A randomized, two-arm, placebo-controlled, participant and investigator-blinded study investigating the efficacy, safety and tolerability of DFV890 in patients with symptomatic knee osteoarthritis
This research study is testing a new medication called DFV890 for adults suffering from knee osteoarthritis. The study aims to find out if DFV890 can reduce pain and improve knee function, and if it has any side effects. Participants will receive either DFV890 or a placebo, which looks like the real medicine but contains no active drug. This helps researchers understand if any improvements are genuinely due to DFV890 or other factors. Doctors and participants won’t know who is getting which treatment. The main goal is to see how much knee pain changes over 12 weeks, but other aspects like swelling, daily activities, and quality of life will also be tracked.
At a glance
What is this study about?
This study is all about finding new ways to help people living with knee osteoarthritis. Osteoarthritis is a common condition where the cartilage that cushions your joints wears down, leading to pain, stiffness, and sometimes swelling. It can make everyday activities quite difficult.
Researchers are testing a new medicine called DFV890. This study is designed to see if DFV890 can make a real difference for people with painful knee osteoarthritis. They want to find out how well it works to reduce pain and improve how the knee functions, and just as importantly, they want to understand if it's safe and doesn't cause too many unwanted side effects.
To get clear answers, some participants will receive the new medicine, while others will get a 'placebo'. A placebo looks exactly like the real medicine but has no active ingredients. This is a standard and important part of medical research to ensure that any benefits seen are truly from the new medicine and not just because people expect to feel better. Neither you nor the study doctors will know who is getting which treatment until the study is over.
Key takeaways
- Tests new drug DFV890 for knee osteoarthritis pain.
- Compares DFV890 to a dummy treatment (placebo).
- Aims to check if DFV890 reduces pain and is safe.
- Participants will have regular check-ups, blood tests, and scans.
- Study lasts for 12 weeks and involves adults over 18.
Who may be eligible?
This study is looking for adults who are 18 years old or older. Both men and women are welcome to take part in this research.
To be eligible, you must have been diagnosed with knee osteoarthritis and be experiencing symptoms, particularly pain. The study will have specific health requirements to make sure it's safe for you to participate and that the study results are clear.
There will be certain medical conditions or medications that might mean you can't join the study. These rules are in place to protect your health and ensure the study is conducted properly. If you're interested, the study team will go through these details with you to see if you're a good fit.
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 currently experiencing pain from your knee osteoarthritis?
- Are you able to attend regular clinic visits?
- Are you willing to potentially receive either the new medicine or a dummy treatment?
What does participation involve?
If you decide to take part in this study, you will be given either the new study medicine (DFV890) or a dummy treatment (placebo) for a period of time. You will also use commonly available painkillers like paracetamol or a combination of paracetamol and codeine when needed for pain relief, but these will be provided in a controlled way.
Throughout the study, you will have several appointments at the clinic. These visits will involve various checks to see how you are doing, including physical examinations, blood tests, urine tests, and heart monitoring (ECGs). You'll be asked to fill out questionnaires about your pain and how your knee affects your daily life. They will also use special scans (like MRI) to look at your knee joint for any changes in swelling.
Researchers will collect blood samples at different times to measure how much of the study medicine is in your body. The study will last for 12 weeks, with follow-up appointments and checks spread out over that period. The total time you'll be involved in the study will be clearly explained.
Potential risks and benefits
Locations (5)
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedHungary
- —UnverifiedCzechia
- —UnverifiedRomania
Common questions
What is knee osteoarthritis?
It's a condition where the protective cartilage in your knee joint wears down, leading to pain, stiffness, and sometimes swelling.
What is DFV890?
DFV890 is a new medicine being tested to see if it can help reduce pain and improve function for people with knee osteoarthritis.
What is a 'placebo'?
A placebo is a dummy treatment that looks like the real medicine but contains no active drug. It helps researchers compare the new medicine's effects accurately.
Will I know if I'm getting the real medicine or the placebo?
No, both you and the study doctors won't know which treatment you're receiving until the study is over. This is to ensure fair and accurate results.
How long will the study last?
The main treatment period for the study is 12 weeks, with various check-ups spread out during that time.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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