An Observational Follow-up Study to Evaluate Duration of Treatment Effect of Pentosan Polysulfate Sodium in Participants With Knee Osteoarthritis Pain
- Conditions
- Osteoarthritis, Knee
- Interventions
- Drug: Pentosan Polysulphate SodiumDrug: Placebo (Sodium Chloride Injection, 0.9%)
- Registration Number
- NCT04814719
- Lead Sponsor
- Paradigm Biopharmaceuticals USA (INC)
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 133
- 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.
• 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pentosan Polysulfate Sodium Pentosan Polysulphate Sodium Pentosan Polysulfate Sodium (PPS) at Dose and frequency selected in Stage 1 of Parent Study for 6 weeks Placebo Placebo (Sodium Chloride Injection, 0.9%) Placebo for 6 weeks
- Primary Outcome Measures
Name Time Method To evaluate the duration of treatment effect of PPS in participants with OA pain 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 response.
- Secondary Outcome Measures
Name Time Method To evaluate the duration of treatment effect of PPS in participants with OA pain Week 8, 16, 24, and 34 Percentage of participants considered OMERACT- OARSI responders at each timepoint..
To evaluate the 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 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
WOMAC NRS 3.1 assessment of knee function in participants with knee OA pain 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.
WOMAC NRS 3.1 knee stiffness assessment in participants with knee OA Baseline (parent study) pDay1, weeks 8, 16, 24, and 34 WOMAC NRS 3.1 Index Stiffness average subscale score.
Overall score WOMAC NRS 3.1in participants with knee OA 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
To evaluate the effect of PPS on Patient Global Impression of Change (PGIC) in participants with knee OA pain 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".
Change from baseline of the parent study in Quality of Life (QoL) as assessed by Short Form-36 General Health Survey (SF-36) 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.
Change from baseline of the parent study in Work Productivity and Activity Impairment (WPAI) questionnaire. 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
To evaluate the real-world use of pain medications/therapies, following a single course of PPS Baseline up to Week 34 Number of days rescue medication used or use of other pain medications and therapies
To Evaluate the safety and tolerability of PPS is participants with knee OA pain Baseline up to Week 34 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.
Trial Locations
- Locations (2)
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
Emeritus Research
🇦🇺Camberwell, Victoria, Australia