Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Trial to Evaluate the Efficacy and Safety of Once Daily Diclofenac Gel AMZ001 3.06% in the Treatment of Pain and Symptoms of Knee Osteoarthritis

This research study is looking at a new gel called AMZ001, designed to help with pain and other symptoms caused by knee osteoarthritis. Researchers want to find out if this gel, used once a day, is effective and safe compared to a placebo (a gel with no active medicine). They are particularly interested in how much pain relief people get within the first two weeks of using the gel. This is an important step, known as a Phase III trial, to determine if the AMZ001 gel could eventually be an option for people living with knee osteoarthritis.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Amzell B.V.

Enrolment target

206

Start

29 Apr 2025

Knee Osteoarthritis

What is this study about?

This study aims to discover if a new gel, AMZ001, can effectively reduce pain and improve symptoms for people with knee osteoarthritis. Osteoarthritis is a common condition where the cartilage in your joints wears down, leading to pain, stiffness, and sometimes swelling, especially in the knees. Currently, many treatments are available, but doctors are always looking for new and better ways to manage the condition.

In this trial, some participants will receive the AMZ001 gel, while others will be given a 'dummy' gel (called a placebo). Neither the participants nor the doctors will know who is getting which gel. This helps to ensure the results are as fair and accurate as possible, so we can clearly see if any improvements are due to the AMZ001 gel itself.

The main thing researchers will be observing is how much a participant's knee pain changes after two weeks of using the gel. They'll also be looking at many other aspects, like pain relief over different time periods, how well people sleep, their overall quality of life, and how their knee function improves over several weeks. This comprehensive approach helps to build a full picture of the gel's potential benefits and any side effects.

Key takeaways

This study is testing a new gel (AMZ001) for knee osteoarthritis pain.
It aims to see if the gel is safe and effective compared to a 'dummy' gel.
The main focus is on how much pain relief participants experience.
Both men and women aged 18 and over with knee osteoarthritis can be considered.
Participation involves using the gel daily and attending clinic visits for assessments.

Who may be eligible?

This study is looking for adults aged 18 and older who have been diagnosed with knee osteoarthritis. This means your doctor has confirmed you have this condition affecting one or both of your knees.

Both men and women are welcome to take part in this study. There isn't an upper age limit mentioned, so older adults with knee osteoarthritis can also be considered.

The research team will have a more detailed list of who can and cannot join the study to make sure it's safe and that the results are clear. Your doctor can help determine if you meet all the necessary criteria.

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 knee osteoarthritis?
Are you willing to apply a gel to your knee once a day?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit to check if you meet all the requirements. If you're eligible, you would then be given either the AMZ001 gel or a placebo gel to apply to your knee once a day. You would use this gel for a period of several weeks.

Throughout the study, you would have several visits to the clinic where doctors and nurses would perform various assessments. These assessments would involve answering questionnaires about your pain levels and daily activities, particularly focusing on your knee. They would also monitor your overall health and check for any side effects. You might be asked to keep a diary of your pain and medication use at home. The exact number of visits, tests, and the total duration of your participation would be explained in full by the study team.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available and contributing to medical knowledge that could help others. However, there are also potential risks, including side effects from the study gel, which might be mild or, in rare cases, more serious. The gel might also not work for you, or it might not work better than existing treatments. All potential risks and benefits will be fully explained before you decide to join. Remember, you can choose to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (3)

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

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Unverified
Denmark
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Unverified
Czechia
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Unverified
Poland

Common questions

What is knee osteoarthritis?

It's a common condition where the cushion (cartilage) in your knee joint wears down over time, causing pain, stiffness, and sometimes swelling.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It helps researchers see if the real medicine is truly effective.

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

No, this is a 'blinded' study, meaning neither you nor your study doctor will know which treatment you are receiving until the study is over.

How long will the study last for me?

The full duration of your participation, including follow-up, will be clearly explained by the study team before you join.

What does a 'Phase III' trial mean?

This is a key stage where the new treatment has already shown promise in earlier studies, and now researchers want to confirm its effectiveness and safety in a larger group of people.