Pentosan Polysulfate Sodium for Osteoarthritis

Recruiting at 33 trial locations

Overseen By Donna Skerrett

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Paradigm Biopharmaceuticals Ltd.

Must not be taking: Anticoagulants, Antiplatelets, Opioids, NSAIDs

Disqualifiers: Fibromyalgia, Rheumatoid arthritis, Cancer, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 16

Duration: 6 weeks

466 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, pentosan polysulfate sodium (PPS), to determine if it can reduce pain and improve function in people with knee osteoarthritis. Participants will receive either the PPS treatment or a placebo (a harmless substance with no therapeutic effect) to compare results. It targets individuals who have tried other therapies for knee pain without success and experience significant daily knee discomfort. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants the opportunity to contribute to the development of a promising new treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop taking oral and topical NSAIDs and all other systemic pain medications (except allowed rescue medication) from 2 weeks before the study starts until it ends. You can use acetaminophen or certain topical analgesics as rescue therapy if needed.

Is there any evidence suggesting that pentosan polysulfate sodium is likely to be safe for humans?

Research has shown that pentosan polysulfate sodium (PPS) is well-tolerated in past studies. In one study, even at higher doses of 10 mg/kg, PPS did not cause serious drug-related side effects, and participants generally handled it well. This suggests that PPS is safe for use. While the trial under consideration tests a lower dose of PPS, these findings offer some confidence about the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for osteoarthritis?

Unlike the standard treatments for osteoarthritis, which often include NSAIDs, corticosteroids, or physical therapy, Pentosan Polysulfate Sodium (PPS) offers a novel approach. PPS is unique because it is believed to work by targeting the cartilage and potentially promoting its repair, rather than just alleviating symptoms. Researchers are excited about PPS because it could not only relieve pain but also improve joint function by addressing the root cause of cartilage degradation. This could represent a significant advancement in osteoarthritis treatment, offering hope for long-term improvement rather than just temporary relief.

What evidence suggests that this treatment might be an effective treatment for osteoarthritis?

Research has shown that pentosan polysulfate sodium (PPS), which participants in this trial may receive, can help reduce knee pain in people with osteoarthritis (OA). One study found that participants' knee pain scores significantly dropped from an average of 6.39 to 4.18 after just six weeks of treatment. Participants also reported better physical function and quality of life. Another study found that PPS offers long-lasting pain relief and improved joint function for those with knee OA. These results suggest that PPS could be a promising option for managing knee OA pain and enhancing daily activities. ^{2 3 6 7 8}

Who Is on the Research Team?

Chief Medical Officer, Medical

Principal Investigator

Paradigm Biopharmaceuticals

Are You a Good Fit for This Trial?

Adults with knee osteoarthritis (OA) pain, diagnosed by specific criteria and X-ray confirmation. Participants must have tried two types of OA therapies unsuccessfully for at least 6 months and report moderate pain levels. They should not be extremely overweight or underweight and agree to use contraception if applicable.

Inclusion Criteria

I agree to follow the study's birth control requirements.

I can sign the consent form and follow the study's rules.

My knee pain scores between 4 and 9 on a scale of 0-10.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

7 weeks

Treatment

Participants receive twice-weekly subcutaneous injections of pentosan polysulfate sodium or placebo

6 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

Visits every 4-6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pentosan Polysulfate Sodium

Trial Overview

The trial is testing the effectiveness of Pentosan Polysulfate Sodium injections versus placebo in reducing knee OA pain over a period of up to 64 weeks, with a treatment duration of 6 weeks and follow-up visits every 4-6 weeks.

How Is the Trial Designed?

Group I: PPS Active Control 1 Intervention

Pentosan polysulfate sodium 2mg/kg twice weekly for 6 weeks

Group II: Placebo Placebo Group 1 Intervention

Placebo (Sodium Chloride Injection, 0.9%) twice weekly for 6 weeks

Who Is Running the Clinical Trial?

Paradigm Biopharmaceuticals Ltd.

Lead Sponsor

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/NCT04809376

Study Details | NCT04809376 | Treatment Effects of ...

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.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38777590/

Efficacy and safety of pentosan polysulfate sodium in ...

Primary outcome will be the 16-week change in overall average knee pain severity measured using an 11-point Numeric Rating Scale. Main secondary ...

7.

bmjopen.bmj.com

bmjopen.bmj.com/content/14/5/e083046

Efficacy and safety of pentosan polysulfate sodium in ...

Primary outcome will be the 16-week change in overall average knee pain severity measured using an 11-point Numeric Rating Scale. Main secondary ...

8.

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 ...