2022-500228-31-01
已完成
2/3 期
A 2-stage, Adaptive, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Evaluate Dose and Treatment Effect of Pentosan Polysulfate Sodium Compared with Placebo in Participants with Knee Osteoarthritis Pain
概览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- Change from baseline at Day 56 in knee pain as assessed by the average pain subscale score of the Western Ontario and McMaster Universities (Osteoarthritis Index) (WOMAC®) Numeric Rating Scale (NRS) 3.1 Index.
概览
简要总结
To evaluate the treatment effect of PPS on knee pain and function in participants with knee OA pain.
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment stage 2
- 盲法
- Double (Analyst, Investigator, Monitor, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Male and Female Participants 18 years of age or older
- •Clinical diagnosis of OA in the index knee by American College of Rheumatology 1986 criteria.
- •Radiographic diagnosis (confirmed by radiologist) of knee OA classified K-L Grade 2, 3, or 4 on standing anterior-posterior X-ray of the index knee.
- •Osteoarthritis pain in the index knee unresponsive to conservative therapy for ≥6 months preceding Screening
- •Average WOMAC® NRS 3.1 Index pain subscale score of 4 to 10 in the index knee at Screening AND a minimum pain score of 4 on either of the individual questions of pain on walking on a flat surface or pain on climbing stairs at Screening.
- •Average WOMAC® NRS 3.1 Index function subscale score of 4 to 10 in the index knee at Screening.
- •Body mass index of ≥18.0 to ≤39.0 kg/m2
- •Willing to stop treatment with oral and topical NSAIDs, and all other systemic pain medications (except acetaminophen/paracetamol per rescue protocol) from 2 weeks before Day 1 to end of study.
排除标准
- •Documented or reported history of increased bleeding in the absence of anticoagulant or antiplatelet drugs or prior history of major bleeding episode in the presence of anticoagulant or antiplatelet therapy.
- •Chronic medical conditions including but not limited to those stated below requiring medical regime changes within 60 days before Day
- •Concurrent unstable peripheral, cardiac, and cerebral vascular disease, poorly controlled chronic obstructive pulmonary disease and asthma, coagulopathies, uncontrolled neurological conditions, active tuberculosis, active infections, symptomatic cardiac arrhythmias, adrenal insufficiency (primary or central), nephrotic syndrome, Cirrhosis (Child-Pugh stage B or C), Gilberts syndrome, uncontrolled diabetes and uncontrolled hypothyroidism or hyperthyroidism, or mental or emotional disorders that preclude reliable study participation.
- •Current treatment with anticoagulants or antiplatelet drugs, excluding aspirin ≤100 mg/day.
- •Previous treatment with PPS in any form.
- •Known exposure to heparin within the last 100 days as determined by history of drug use or history of the following medical conditions or interventions: cardiac bypass surgery or thromboembolic disease
- •Any clinically significant abnormalities on clinical chemistry, haematology, urinalysis, physical examination, medical history, 12-lead ECG, or vital signs as judged by the Investigator (at Screening).
- •Major surgery or anticipated surgery during the study.
- •History of idiopathic or immune-mediated thrombocytopenia including history of or laboratory confirmed HIT (positive or equivocal antibodies against platelet factor 4 [ie, PF4] and positive Serotonin Release Assay [SRA]).
- •Currently active or recent history (within preceding 12 months) of a gastric or duodenal ulcer, or suspicion of gastrointestinal tract bleeding.
结局指标
主要结局
Change from baseline at Day 56 in knee pain as assessed by the average pain subscale score of the Western Ontario and McMaster Universities (Osteoarthritis Index) (WOMAC®) Numeric Rating Scale (NRS) 3.1 Index.
Change from baseline at Day 56 in knee pain as assessed by the average pain subscale score of the Western Ontario and McMaster Universities (Osteoarthritis Index) (WOMAC®) Numeric Rating Scale (NRS) 3.1 Index.
Change from baseline at Day 56 in function as assessed by the average functional subscale score of the WOMAC® NRS 3.1 Index for EMA/MHRA, function will be included as a co-primary endpoint, but still tested in hierarchical order).
Change from baseline at Day 56 in function as assessed by the average functional subscale score of the WOMAC® NRS 3.1 Index for EMA/MHRA, function will be included as a co-primary endpoint, but still tested in hierarchical order).
次要结局
- Change from baseline at Day 56 in function as assessed by the average functional subscale score of the WOMAC® NRS 3.1 Index for EMA/MHRA, function will be included as a co-primary endpoint, but still tested in hierarchical order).Function will be a key secondary in the United States
- Change from baseline at Day 84 in knee pain as assessed by the average pain subscale score of the WOMAC® NRS 3.1 Index.
- Change from baseline at Day 84 in function as assessed by the average functional subscale score of the WOMAC® NRS 3.1 Index.
研究者
Director of Clinical Operations
Scientific
Paradigm Biopharmaceuticals (USA) Inc.
研究点 (6)
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