NCT04858659Unknown3 期
A Multi-center, Randomized, Double-blind, Active-controlled, Parallel-designed, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of PK101 Compared With PK101-002 in Patients With Knee Osteoarthritis
PMG Pharm Co., Ltd1 个研究点 分布在 1 个国家目标入组 354 人开始时间: 2021年5月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 354
- 试验地点
- 1
- 主要终点
- Change during activity in 100mm Pain VAS
研究概览
简要总结
The purpose of this study is to compare the efficacy and the safety of PK101 in patients with knee osteoarthritis.
详细描述
The primary purpose of this study is to evaluate the efficacy of PK101 compared with PK101-002 at Week 8 in osteoarthritis. Also evaluates the safety of PK101.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥40 and of age
- •Patients who meets the American College Rheumatology (ACR) criteria and has lasted for at least three months after diagnosis of one-sided or bilateral knee osteoarthritis.
- •Radiographic evidence of grade 1 ~ 3 osteoarthritis based on the Kellgren & Lawrence radiographic entry criteria at visit 1
- •Score of 100mm pain VAS ≤ 80mm at visit 1
- •Written consent form voluntarily
- •Score of 100mm pain VAS ≥ 40mm at visit 3
- •Patients with an individual medication compliance of 70% or more of the IP administered during the Run-in period
排除标准
- •Patients who has a history of hypersensitivity to components of IP, NSAIDs including COX-2 inhibitors, a history of hypersensitivity to aspirin, or allergic reactions to sulfonamides
- •Patients with inflammatory, infectious, metabolic, septic arthritis or rheumatoid arthritis other than osteoarthritis
- •Patients with a condition that can affect the joints
- •Patients who have undergone arthroscopic surgery within 1 year , knee joint surgery within 5 years, synoviorthesis within 3 months prior to visit 1 to the target knee, or who have planned surgery during the trial period
- •Patients who have used corticosteroids as follows:
- •Inj. of corticosteroid, including intraarticular administration, into the target knee within 3 months prior to visit 1
- •Oral corticosteroid administration within 1 month prior to visit 1
- •Patients who have intraarticular injected hyaluronic acid or cell therapy products, gene therapy products, etc. for the treatment of osteoarthritis within 3 months prior to visit 1
研究组 & 干预措施
PK101 group
Experimental
干预措施: PK101 (Drug)
PK101 group
Experimental
干预措施: PK101-002 placebo (Drug)
PK101-002 group
Active Comparator
干预措施: PK101-002 (Drug)
PK101-002 group
Active Comparator
干预措施: PK101 placebo (Drug)
结局指标
主要结局
Change during activity in 100mm Pain VAS
时间窗: baseline through week 8
Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever
次要结局
- Change in WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index using the Visual Analogue Scale, Version 3.1) sub scale & total score(baseline through week 4, 8)
- Change during activity in 100mm Pain VAS(baseline through week 4)
- Change in PGA(baseline through week 8)
- Change in SF-36 sub scale & PCS, MCS as measured by Health Survey(Short Form, SF-36 v2, Physical Component Summary, Mental Component Summary)(baseline through week 8)
- Change at rest in 100mm Pain VAS(baseline through week 4, 8)
研究者
研究点 (1)
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