A 12-Week, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of HP-5000 Topical System (Patch) in Subjects With Osteoarthritis Pain of the Knee
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 370
- 试验地点
- 10
- 主要终点
- Change From Baseline to Week 12 in WOMAC Pain Score (Intent-to-treat Set)
研究概览
简要总结
A 12-week, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 3 study to Evaluate the Efficacy and Safety of HP-5000 in Subjects with Osteoarthritis (OA) Pain of the Knee
详细描述
This is a multi-center, randomized, double-blind, and placebo-controlled phase 3 study evaluating the safety and efficacy of HP-5000 in subjects with OA pain of the knees. The study will consist of up to a 28-day Screening Phase that will include a Washout Period of current prescription and over the counter (OTC) analgesics; a 12-week Double-blind Treatment Phase, and a 1-week safety Follow-up Phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 40 to 85 years with a clinical diagnosis of OA of the target knee according to the American College of Rheumatology criteria.
- •Has an X-ray of the target knee, taken no more than 1 year before Baseline, showing evidence of OA.
- •Has pain of OA in the designated/target study knee.
排除标准
- •Body mass index (BMI) >
- •Any subject who did not follow the restriction of prohibited therapies during Washout period.
- •Arthritis of the target knee that is not caused by OA but caused by diseases such as rheumatoid arthritis, gout, psoriasis, syphilitic arthropathy, ochronosis, metabolic or other primary bone disease, or acute traumatic injury.
研究组 & 干预措施
HP-5000 Treatment
HP-5000 Topical Patch will be evaluated against placebo topical patches.
干预措施: Diclofenac sodium active topical patch (Drug)
Placebo Treatment
Placebo patches without diclofenac sodium will be used.
干预措施: Placebo patch (Drug)
结局指标
主要结局
Change From Baseline to Week 12 in WOMAC Pain Score (Intent-to-treat Set)
时间窗: Baseline and 12-week
To evaluate efficacy of HP-5000 patch treatment compared with HP-5000 placebo patch treatment of Osteoarthritis of the knee as evaluated by change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to week 12. WOMAC pain score is a scale that evaluate five items including walking, stair climbing, nocturnal, rest and weight bearing. Each item is rated on a scale of 0 to 4, with 0 being no difficulty and 4 being extremely difficulty. The total score is the sum of five items. The total score ranges from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome.
次要结局
- Change From Baseline to Week 12 in WOMAC Stiffness Score(12 weeks)
- WOMAC Physical Function Change From Baseline at Week 12(Baseline and 12 weeks)