MaRVeL Study

The MaRVeL study is a 6-month research study testing a new treatment for knee osteoarthritis. The treatment is Pentosan Polysulate Sodium. Pentosan Polysulfate Sodium is already approved in Australia to treat chronic bladder inflammation under the brand name Elmiron.

The aim of this study is to find out if Pentosan Polysulfate Sodium can also help improve knee pain in people with knee osteoarthritis and elevated cholesterol.

Pentosan Polysulfate Sodium is in a capsule and will be taken orally. Our research team has already tested this medication in a previous smaller trial.

In the MaRVeL study, we're using a randomised placebo-controlled approach. This means we're comparing how well the supplement works against a placebo (a dummy pill with no active ingredients). Participants are randomly assigned to either take the Pentosan Polysulfate Sodium capsule or the placebo capsule. This helps to see if the medicine really helps to improve knee pain.

The survey will take approximately 10 minutes to complete.

Study aims

Aim 1

To test whether oral Pentosan Polysulfate Sodium can reduce knee pain in people with knee osteoarthritis, compared to placebo

Aim 2

To test whether oral Pentosan Polysulfate Sodium can reduce cholesterol levels in people with knee osteoarthritis, compared to placebo

Who can take part?

The study is suitable for people who:

• Have internet access and an active email account

• Are 40 years of age or older

• Are able to attend Royal North Shore Hospital (RNSH) in St Leonards in person up to 6 times over the 6-month study period

• Have knee pain on most days over the last month

• Have a history of high cholesterol levels

• Are not taking blood thinners or statins

• Agree to maintain their usual activity level and diet throughout the study

• Agree to stop taking non-steroidal anti-inflammatories (e.g Neurofen and Meloxicam) for the duration of the study

What is involved for participants?

• If you are interested in participating in this study, you will be asked to fill out an online screening survey to see if the study is suitable for you.

• Your study participation will last for about 6 months.

• During the screening process, you will be required to attend Royal North Shore Hospital for a blood test and x-ray.

• There will be an extra 4-5 in-person visits over a 6-month period where blood, urine and FOB tests will be completed and you will be asked to complete a study survey.

• You must stop using NSAIDs (anti-inflammatory drugs, e.g. Nurofen, Celebrex, Mobic, etc.), high doses of aspirin (>325mg), opioids (such as Tramadol) and steroids (Voltaren), except creams or gels applied to the skin.

• Your capsule must be taken at the recommended oral dose once every 4 days and for two 5-weeks cycles.

• Eating and drinking (e.g. milk, tea, coffee) interfere with the absorption of the study medication and so it is very important that you do not eat or drink for one hour before taking the medication and that you take study medication at least two hours after meals.

Interested in joining the study?

The survey will take approximately 10 minutes to complete. You can save your progress and return at any time.

MaRVEL study FAQs

  • Your study participation will last for about 6 months after your first study visit.

  • You will be required to take your recommended oral dose once every 4 days and for two 5-weeks cycles.

    Eating and drinking (e.g. milk, tea, coffee) interfere with the absorption of the study medication and so it is very important that you do not eat or drink for one hour before taking the medication and that you take study medication at least two hours after meals.

  • During the study, you are allowed to take Panadol or Panadol Osteo to treat worsening pain, whether or not that pain is associated with osteoarthritis (e.g., may be used for example to treat a headache, acute injury, etc.). While we do ask you to refrain from using oral NSAIDs (e.g. Nurofen), you can continue to use gels such as Voltaren gel to help with knee pain.

  • No. This is a randomised trial meaning that participants will be randomly assigned to either the active treatment group or the placebo group.

    There is a 50/50 chance of being allocated to either group.

  • We will provide you meal vouchers on every visit (for Zouki Café within RNSH) and a free parking voucher for all the study visits at Royal North Shore Hospital.

    Castlereagh Imaging centres at St. Leonards and Cremorne have their free independent car parking facility. You can use the parking at these centres at no further expense.

    You will not be required to pay for any scans and will recieve copies of all results.

  • During your participation in the study, you will need to visit the study site approximately 4-5 times. This does not include the X-ray and MRI visit which occurs during the eligibility screening process.

  • No. We require all participants to have a X-rays and MRI taken at the assigned study site. The requirements of the scans are specific to the study to ensure that all participants are assessed in the same way. The study sites have been briefed with the requirements of the study.

    You will not be charged for any tests and will recieve all results.

  • Blood samples are collected for health monitoring purposes while you remain in the study. Our study doctor will review any abnormal results and contact you accordingly.

  • If you are interested in joining the study, you will need to complete the online screening survey here. If you meet the eligibility criteria, the study team will be in contact via email or phone.

  • Yes. At the end of your time in the study, you will be notified via email whether you were allocated to the treatment group or the placebo group.

Do you have a question?

If you have a question or would like further information about the study, please send an email to

marvel.study@sydney.edu.au

Join the MaRVeL study

Is chronic knee pain impacting your daily life? We may be able to help: