Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Efficacy and tolerability of ODM-111 in chronic pain due to osteoarthritis of the knee

This study is for adults who have ongoing knee pain because of osteoarthritis. Doctors want to find out if a new medicine, called ODM-111, can effectively reduce this pain. They'll compare it to a dummy pill (placebo) which has no active medicine, and also to a standard painkiller called Para-Tabs 500 mg. The main thing they'll be checking is how much your pain changes during the first six weeks of taking the medicine. This is an early-stage study (Phase II), meaning it's one of the first times this new medicine is being tested in a larger group of people to see if it works and is safe.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Orion Corporation

Enrolment target

234

Start

16 Oct 2024

Chronic Pain due to Ostheoarthritis of the knee

What is this study about?

This research study is focused on helping people who experience persistent knee pain due to a common condition called osteoarthritis. Osteoarthritis happens when the protective cartilage at the ends of your bones wears down over time, leading to pain, stiffness, and swelling.

The study aims to investigate a new medication, known as ODM-111, to see if it can effectively ease this pain. Researchers want to understand if ODM-111 is better at reducing pain than a 'dummy' pill (called a placebo), which looks the same but contains no active medicine. They will also compare it to a commonly used painkiller, Para-Tabs 500 mg, to see how it measures up against existing treatments.

This is an early-stage study, known as Phase II. This means it's one of the first times this new medicine is being tested in a larger group of people. The main goal is to find out if ODM-111 works and if it's safe enough to be studied further, potentially helping many more people in the future who live with chronic knee pain.

Key takeaways

Study for adults with ongoing knee pain from osteoarthritis.
Investigating a new medicine called ODM-111.
Compares ODM-111 to a dummy pill and a common painkiller.
Main goal is to see how much pain changes over six weeks.
This is an early-stage study (Phase II) to check effectiveness and safety.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or older. There is no upper age limit, so people of all adult ages can potentially join.

Both men and women are welcome to take part in this research. The study is open to everyone regardless of their gender.

Beyond age and gender, specific medical details about your knee pain and overall health will be checked by the study doctors to make sure this study is right for you and that you meet all the necessary requirements. This ensures the safety of participants and the accuracy of the study results.

Quick self-check

Are you 18 years old or older?
Do you have ongoing knee pain caused by osteoarthritis?
Are you male or female?
Are you able to attend regular appointments for about six weeks?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you will be given a medicine – either ODM-111, a dummy pill (placebo), or Para-Tabs 500 mg. You won't know which one you're receiving. You will take this medicine regularly as instructed. Over a period of six weeks, you will have regular appointments with the study team. During these visits, the doctors will check your general health, assess your knee pain using questionnaires, and ask about any side effects you might be experiencing. They will specifically track how your pain changes from the beginning of the study to the end of the six-week treatment period. The total duration of your active participation, including assessments and medication, will be around six weeks.

Potential risks and benefits

Taking part in this study might offer you a chance to try a new medicine that could help relieve your knee pain, potentially improving your daily life. However, there's no guarantee the new medicine will work for you, and like all medicines, ODM-111 could have side effects, which the study team will monitor closely. You will be told about any known risks before you agree to join. Remember, 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 usual medical care.

Locations (5)

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Czechia
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Poland
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Spain
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Germany
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Denmark

Common questions

What is osteoarthritis of the knee?

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

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredients. It helps researchers see if the real medicine is truly effective or if improvements are due to other factors.

Will I know which medicine I'm getting?

No, in this type of study, participants usually don't know whether they are receiving the new medicine, placebo, or the comparator painkiller until after the study is complete. This helps keep the results unbiased.

How long will I be in the study?

Your active involvement with taking the medicine and having check-ups for your pain will last about six weeks.

What does a Phase II study mean?

It means this is an early stage where a new medicine is tested in a larger group of people to see if it works and is safe, before potentially moving to bigger studies.