Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A placebo-controlled, double-blinded, randomized, dose-finding trial using a combination of apocynin and paeonol (APPA) for the treatment of knee osteoarthritis

This research is looking into a new treatment called APPA for people with knee osteoarthritis. Researchers want to find out if this combination of medicines can help reduce the pain in the knee more effectively than a placebo (a dummy drug with no active ingredients) or a commonly used painkiller like Panodil. It's a Phase II study, meaning it's still in the early stages of testing, focusing on finding the right dose and checking for safety. The main way they'll measure success is by tracking how much knee pain improves after 12 weeks, using a special questionnaire. They'll also look at other things like how well people can move, their stiffness, overall quality of life, and any side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Akl Research & Development Limited

Enrolment target

170

Start

30 Apr 2024

Knee osteoarthritis

What is this study about?

This study is called a 'clinical trial' and its main goal is to test a new combination medicine, or 'intervention', for knee osteoarthritis. This new medicine is made up of two ingredients called apocynin and paeonol, and the combination is referred to as APPA. Osteoarthritis in the knee is a common condition where the cartilage, which is the cushion between your bones, wears away, leading to pain, stiffness, and difficulty moving. The researchers are hoping to find out if APPA can effectively reduce this pain and improve how people feel.

To make sure the results are fair and accurate, some people in the study will receive APPA, while others will get a 'placebo' (a tablet that looks the same but contains no active medicine). Another group might receive a standard painkiller like Panodil. This helps the researchers compare the new treatment to both no treatment and an existing treatment. It's also a 'double-blinded' study, meaning neither you nor your doctor will know which treatment you are receiving, which prevents anyone's expectations from affecting the results.

The main thing the researchers are looking at is how much your knee pain changes over 12 weeks. They will use a specific questionnaire to measure this. They will also look at other important things like how easily you can move, how stiff your knee feels, your general quality of life, and whether you experience any side effects. This trial is in 'Phase II', which means it's an early-stage study designed to understand the best dose of the medicine and to make sure it's safe before moving on to larger studies.

Key takeaways

This study is testing a new combined medicine (APPA) for knee pain from osteoarthritis.
It aims to see if APPA is better than a dummy treatment or a common painkiller.
The main goal is to measure how much knee pain improves over 12 weeks.
It's a 'double-blinded' and 'placebo-controlled' study for fair results.
Participants will have regular check-ups and assessments during the 12-week period.
You can withdraw from the study at any time without affecting your usual care.

Who may be eligible?

To be able to take part in this study, you must be an adult aged 18 or older. There is no upper age limit, so people of all adult ages are welcome to consider participating.

The study is open to both men and women. The specific medical requirements would be that you have been diagnosed with knee osteoarthritis. Other things, like your general health and any other medicines you take, would also be checked to make sure it's safe for you to take part.

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 able to attend regular clinic visits for about 12 weeks?
Are you comfortable with the possibility of receiving a placebo instead of active medication?

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 do, you would then be randomly assigned to one of the treatment groups: either APPA, a placebo (a dummy pill), or Panodil. You would take the assigned medication for 12 weeks.

Throughout these 12 weeks, you would have several visits to the study clinic. During these visits, the research team would ask you questions about your pain, stiffness, and how well you can do daily activities. They would also perform physical examinations, collect blood and urine samples, check your vital signs (like blood pressure and heart rate), and possibly do ECGs (tests of your heart electrical activity). You might also be asked to keep a daily diary of your pain and any other medications you take. The total duration of your active participation, including follow-up, would be around 12 weeks.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to a new treatment before it's widely available, and close monitoring of your health by medical professionals. However, there are also potential risks, including side effects from the medication, which could be mild or more serious, and the possibility that the treatment might not improve your condition. You also might receive a placebo, which means you won't get any active medication during the study. 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
Denmark

Common questions

What is knee osteoarthritis?

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

What is a placebo?

A placebo is a substance that looks exactly like the real medicine but does not contain any active drug. It's used in studies to see if the new medicine works better than no treatment at all.

Why is this study 'double-blinded'?

Being 'double-blinded' means neither you nor the doctors know if you're getting the active medicine or the placebo. This helps prevent anyone's expectations from influencing the study results.

What is APPA?

APPA is a new investigational medicine that combines two ingredients, apocynin and paeonol. This study is testing if this combination can help with knee pain from osteoarthritis.

How long will I be in the study?

If you take part, you would be actively involved in the study by taking medication and attending clinic visits for about 12 weeks.