Pentosan Polysulphate Sodium for Osteoarthritis, Knee

Phase-Based Progress Estimates

Effectiveness

Safety

Osteoarthritis, Knee+1 More

Pentosan Polysulphate Sodium - Drug

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Eligibility

18+

All Sexes

What conditions do you have?

Select

Eligibility

18+

All Sexes

What conditions do you have?

Select

Study Summary

This trial is testing the effectiveness of a drug called pentosan polysulfate sodium (PPS) for treating knee pain caused by osteoarthritis. The study will last up to 80 weeks, and participants will receive either PPS injections or placebo injections.

Eligible Conditions

Osteoarthritis, Knee

Treatment Effectiveness

Effectiveness Progress

2 of 3

This is further along than 85% of similar trials

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Pentosan Polysulfate Sodium

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Study Objectives

2 Primary · 25 Secondary · Reporting Duration: Baseline, Days 11, 25, 39, 56, 84 112, 140 and 168

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

Alopecia

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 Progress

3 of 3

This is further along than 85% of similar trials

Similar Trials

JointStem

Pentosan Polysulfate Sodium

SL-1002

Trial Design

2 Treatment Groups

Pentosan Polysulfate Sodium

1 of 2

Placebo

1 of 2

Experimental Treatment

Non-Treatment Group

938 Total Participants · 2 Treatment Groups

Primary Treatment: Pentosan Polysulphate Sodium · Has Placebo Group · Phase 3

Pentosan Polysulfate Sodium

Drug

Experimental Group · 1 Intervention: Pentosan Polysulphate Sodium · Intervention Types: Drug

Placebo

Drug

PlaceboComparator Group · 1 Intervention: Placebo (Sodium Chloride Injection, 0.9%) · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks

Treatment: Varies

Reporting: baseline, days 11, 25, 39, 56, 84 112, 140 and 168

Who is running the clinical trial?

Paradigm Biopharmaceuticals USA (INC)Lead Sponsor

1 Previous Clinical Trials

938 Total Patients Enrolled

1 Trials studying Osteoarthritis, Knee

938 Patients Enrolled for Osteoarthritis, Knee

Thomas SchnitzerPrincipal InvestigatorNorthwestern University Feinberg School of Medicine

1 Previous Clinical Trials

938 Total Patients Enrolled

1 Trials studying Osteoarthritis, Knee

938 Patients Enrolled for Osteoarthritis, Knee

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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.

Can sign an informed consent form, agreeing to the conditions listed in the form and in this protocol.

People who finished Day 168 of the study PARA_OA_002 did not stop or withdraw from the study prematurely.

About The Reviewer

Michael Gill - B. Sc.

First Published: October 3rd, 2021

Last Reviewed: November 29th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References