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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04814719
Registration number
NCT04814719
Ethics application status
Date submitted
18/03/2021
Date registered
24/03/2021
Date last updated
8/04/2024
Titles & IDs
Public title
An Observational Follow-up Study to Evaluate Duration of Treatment Effect of Pentosan Polysulfate Sodium in Participants With Knee Osteoarthritis Pain
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Scientific 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
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Secondary ID [1]
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PARA_OA_006
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Drugs - Pentosan Polysulphate Sodium
Treatment: Drugs - Placebo (Sodium Chloride Injection, 0.9%)
Pentosan Polysulfate Sodium - Pentosan Polysulfate Sodium (PPS) at Dose and frequency selected in Stage 1 of Parent Study for 6 weeks
Placebo - Placebo for 6 weeks
Treatment: Drugs: Pentosan Polysulphate Sodium
Subcutaneous Injection (100mg/ml)
Treatment: Drugs: Placebo (Sodium Chloride Injection, 0.9%)
Placebo to match PPS
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To evaluate the duration of treatment effect of PPS in participants with OA pain
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Assessment method [1]
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Time from initial response in the parent study (PARA_OA_002) to loss of OMERACT-OARSI response.
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Timepoint [1]
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From initial response time baseline in parent study up to 34 weeks
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Secondary outcome [1]
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To evaluate the duration of treatment effect of PPS in participants with OA pain
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Assessment method [1]
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Percentage of participants considered OMERACT- OARSI responders at each timepoint..
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Timepoint [1]
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Week 8, 16, 24, and 34
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Secondary outcome [2]
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To evaluate the efficacy of PPS treatment on knee pain in participants with knee OA pain
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Assessment method [2]
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WOMAC NRS 3.1 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
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Timepoint [2]
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Baseline (parent study) pDay1, weeks 8, 16, 24, and 34
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Secondary outcome [3]
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WOMAC NRS 3.1 assessment of knee function in participants with knee OA pain
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline (parent study) pDay1, weeks 8, 16, 24, and 34
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Secondary outcome [4]
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WOMAC NRS 3.1 knee stiffness assessment in participants with knee OA
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Assessment method [4]
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WOMAC NRS 3.1 Index Stiffness average subscale score.
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Timepoint [4]
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Baseline (parent study) pDay1, weeks 8, 16, 24, and 34
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Secondary outcome [5]
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Overall score WOMAC NRS 3.1in participants with knee OA
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Assessment method [5]
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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
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Timepoint [5]
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Baseline (parent study) pDay1, weeks 8, 16, 24, and 34
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Secondary outcome [6]
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To evaluate the effect of PPS on Patient Global Impression of Change (PGIC) in participants with knee OA pain
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Assessment method [6]
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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".
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Timepoint [6]
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Weeks 8, 16, 24 and 34
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Secondary outcome [7]
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Change from baseline of the parent study in Quality of Life (QoL) as assessed by Short Form-36 General Health Survey (SF-36)
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline (parent study) pDay1, Weeks 8, 16, 24 and 34
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Secondary outcome [8]
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Change from baseline of the parent study in Work Productivity and Activity Impairment (WPAI) questionnaire.
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Assessment method [8]
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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
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Timepoint [8]
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Baseline (parent study) pDay1, Weeks 8, 16, 24 and 34
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Secondary outcome [9]
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To evaluate the real-world use of pain medications/therapies, following a single course of PPS
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Assessment method [9]
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Number of days rescue medication used or use of other pain medications and therapies
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Timepoint [9]
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Baseline up to Week 34
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Secondary outcome [10]
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To Evaluate the safety and tolerability of PPS is participants with knee OA pain
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Assessment method [10]
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Incidence of SAE's, AE's, causally to IP, AE's of Special Interest (AEST), AE's requireing any intervention for index knee pain and AE's requiring pain medication.
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Timepoint [10]
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Baseline up to Week 34
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/06/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
24/12/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
133
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Emeritus Research - Camberwell
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Recruitment postcode(s) [1]
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3124 - Camberwell
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Illinois
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Paradigm Biopharmaceuticals USA (INC)
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04814719
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Thomas Schnitzer
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Address
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Northwestern University Feinberg School of Medicine
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04814719
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