and knee function, and providing samples of fluid from your knee joint. There would also be follow-up appointments after you finish taking the medication to see how you are doing. The total duration of your involvement, including follow-up, would be communicated clearly by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might not directly benefit from this study, but your involvement could help researchers better understand knee osteoarthritis and lead to improved treatments for others in the future. Potential risks might include side effects from the medication, which the study team would explain thoroughly, or discomfort from procedures like providing joint fluid samples. You are free to withdraw from the study at any time, for any reason, without it affecting your usual 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 knee osteoarthritis?

Knee osteoarthritis is a common condition where the protective cartilage in your knee joint wears down, leading to pain, stiffness, and swelling.

What is naproxen (Nalgesin Forte)?

Naproxen is a type of pain relief medicine often used to reduce pain and inflammation in conditions like arthritis.

What is a 'placebo'?

A placebo is an inactive pill that looks just like the study medication but doesn't contain any active ingredients. It helps researchers compare the true effects of the actual medicine.

Why would I have fluid taken from my knee?

Researchers take samples of fluid from your knee to measure specific chemicals linked to inflammation, helping them understand how the medication affects your joint from the inside.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know which treatment you are receiving until after the study is complete. This helps to make the results as accurate as possible.