Osteoarthritis, KneeNCT04814719
Treatment and Duration Effect of Pentosan Polysulfate Sodium (PPS) in Participants With Knee Osteoarthritis Pain
An observational study of Osteoarthritis, Knee, run by Paradigm Biopharmaceuticals Ltd. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Pentosan Polysulphate Sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 24 Jun 2023to 24 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who completed pDay 168 of Study PARA_OA_002 (ie, did not discontinue/withdraw prematurely from the parent study).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Pentosan Polysulphate Sodium, Placebo (Sodium Chloride Injection, 0.9%)
- Keywords
- Osteoarthritis, Knee
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentosan Polysulphate SodiumDrug
Also called PPS
Subcutaneous Injection (100mg/ml)
Placebo (Sodium Chloride Injection, 0.9%)Drug
Also called Sodium Chloride
Placebo to match PPS
| Study group | Role | What they receive |
|---|---|---|
| Pentosan Polysulfate Sodium | Pentosan Polysulfate Sodium (PPS) at Dose and frequency selected in Stage 1 of Parent Study for 6 weeks Receives: Drug: Pentosan Polysulphate Sodium | |
| Placebo | Placebo for 6 weeks Receives: Drug: Placebo (Sodium Chloride Injection, 0.9%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Percentage of participants considered OMERACT- OARSI (Outcomes Measures in Rheumatology - Osteoarthritis Research Society International) responders at each timepoint..
Measured: Week 8, 16, 24, and 34
Assess efficacy of PPS treatment on knee pain in participants with knee OA pain
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.
Measured: 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
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.
Measured: 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
WOMAC NRS 3.1 Index Stiffness average subscale score. Ranges 0-10, 0 is better or none and 10 is extreme or worse.
Measured: 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
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
Measured: Baseline (parent study) pDay1, weeks 8, 16, 24, and 34
Assess effect of PPS on Patient Global Impression of Change (PGIC) in participants with knee OA pain
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".
Measured: Weeks 8, 16, 24 and 34
Change from baseline of the parent study in Quality of Life (QoL) as assessed by Short Form-36 General Health Survey (SF-36)
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.
Measured: Baseline (parent study) pDay1, Weeks 8, 16, 24 and 34
Change from baseline of the parent study in Work Productivity and Activity Impairment (WPAI) questionnaire.
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
Measured: Baseline (parent study) pDay1, Weeks 8, 16, 24 and 34
Assess real-world use of pain medications/therapies, following a single course of PPS
Number of days rescue medication used or use of other pain medications and therapies
Measured: Baseline up to Week 34
Incidence of treatment-emergent AE's, SAE's and AESI of PPS is participants with knee OA pain
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.
Measured: Baseline up to Week 34
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start24 Jun 2023
- Primary completion24 Dec 2024
- Study completion24 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paradigm Biopharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Schnitzer, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814719
- Sponsor's protocol ID
- PARA_OA_006
- Status last verified
- Jul 2025
- First submitted
- 18 Mar 2021
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04814719
- Acronym / sponsor ID
- PARA_OA_006
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Paradigm Biopharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2023 (actual)
- Primary completion
- 24 Dec 2024 (actual)
- Study completion
- 24 Dec 2024 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pentosan Polysulfate Sodium | – | Drug: Pentosan Polysulphate SodiumPentosan Polysulfate Sodium (PPS) at Dose and frequency selected in Stage 1 of Parent Study for 6 weeks |
| Placebo | – | Drug: Placebo (Sodium Chloride Injection, 0.9%)Placebo for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who completed pDay 168 of Study PARA_OA_002 (ie, did not discontinue/withdraw prematurely from the parent study).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pentosan Polysulphate SodiumAlso: PPSSubcutaneous Injection (100mg/ml) | Drug | Pentosan Polysulfate Sodium |
| Placebo (Sodium Chloride Injection, 0.9%)Also: Sodium ChloridePlacebo to match PPS | Drug | Placebo |
Primary outcome
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.
10 secondary outcomes
Assess duration of treatment effect of PPS in participants with OA pain
Time frame: Week 8, 16, 24, and 34
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) 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 (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
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
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
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
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
Assess real-world use of pain medications/therapies, following a single course of PPS
Time frame: Baseline up to Week 34
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Schnitzer principal investigator
Northwestern University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Paradigm Biopharmaceuticals Ltd. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.