PPS Injections for Knee Osteoarthritis

Recruiting at 1 trial location

Overseen By Clinical Operations Director

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Paradigm Biopharmaceuticals USA (INC)

Disqualifiers: Sponsor employee, others

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

Compensation: Varies

Number of Visits: 5

133 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the drug Pentosan Polysulphate Sodium (PPS) for knee osteoarthritis?

Research shows that PPS injections have been effective in treating osteoarthritis in animals and have shown success in osteoarthritis patients. Additionally, a study on dogs with osteoarthritis found that PPS improved lameness, pain, and willingness to exercise, especially at a specific dose. ^{1 2 3 4 5}

Is Pentosan Polysulfate Sodium (PPS) safe for humans?

Pentosan Polysulfate Sodium (PPS) has been studied for safety in humans, showing some potential side effects. In a study for bladder pain syndrome, it was compared to a placebo, and in another study, it was evaluated for knee osteoarthritis. However, in dogs, PPS injections caused temporary bleeding after surgery, suggesting it might affect blood clotting, so caution is advised. ^{3 4 6 7 8}

How is the drug Pentosan Polysulphate Sodium (PPS) unique for treating knee osteoarthritis?

Pentosan Polysulphate Sodium (PPS) is unique for treating knee osteoarthritis because it is administered through subcutaneous injections (under the skin), which may provide better delivery to tissues like bone and cartilage compared to oral treatments. This method has shown effectiveness in reducing symptoms like pain and stiffness in both animal and human studies. ^{1 3 4 5 9}

What is the purpose of this trial?

The purpose of this study is to measure the duration of treatment effect with subcutaneous injections of pentosan polysulfate sodium (PPS) compared with placebo in adult participants with knee osteoarthritis (OA) pain. The study duration will be up to 34 weeks. Participants who completed pDay 162 of Study PARA_OA_002 (i.e. did not discontinue/withdraw prematurely from the parent study) will be invited to participate.

Research Team

Thomas Schnitzer

Principal Investigator

Northwestern University Feinberg School of Medicine

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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 USA (INC)

Lead Sponsor

Trials

2

Recruited

740+

References

1. England pubmed.ncbi.nlm.nih.gov

Clinical trial of intra-articular injection of sodium hyaluronate in patients with osteoarthritis of the knee. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

[Therapy of gonarthrosis using chondroprotective substances. Prospective comparative study of glucosamine sulphate and glycosaminoglycan polysulphate]. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Dose responsive effects of subcutaneous pentosan polysulfate injection in mucopolysaccharidosis type VI rats and comparison to oral treatment. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The effect of pentosan polysulfate sodium for improving dyslipidaemia and knee pain in people with knee osteoarthritis: A pilot study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Systemic use of pentosan polysulphate in the treatment of osteoarthritis. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Pentosan polysulfate sodium for treatment of interstitial cystitis/bladder pain syndrome: insights from a randomized, double-blind, placebo controlled study. [2022]

7. United Kingdom pubmed.ncbi.nlm.nih.gov

Transient Postoperative Hemorrhage from Elbow Arthroscopy Portals following Intra-Articular Pentosan Polysulfate Sodium Injection. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Pentosan polysulfate: a novel therapy for the mucopolysaccharidoses. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

A Pooled Analysis of Two Multicenter, Randomized Controlled Trials of a Single Intra-articular Injection of Gel-200 for Treatment of Osteoarthritis of the Knee. [2023]