Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

A 2-stage, Adaptive, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Evaluate Dose and Treatment Effect of Pentosan Polysulfate Sodium Compared with Placebo in Participants with Knee Osteoarthritis Pain

This study is looking into a new medicine named pentosan polysulfate sodium to treat pain caused by knee osteoarthritis. Researchers will compare it to a dummy medicine (placebo) to see if it can effectively reduce knee pain and improve movement. The study is designed in two main parts, combining early-stage testing with later-stage testing. Participants won't know if they are receiving the new medicine or the placebo, and neither will their doctors. The main goal is to check how much improvement there is in knee pain after 56 days compared to the start, and also to see how much better daily knee function becomes. This research aims to find better ways to manage the discomfort and movement problems associated with knee osteoarthritis.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Paradigm Biopharmaceuticals (USA) Inc.

Enrolment target

Start

23 Feb 2023

Knee osteoarthritis pain

What is this study about?

This research study is about finding better ways to help people with pain in their knees due to osteoarthritis. Osteoarthritis is a common condition where the cartilage that cushions your joints wears down, leading to pain, stiffness, and difficulty moving.

The study is testing a new medicine called pentosan polysulfate sodium. They want to check if this medicine can reduce knee pain and improve how well people can use their knee, compared to a placebo. A placebo is a dummy medicine that looks just like the real medicine but contains no active ingredients. This helps researchers understand if the new medicine is truly effective or if any improvements are due to other factors.

This study is happening in different stages, combining both early and later testing. Researchers will be carefully looking at changes in knee pain and how well your knee works after 56 days. They will use a special questionnaire (called WOMAC) to measure these changes from when you start the study.

Key takeaways

The study is testing a new medicine for knee osteoarthritis pain.
It compares the new medicine to a dummy pill (placebo).
It aims to reduce pain and improve knee movement.
Participation is for adults aged 18 and over.
You won't know if you're getting the active medicine or placebo.
The study will track your progress over 84 days.

Who may be eligible?

To join this study, you need to be at least 18 years old. Both men and women can take part.

More detailed checks will be done by the study team to make sure it's safe and appropriate for you to participate. These checks might include looking at your medical history and current health.

It's important to discuss your health with the study doctor to see if this trial is a good fit 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 at least 18 years old?
Do you have pain from knee osteoarthritis?
Are you comfortable visiting the clinic for assessments?
Are you willing to take the study medicine as instructed?
Are you able to provide your informed consent?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive either the new medicine (pentosan polysulfate sodium) or a placebo (a dummy medicine). Neither you nor your doctor will know which one you are getting. You will likely have regular visits to the clinic for assessments, which will include answering questions about your pain and how well you can move your knee, and possibly physical examinations.

The main part of the study will involve checking your progress after 56 days. There will also be follow-up checks after 84 days. The study will last for a set period, including these follow-up visits. You will be given specific instructions on how to take the study medicine and any other permitted medicines throughout your participation.

Potential risks and benefits

Taking part in a research study has potential benefits, such as access to a new medicine that might help your knee pain and function before it's widely available. You'll also be contributing to medical knowledge that could help others in the future. However, there are potential risks, including side effects from the medicine, or the medicine not working for you. You might also receive the placebo and not the active drug. You are free to withdraw from the study at any time, for any reason, without it 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
Czechia
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Unverified
Belgium
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Unverified
Poland

Common questions

What is osteoarthritis?

Osteoarthritis is a condition where the protective cartilage on the ends of your bones wears down over time, causing pain, swelling, and stiffness in your joints.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the real medicine but contains no active ingredients. It helps researchers compare how well the new medicine works.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor your study doctor will know which treatment you are receiving. This is called 'double-blind' and ensures fair results.

How long will the study last?

The study will involve checking your progress at 56 days, with further follow-ups at 84 days. The total duration of your participation will be explained by the study team.

What does a 'Phase II and Phase III' study mean?

This means the study combines earlier research (Phase II, which checks if the medicine works) with later research (Phase III, which checks how well it works on a larger group) into one trial.