Pentosan Polysulphate Sodium for Osteoarthritis, Knee

Phase-Based Estimates
2
Effectiveness
3
Safety
Emeritus Research, Camberwell, Australia
Osteoarthritis, Knee+1 More
Pentosan Polysulphate Sodium - Drug
Eligibility
18+
All Sexes
Eligible conditions
Osteoarthritis, Knee

Study Summary

A Study to Investigate The Duration of Treatment Effect and Re-treatment With Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo in Adult Participants With Knee Osteoarthritis Pain

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Eligible Conditions

  • Osteoarthritis, Knee
  • Arthrosis
  • Osteoarthritis

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Pentosan Polysulphate Sodium will improve 2 primary outcomes, 25 secondary outcomes, and 7 other outcomes in patients with Osteoarthritis, Knee. Measurement will happen over the course of From initial response time in parent study upto Week 28.

Week 12
Change from baseline of the parent study as assessed by the average overall score of the Western Ontario and McMaster Universities (WOMAC®) numeric rating scale (NRS) 3.1 Index at Weeks 12, 28, 40, 52, and 80
Change from baseline of the parent study in function as assessed by the average function sub-scale score of the Western Ontario and McMaster Universities (WOMAC®) numeric rating scale (NRS) 3.1 Index at Weeks 12, 28, 40, 52, and 80
Change from baseline of the parent study in function of >=25% and >=50% as assessed by the average function sub-scale score of the WOMAC® NRS 3.1 Index at Weeks 12, 28, 40, 52, and 80
Change from baseline of the parent study in knee pain as assessed by the average pain sub-scale score of the Western Ontario and McMaster Universities (WOMAC®) numeric rating scale (NRS) 3.1 Index at Weeks 12, 28, 40, 52, and 80
Change from baseline of the parent study in knee pain of >=25% and >=50% as assessed by the average pain sub-scale score of the WOMAC® NRS 3.1 Index at Weeks 12, 28, 40, 52, and 80
Change from baseline of the parent study in stiffness as assessed by the average stiffness sub-scale score of the Western Ontario and McMaster Universities (WOMAC®) numeric rating scale (NRS) 3.1 Index at Weeks 12, 28, 40, 52, and 80
Week 28
Change in bone shape on MRI from baseline of the parent study at Week 28 and 80
Change in cartilage volume on MRI from baseline of the parent study at Week 28 and 80
Change in joint space width on MRI from baseline of the parent study at Week 28 and 80
Change in joint space width on X-ray from baseline of the parent study at Week 28 and 80
Change in joint synovitis/effusion volume on MRI from baseline of the parent study at Week 28 and 80
Change in subchondral Bone Marrow Lesion (BML) area and volume on Magnetic Resonance Imaging (MRI) from baseline of the parent study at Week 28 and 80
Day 168
Incidence of Treatment Emergent Adverse Events (TEAE) through Treatment to Day 168
Incidence of Treatment-emergent clinical laboratory abnormalities from treatment to end of study
Week 80
Incidence of Serious Adverse Events (SAE), Adverse Events (AE) related to the Investigational Product (IP), and AEs related to any intervention for knee pain through followup to end of study
Number of days of rescue medication used from through followup to end of study
Day 11
Change from baseline in function of >=25% and >=50% as assessed by the average function sub-scale score of the WOMAC® NRS 3.1 Index at Treatment Days 11, 25, 39, 84, 112, 140 and 168
Change from baseline in knee pain of >=25% and >=50% as assessed by the average pain sub-scale score of the WOMAC® NRS 3.1 Index at Treatment Days 11, 25, 39, 84, 112, 140 and 168
Day 11
Number of participants with an Anti-Drug-Antibody (ADA) response at Days 11, 25, 39, 56 and 84
Day 11
Change from baseline at Treatment Days 11, 25, 39, 56, 84, 112, 140, and 168 in Quality of Life (QoL) as assessed by Short Form-36 General Health Survey (SF-36)
Change from baseline at Treatment Days 11, 25, 39, 84, 112, 140 and 168 as assessed by the average overall score of the WOMAC® NRS 3.1 Index.
Change from baseline at Treatment Days 11, 25, 39, 84, 112, 140 and 168 in function as assessed by the average function sub-scale score of the WOMAC® NRS 3.1 Index.
Change from baseline at Treatment Days 11, 25, 39, 84, 112, 140 and 168 in knee pain as assessed by the average pain sub-scale score of the WOMAC® NRS 3.1 Index.
Change from baseline at Treatment Days 11, 25, 39, 84, 112, 140 and 168 in stiffness as assessed by the average function sub-scale score of the WOMAC® NRS 3.1 Index.
Day 11
Percentage of participants meeting OMERACT-OARSI Responder Index at Treatment Days 11, 25, 39, 56, 84, 112, 140 and 168
Day 168
Number of days of rescue medication used from Treatment Day 1 through Day 168
Day 39
Patient Global Impression of change at Day 39, 84, 112, 140 and 168
Day 56
Change from baseline at Treatment Days 56, 84, 112, 140, and 168 in Work Productivity and Activity Impairment (WPAI) questionnaire score
Week 28
Time from initial response in the parent study (PARA_OA_002) to loss of OMERACT-OARSI response through Follow-up Week 28 (Part 1)
Week 80
Time from initial response in the parent study (PARA_OA_002) to loss of OMERACT-OARSI response through Follow-up Week 80 (Part 2)
Week 12
Percentage of participants meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International - Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Week 12, 28, 40, 52 and 80
Week 12
Change from baseline of the parent study at Weeks 12, 28, 40, 52 and 80 in Quality of Life (QoL) as assessed by Short Form-36 General Health Survey (SF-36)
Change from baseline of the parent study at Weeks 12, 28, 40, 52 and 80 in Work Productivity and Activity Impairment (WPAI) questionnaire.
Patient Global Impression of Change (PGIC) at Weeks 12, 28, 40, 52 and 80

