PPS Injections for Knee Osteoarthritis

No longer recruiting at 1 trial location

Overseen By Clinical Operations Director

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Paradigm Biopharmaceuticals Ltd.

Disqualifiers: Sponsor employee, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the duration of effects from pentosan polysulfate sodium (PPS) injections for individuals with knee osteoarthritis pain. The study compares PPS with a placebo (a saltwater injection) to determine which is more effective. It seeks participants who have completed a related study and experience knee pain from osteoarthritis. This trial may suit those with consistent knee pain from osteoarthritis who participated in the previous study. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that pentosan polysulfate sodium (PPS) is generally safe for people with knee osteoarthritis. One study found that a dose of 10 mg/kg of PPS was well tolerated, with participants experiencing no serious side effects. Another study confirmed PPS's safety for treating knee osteoarthritis, suggesting that most people can use it without major problems. While some studies have tested PPS in different forms, such as pills or injections, they consistently demonstrate that the treatment is well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for knee osteoarthritis, which typically involve NSAIDs, corticosteroids, or hyaluronic acid injections, Pentosan Polysulfate Sodium (PPS) targets the disease differently. PPS is derived from a sugar-like compound that may help repair cartilage, offering a novel approach by potentially modifying the disease rather than just relieving symptoms. Researchers are excited about PPS because it is administered subcutaneously, which might offer a more convenient and less invasive alternative to the intra-articular injections commonly used. This unique method of action and delivery gives PPS the potential to change how we approach treatment for knee osteoarthritis.

What evidence suggests that PPS injections might be an effective treatment for knee osteoarthritis?

Research has shown that pentosan polysulfate sodium (PPS), a treatment in this trial, can reduce knee pain in people with osteoarthritis. One study found that participants reported a noticeable decrease in pain, with levels dropping from about 6.4 to 4.2 after six weeks of treatment. Other studies have found that these benefits can last, with pain levels remaining lower even up to 26 weeks. Participants also experienced improved joint movement and quality of life. Overall, PPS appears promising for providing lasting pain relief and better mobility for those with knee osteoarthritis. ^{1 2 6 7 8}

Who Is on the Research Team?

Thomas Schnitzer

Principal Investigator

Northwestern University Feinberg School of Medicine

Are You a Good Fit for This Trial?

Adults with knee osteoarthritis pain who completed a previous study (PARA_OA_002) without early withdrawal can join. They must consent to the trial's rules and agree to use only paracetamol or topical analgesics for additional pain relief, avoiding topical NSAIDs.

Inclusion Criteria

I can sign and agree to follow the study's rules.

I agree to use only paracetamol or topical pain relief if needed.

Participants who completed Day 168 of Study PARA_OA_002 (ie, did not discontinue/withdrew prematurely from the parent study).

Exclusion Criteria

I have not had major surgery recently and do not plan any during the study.

I am planning to have total knee reconstruction during the study.

I am not currently in the hospital and do not plan to be during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit (in-person)

Observational Follow-up

Participants are monitored for the duration of treatment effect and long-term safety of PPS

34 weeks

3 phone visits at 8, 16, and 24 weeks; 1 in-person visit at 34 weeks

End of Study

Final assessments and evaluations are conducted at the end of the study

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Pentosan Polysulphate Sodium
• Placebo (Sodium Chloride Injection, 0.9%)
• Subcutaneous Injections

Trial Overview

The trial is testing if injections of Pentosan Polysulfate Sodium (PPS) are effective in treating knee OA pain compared to placebo injections. Participants will receive treatments twice weekly for up to 6 weeks, with the total study lasting up to 80 weeks.

How Is the Trial Designed?

Group I: Placebo Experimental Treatment 1 Intervention

Placebo for 6 weeks

Group II: Pentosan Polysulfate Sodium Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Paradigm Biopharmaceuticals Ltd.

Lead Sponsor

Paradigm Biopharmaceuticals USA (INC)

Lead Sponsor

Trials

2

Recruited

740+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11116866/

Efficacy and safety of pentosan polysulfate sodium in people ...

Main secondary outcomes include change in knee pain, patient global assessment, physical function, quality of life and other structural changes.

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2665913123000109

Clinical Trial The effect of pentosan polysulfate sodium for ...

Knee pain NRS was significantly reduced at weeks 6, 16 and 26 from 6.39 ​± ​1.33 to 4.18 ​± ​1.99, 3.63 ​± ​2.28 and 4.38 ​± ​2.55, respectively (P ​< ​0.001).

3.

oarsijournal.com

oarsijournal.com/article/S1063-4584(24)00122-5/fulltext

066 - effects of pentosan polysulfate sodium on clinical ...

These results demonstrate the promising effects of iPPS for durable pain relief and improved function in participants with knee OA.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06917404

NCT06917404 | A Study to Investigate the Treatment Effect ...

The purpose of this study is to measure the change in pain and function with subcutaneous injections of pentosan polysulfate sodium (PPS) compared with ...

5.

progressivespecialists.com.au

progressivespecialists.com.au/pentosan-a-new-horizon-in-osteoarthritis-treatment

Pentosan: A New Horizon in Osteoarthritis Treatment

Recent clinical trials have shown promising results, with patients reporting significant improvements in pain management, joint function, and ...

6.

paradigmbiopharma.com

paradigmbiopharma.com/wp-content/uploads/2022/06/PPS-for-Knee-OA-BA-2022-16MAY2022-Final.pdf

Injectable Pentosan Polysulfate Sodium For Knee ...

These data support an acceptable safety profile for Paradigm's PPS product for the OA indication development. • A pilot phase 1, open-label study of 2 mg/kg ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2873929/

Sodium pentosan polysulfate resulted in cartilage ...

The objective of this study was to assess the efficacy, safety, and patient satisfaction in patients with mild radiographic knee osteoarthritis (OA) findings ...

8.

oarsijournal.com

oarsijournal.com/article/S1063-4584(23)00086-9/fulltext

An Exploratory, Phase 2 Clinical Trial In Knee ...

An exploratory, Phase 2 clinical trial in knee osteoarthritis subjects suggests therapeutic effects of pentosan polysulfate sodium on synovial fluid biomarkers.