A 4-week, Randomized, Double-blind, Multicenter, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis (OA) of the Knee
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 289
- 试验地点
- 1
- 主要终点
- Evaluate Efficacy & Safety of HP-5000 Topical Patches in Subjects With Osteoarthritis of the Knee: Change in Osteoarthritis Pain Score
研究概览
简要总结
A 4-week, Randomized, Double-blind, Multicenter, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects with Osteoarthritis (OA) of the Knee
详细描述
This is a multicenter, randomized, double-blind, and placebo-controlled phase 2 study evaluating 2 formulations of HP-5000 in subjects with OA of the knee. The study will consist of up to 28-day Screening Phase that will include a Washout Period of current prescription and over the counter (OTC) analgesics, a 4-week double-blind Treatment Phase, and a 1-week safety Follow-up Period.
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 (ACR) criteria, including:
- •Symptoms for at least 6 months prior to screening, AND
- •Knee pain in the target knee for 30 days of the preceding month (periarticular knee pain due to OA and not due to other conditions such as bursitis, tendonitis, etc.) AND
- •The pain in the target knee required the use of nonsteroidal anti-inflammatory drugs (NSAIDs) either over the counter (OTC) per recommendation of a physician or prescribed.
排除标准
- •Body mass index (BMI) > 40
- •Any subject who disobeyed the restriction of prohibited therapies (i.e., use rescue medication) during Screening Washout Period.
- •Secondary OA of the knee (rheumatoid arthritis, gout, psoriasis, syphilitic neuropathy, ochronosis, metabolic or other primary bone disease or acute trauma).
研究组 & 干预措施
Diclofenac Sodium Active Topical Patch 1
Diclofenac sodium 1 topical patches will be compared against placebo patches.
干预措施: Diclofenac Sodium Active Topical Patch 1 (Drug)
Diclofenac Sodium Active Topical Patch 1
Diclofenac sodium 1 topical patches will be compared against placebo patches.
干预措施: Placebo patch (Drug)
Diclofenac Sodium Active Topical Patch 2
Diclofenac sodium 2 topical patches will be compared against placebo patches.
干预措施: Diclofenac Sodium Active Topical Patch 2 (Drug)
Diclofenac Sodium Active Topical Patch 2
Diclofenac sodium 2 topical patches will be compared against placebo patches.
干预措施: Placebo patch (Drug)
结局指标
主要结局
Evaluate Efficacy & Safety of HP-5000 Topical Patches in Subjects With Osteoarthritis of the Knee: Change in Osteoarthritis Pain Score
时间窗: Baseline and 4 weeks
To evaluate efficacy of HP-5000 Active Topical Patch 1 and HP-5000 Active Topical Patch 2 compared with placebo for the 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 4. 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 range from 0 to 20 with a low score considered a better outcome and a high score considered a worse outcome.
次要结局
- WOMAC Stiffness Score Change From Baseline(Baseline and 4 weeks)
- WOMAC Physical Function Score(Baseline and 4 weeks)
- WOMAC Pain Score Week 2 Change From Baseline(Baseline and 2 weeks)