A randomized, multi-centre, double-blind, phase II clinical trial of dose finding of Montelukast in patients with erosive osteoarthritis of the hands. HOME study.
This research, called the HOME study, is looking into whether a medication called Montelukast can relieve pain for people who have erosive osteoarthritis in their hands. Participants will be randomly assigned to receive one of several different doses of Montelukast (5mg, 10mg, 15mg, or 30mg) or a placebo (a dummy pill with no active medicine). No one, including the doctors, will know who is taking which treatment. The main goal is to compare how much pain relief patients experience after 8 weeks of treatment using a special pain scale. The study will also look at other things like stiffness, hand function, and overall quality of life. This is a Phase II study, meaning it's exploring if the medicine works and to find the best dose.
At a glance
What is this study about?
This study, called the HOME study, is exploring a new way to help people with a condition called erosive osteoarthritis in their hands. This type of arthritis can cause a lot of pain and damage in the small joints of the hands. Researchers are investigating a medicine called Montelukast, which is already used for other health problems, to see if it can reduce this hand pain.
Participants in the study will receive either different doses of Montelukast or a placebo. A placebo is a dummy pill that looks just like the real medicine but contains no active ingredients. This helps researchers fairly compare the effects of Montelukast. The study is "double-blind," meaning neither you nor your study doctor will know whether you are taking Montelukast or the placebo. This helps ensure the study results are as unbiased as possible.
The main aim of the study is to see how much pain is reduced after 8 weeks of treatment compared to the start of the study, using a simple pain scale. The researchers will also be looking at other important aspects like how stiff your hands feel, how well you can use your hands, your overall quality of life, and whether your sleep is affected by pain. They will also carefully check for any side effects to make sure the treatment is safe.
Key takeaways
- Tests a medicine called Montelukast for hand pain due to erosive osteoarthritis.
- Compares different doses of Montelukast against a dummy pill (placebo).
- Study lasts 8 weeks with regular check-ups and assessments.
- Aims to find out if Montelukast reduces pain and improves hand function.
- Your identity and treatment group will be kept secret during the study.
- Your participation helps improve understanding of this condition.
Who may be eligible?
To join this study, you must be an adult aged 18 or older. Both men and women are welcome to take part.
The study is specifically for people who have been diagnosed with erosive osteoarthritis in their hands. This means the researchers are looking for individuals whose joints in their hands show signs of this condition.
There might be other specific health requirements or conditions that would prevent you from joining, such as other serious medical issues or taking certain medications. These will be discussed with you in detail by the study team to ensure the study is safe and appropriate for you.
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 erosive osteoarthritis in your hands?
- Are you willing to potentially take a placebo?
- Can you commit to regular clinic visits for 8 weeks?
What does participation involve?
If you decide to take part, you'll be assigned by chance to one of five groups: four groups will receive different doses of Montelukast (5mg, 10mg, 15mg, or 30mg), and one group will receive a placebo (dummy pill). You won't know which one you're taking, nor will your study doctor.
Over the course of 8 weeks, you will take the study medication daily. You'll have several visits to the clinic during this time. These visits will involve answering questions about your pain, stiffness, and hand function, and possibly undergoing some simple physical checks, like measuring your hand grip. They will also check your vital signs (such as temperature and blood pressure) and take blood samples to monitor your health and safety. Before starting and at the end of the 8 weeks, comprehensive checks will be done. After the 8-week treatment period, there will be follow-up checks to see how you are doing.
Potential risks and benefits
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Common questions
What is erosive osteoarthritis of the hands?
It's a type of arthritis that causes pain, swelling, and sometimes damage (erosions) in the small joints of your hands.
What is Montelukast?
Montelukast is a medicine already used for conditions like asthma and allergies. This study is exploring if it can also help with hand pain from arthritis.
What is a placebo?
A placebo is a 'dummy' pill that looks like the real medicine but doesn't contain any active drug. It helps researchers compare the true effects of the actual medicine.
How long will the treatment last?
The active treatment period with the study medication will last for 8 weeks.
Will I know if I'm getting the real medicine?
No, this is a 'double-blind' study, meaning neither you nor your doctor will know if you're receiving Montelukast or the placebo until after the study is over.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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