Osteoarthritis of the Knee
Osteoarthritis of the Knee.
A phase 2b, randomised double blind placebo controlled multicentre study to evaluate the effects of pentosan polysulfate sodium in treating subjects with osteoarthritis of the knee and subchondral bone marrow lesions.
The main aim of this study is to see whether Pentosan Polysulfate Sodium (PPS) injection given under the skin (subcutaneously) is safe and effective in treating knee pain, and improving knee function in people with knee osteoarthritis and subchondral bone marrow lesions (BMLs). Bone Marrow Lesions in simple terms are pockets of fluid and/or abnormal tissue found within bone. It is believed that BMLs contribute to pain in the area where it is located. PPS has been used to treat bladder pain and prevent deep vein thrombosis (blood clots) for more than 50 years. PPS injections for knee osteoarthritis is an experimental treatment. This means that it must be tested to see if it is an effective and safe treatment for knee osteoarthritis with BMLs.
If you agree to participate in the study you will be required to have up to 15 visits to the clinic and include a course of 12 injections given over a period of 6 weeks. You will be randomly (like flipping a coin) allocated to receive either PPS or placebo (an inactive injection that looks the same as the PPS injection). You will not be able to choose which treatment you receive.
There are no additional costs to you associated with participating in this research project nor will you be paid. All medication, tests and medical care required as part of the research project will be provided to you free of charge. You will not receive any payment for participation in this study apart from reimbursement for reasonable travel costs for study visits during the study.
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