Skip to main content
OpenTrials
Completed

NCT Number: NCT04814719

Treatment and Duration Effect of Pentosan Polysulfate Sodium (PPS) in Participants With Knee Osteoarthritis Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Emeritus Research, Camberwell, Victoria, Australia

Loading trial locations.

About this study

This is an observational study to determine duration of treatment effect and assess long-term safety up to 52 weeks post PPS use for 6 weeks in parent study (PARA_OA_002). The duration of treatment effect will be evaluated by the OMERACT-OARSI responder criteria for knee OA.

Eligible participants will be enrolled in Study PARA_OA_006 at the completion of the parent study PARA_OA_002. There will be no intervention in this observational study.

Participants will attend screening (visit 1), three phone visits at 8, 16, and 24 weeks, and an EOS (end of study) visit 34 weeks at the site, a total of 5 visits. Participants questionnaires include WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) NRS 3.1 Index, PGIC (Patients Global Impression of Change), WPAI (Work Productivity and Activity Impairment) and quality of life SF-36.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Pentosan Polysulphate Sodium

Drug

Subcutaneous Injection (100mg/ml)

Other names: PPS

Placebo (Sodium Chloride Injection, 0.9%)

Drug

Placebo to match PPS

Other names: Sodium Chloride

Primary outcomes

  1. Assess duration of treatment effect of PPS in participants with OA pain

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

    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.

Secondary outcomes

  1. Assess duration of treatment effect of PPS in participants with OA pain

    Time frame: Week 8, 16, 24, and 34

    Percentage of participants considered OMERACT- OARSI (Outcomes Measures in Rheumatology - Osteoarthritis Research Society International) responders at each timepoint..

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

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

    WOMAC NRS 3.1 (Western Ontario and McMaster Universities Osteoarthritis Index) Index Pain average subscale score. Reduction in knee pain of ≥30% and ≥50% as assessed by the average pain WOMAC NRS 3.1 subscale score. Ranges 0-10 with 0 represents no pain and 10 represents extreme pain.

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

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

    WOMAC NRS 3.1 Index Function WOMAC NRS 3.1 Index.. Improvement of function assessed of ≥30% and ≥50% as assessed by the average Function subscale score (knee) during the past 48 hours. Ranges Scoring 0-10, 0 is better or none and 10 is worse.

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

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

    WOMAC NRS 3.1 Index Stiffness average subscale score. Ranges 0-10, 0 is better or none and 10 is extreme or worse.

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

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

    WOMAC NRS 3.1 Index Overall average subscale score The WOMAC® NRS 3.1 Index consists of 24 questions and produces 3 sub-scales scores for pain (5 questions), stiffness (2 questions), and function (17 questions) and a total score that summarizes overall disability. Score of 0 is better and the higher score is worse

  6. Assess effect of PPS on Patient Global Impression of Change (PGIC) in participants with knee OA pain

    Time frame: Weeks 8, 16, 24 and 34

    The PGIC is a self-administered question that rates participants overall improvement in chronic pain since beginning treatment from 1 "no change (or condition has worsened)" to 7 "a great deal better" in response to the question "Since beginning treatment, how would you describe the change (if any) in activity, limitation, symptoms, emotions, and overall QoL related to your arthritis".

  7. Change from baseline of the parent study in Quality of Life (QoL) as assessed by Short Form-36 General Health Survey (SF-36)

    Time frame: Baseline (parent study) pDay1, Weeks 8, 16, 24 and 34

    The SF-36 v2 is a 36-item, patient-reported survey of patient health, consisting of 8 scaled scores, which are the weighted sums of the questions in their section. The 1-week recall form asks the respondent to answer the questions as they pertain to the way he or she felt or acted during the past week. Score ranges 0-100 higher scores indicate better health.

  8. Change from baseline of the parent study in Work Productivity and Activity Impairment (WPAI) questionnaire.

    Time frame: Baseline (parent study) pDay1, Weeks 8, 16, 24 and 34

    This WPAI questionnaire (WPAI:OA-knee) is a validated self-administered questionnaire that assesses work impairment due to OA . The questionnaire gathers information on employment status, hours worked, hours missed due to OA, and hours missed for any other reasons

  9. Assess real-world use of pain medications/therapies, following a single course of PPS

    Time frame: Baseline up to Week 34

    Number of days rescue medication used or use of other pain medications and therapies

  10. Incidence of treatment-emergent AE's, SAE's and AESI of PPS is participants with knee OA pain

    Time frame: Baseline up to Week 34

    Data of SAE's, AE's, causally to IP, AE's of Special Interest (AEST), AE's requiring any intervention for index knee pain and AE's requiring pain medication.

Other outcomes

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

    Time frame: Baseline (parent study) pDay1 and at Week 34

    MRIs will be reviewed by an independent trained reader blinded to participant characteristics, study information and timing of MRI scans. All measurement will be done in duplicate

  2. Change in joint synovitis/effusion volume on MRI

    Time frame: Baseline (parent study) pDay1 and at Week 34

    MRIs will be reviewed by an independent trained reader blinded to participant characteristics, study information and timing of MRI scans. All measurement will be done in duplicate

  3. Effect of PPS on Change in cartilage volume on MRI

    Time frame: Baseline (parent study) pDay1 and at Week 34

    MRIs will be reviewed by an independent trained reader blinded to participant characteristics, study information and timing of MRI scans. All measurement will be done in duplicate

  4. Change in bone shape on MRI and whether these correlate with clinical outcomes

    Time frame: Baseline (parent study) pDay1 and at Week 34

    MRIs will be reviewed by an independent trained reader blinded to participant characteristics, study information and timing of MRI scans. All measurement will be done in duplicate

  5. Change in joint space width on X-ray

    Time frame: Baseline (parent study) pDay1 and at Week 34

    X-Rays will be reviewed by an independent trained reader blinded to participant characteristics, study information and timing of MRI scans. All measurement will be done in duplicate

  6. Change in joint space width on MRI

    Time frame: Baseline (parent study) pDay1 and at Week 34

    MRIs will be reviewed by an independent trained reader blinded to participant characteristics, study information and timing of MRI scans. All measurement will be done in duplicate

  7. Explore any correlation between joint space width measurements from x-rays and MRI

    Time frame: Week 34

    MRIs and x-rays will be reviewed by an independent trained reader blinded to participant characteristics, study information and timing of MRI scans and x-rays. All measurement will be done in duplicate.

Sponsors and collaborators

Lead sponsor

Paradigm Biopharmaceuticals Ltd.

Industry

Registry information

Official study title

An Observational Follow-up Study to Investigate the Duration of Treatment Effect With Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo in Adult Participants With Knee Osteoarthritis Pain

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 24, 2021
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.