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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 2
- 主要终点
- Assess duration of treatment effect of PPS in participants with OA pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Pentosan Polysulfate Sodium
Pentosan Polysulfate Sodium (PPS) at Dose and frequency selected in Stage 1 of Parent Study for 6 weeks
干预措施: Pentosan Polysulphate Sodium (Drug)
Placebo
Placebo for 6 weeks
干预措施: Placebo (Sodium Chloride Injection, 0.9%) (Drug)
结局指标
主要结局
Assess duration of treatment effect of PPS in participants with OA pain
时间窗: 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.
次要结局
- 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)
- Assess duration of treatment effect of PPS in participants with OA pain(Week 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)
- Assess efficacy of PPS treatment on knee pain in participants with knee OA pain(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(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)
- 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)
- Assess real-world use of pain medications/therapies, following a single course of PPS(Baseline up to Week 34)
- Incidence of treatment-emergent AE's, SAE's and AESI of PPS is participants with knee OA pain(Baseline up to Week 34)
- 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)