Pentosan Polysulphate Sodium for Osteoarthritis, Knee

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Osteoarthritis, Knee+1 More
Pentosan Polysulphate Sodium - Drug
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

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

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 preview

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.