NCT04814719

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
2.3 years until next milestone

Study Start

First participant enrolled

June 24, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2024

Completed
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

1.5 years

First QC Date

March 18, 2021

Last Update Submit

July 17, 2025

Conditions

Osteoarthritis, Knee

Keywords

OsteoarthritisKnee

Outcome Measures

Primary Outcomes (1)

  • Assess duration of treatment effect of PPS in participants with OA pain

    Time from initial response in the parent study (PARA\_OA\_002) to loss of OMERACT-OARSI (Outcomes Measures in Rheumatology - Osteoarthritis Research Society International) response.

    From initial response time baseline in parent study up to 34 weeks

Secondary Outcomes (10)

  • Assess duration of treatment effect of PPS in participants with OA pain

    Week 8, 16, 24, and 34

  • Assess efficacy of PPS treatment on knee pain in participants with knee OA pain

    Baseline (parent study) pDay1, weeks 8, 16, 24, and 34

  • WOMAC NRS 3.1 (Western Ontario and McMaster Universities Osteoarthritis Index) assessment of knee function in participants with knee OA pain

    Baseline (parent study) pDay1, weeks 8, 16, 24, and 34

  • WOMAC NRS 3.1 (Western Ontario and McMaster Universities Osteoarthritis Index) knee stiffness assessment in participants with knee OA

    Baseline (parent study) pDay1, weeks 8, 16, 24, and 34

  • Overall score WOMAC NRS 3.1 (Western Ontario and McMaster Universities Osteoarthritis Index) in participants with knee OA

    Baseline (parent study) pDay1, weeks 8, 16, 24, and 34

  • +5 more secondary outcomes

Other Outcomes (7)

  • Change in subchondral Bone Marrow Lesion (BML) on Magnetic Resonance Imaging (MRI) from baseline of the parent study.

    Baseline (parent study) pDay1 and at Week 34

  • Change in joint synovitis/effusion volume on MRI

    Baseline (parent study) pDay1 and at Week 34

  • Effect of PPS on Change in cartilage volume on MRI

    Baseline (parent study) pDay1 and at Week 34

  • +4 more other outcomes

Study Arms (2)

Pentosan Polysulfate Sodium

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

Drug: Pentosan Polysulphate Sodium

Placebo

Placebo for 6 weeks

Drug: Placebo (Sodium Chloride Injection, 0.9%)

Interventions

Pentosan Polysulphate SodiumDRUG

Subcutaneous Injection (100mg/ml)

Also known as: PPS
Pentosan Polysulfate Sodium
Placebo (Sodium Chloride Injection, 0.9%)DRUG

Placebo to match PPS

Also known as: Sodium Chloride
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants who completed pDay 168 of Study PARA\_OA\_002 (ie, did not discontinue/withdraw prematurely from the parent study).

You may qualify if:

  • Participants who completed Day 168 of Study PARA\_OA\_002 (ie, did not discontinue/withdrew prematurely from the parent study).
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

You may not qualify if:

  • An employee of the Sponsor, clinical research organisations or research site personnel directly affiliated with this study or their immediate family members defined as a spouse, parent, sibling, or child, whether biological or legally adopted.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Emeritus Research

Camberwell, Victoria, 3124, Australia

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

Pentosan Sulfuric PolyesterSodium Chloride

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Sulfuric AcidsSulfur AcidsSulfur CompoundsOrganic ChemicalsPolysaccharidesCarbohydratesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Thomas Schnitzer

    Northwestern University Feinberg School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2021

First Posted

March 24, 2021

Study Start

June 24, 2023

Primary Completion

December 24, 2024

Study Completion

December 24, 2024

Last Updated

July 22, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)US(1)