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Placebo
Pentosan Polysulfate Sodium
Placebo group

This trial requires 938 total participants across 2 different treatment groups

This trial involves 2 different treatments. Pentosan Polysulphate Sodium is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Pentosan Polysulfate Sodium
Drug
Pentosan Polysulfate Sodium (PPS) at Dose and frequency selected in Stage 1 of Parent Study for 6 weeks
Placebo
Drug
Placebo for 6 weeks

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, days 11, 25, 39, 56, 84 112, 140 and 168
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, days 11, 25, 39, 56, 84 112, 140 and 168 for reporting.

Closest Location

Northwestern University Feinberg School of Medicine - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Agrees to continue using paracetamol or topical analgesics (such as ibuprofen) as needed, if required. show original
Can sign an informed consent form, agreeing to the conditions listed in the form and in this protocol. show original
People who finished Day 168 of the study PARA_OA_002 did not stop or withdraw from the study prematurely. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes osteoarthritis, knee?

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Genetic and neurological predisposition are the strongest risk factors for developing osteoarthritis. On average, women live one year less than men of the same age.

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What are the signs of osteoarthritis, knee?

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Osteoarthritis is a degenerative disease of articular cartilage and bone. It usually begins with moderate symptoms and includes stiffness, pain at the joints, and occasional locking or locking pain. Knee swelling is a key feature of osteoarthritis. Symptoms of osteoarthritis in many cases can be reduced or prevented through modification of risk factors and prevention of osteoarthritis. Some early osteoarthritis signs include early onset of osteoarthritis following an injury, persistent pain and swelling, and decreased range of motion. Late osteoarthritis signs include pain in the joints, which usually increases with activity.

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What are common treatments for osteoarthritis, knee?

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OA of the knee is commonly treated with analgesics, NSAIDs, exercise and tibial nerve stimulation at the Mayo Clinic in Rochester and other clinics in the United States. Patients are encouraged to seek independent evaluation of their condition from their clinician. In addition, the disease may be treated effectively in those wishing to avoid medication as part of their treatment plan.

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What is osteoarthritis, knee?

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Osteoarthritis, knee is a knee disorder, affecting people of all ages. Symptoms commonly include stiffness, pain, weakness or loss of mobility. There are several causes and several diagnostic options. Treatment depends on the degree of symptoms people are suffering from.

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How many people get osteoarthritis, knee a year in the United States?

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Approximately 24% of all adults have knee osteoarthritis at some point during their lives. The rates of knee osteoarthritis vary by race, sex, and education level.

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Can osteoarthritis, knee be cured?

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While the evidence is limited, it is generally supportive of the principle of evidence-based medicine, which suggests that no cure exists for [knee osteoarthritis](https://www.withpower.com/clinical-trials/knee-osteoarthritis) and a cure for osteoarthritis is unlikely to be found.

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What is the latest research for osteoarthritis, knee?

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The most recent research findings for osteoarthritis are encouraging, and there is some evidence that there is some benefit for a subset of patients. It will take time before we can come to a consensus regarding the benefits and risks of these treatments. The most recent systematic review of complementary and alternative treatments concluded that there is only minimal evidence supporting their effectiveness. Other reviews will be published in the future.

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What are the latest developments in pentosan polysulphate sodium for therapeutic use?

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Recent findings of this study suggest that PPS is safe and effective in reducing pain and improving function with less side effects. PPS has been licensed for this indication since October 2017.

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What is the primary cause of osteoarthritis, knee?

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The knee was the most prevalent site of OA and seemed to be the site of origin of disease. Recent findings support our hypothesis of the knee being the location of OA disease.

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What is pentosan polysulphate sodium?

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The efficacy of PPS may be enhanced when PPS solution is diluted 100-fold into the standard PVS. It was found that this dilution can be safely added and maintained in the circulation for at least 3 months.

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Is pentosan polysulphate sodium typically used in combination with any other treatments?

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The frequency of use of PPBS as a single treatment was less than 10%; however, the prescription of PPBS in the presence of other medical therapies, especially those that affect blood pressure, was not uncommon. This suggests that PPBS is typically used in combination with other treatments known to affect blood pressure. Although not as popular, PPBS may be more effective as a monotherapy. The use of PPBS should be reconsidered, based on these findings.

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How serious can osteoarthritis, knee be?

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Results from a recent clinical trial demonstrates that patients suffering from knee osteoarthritis have to treat and compensate more. While their daily lives are affected to an extent, they are still able to perform most tasks in daily living. The daily lives of the patients are not dependent to the amount of pain.

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