NCT02759198已完成2 期
A Randomized, Double-blind, Placebo- and Active-Controlled, Multicenter, Phase 2 Trial to Evaluate the Efficacy and Safety of YH23537 in Patients With Osteoarthritis of the Knee
Yuhan Corporation1 个研究点 分布在 1 个国家目标入组 456 人开始时间: 2016年5月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 456
- 试验地点
- 1
- 主要终点
- Change From Baseline in VAS score to assess pain at Week 12
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of YH23537 versus celebrex in patients with knee osteoarthritis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent
- •Men and women ≥ 40 years of age
- •Patients with knee osteoarthritis at one or both knee by ACR
排除标准
- •Patients with known or suspected secondary knee osteoarthritis
- •Other exclusions applied
研究组 & 干预措施
YH23537
Experimental
YH23537 750/1500/3000mg
干预措施: YH23537 (Drug)
Celebrex
Active Comparator
Celecoxib 200mg
干预措施: Celecoxib (Drug)
Placebo
Placebo Comparator
YH23537 Placebo
干预措施: YH23537 placebo (Drug)
结局指标
主要结局
Change From Baseline in VAS score to assess pain at Week 12
时间窗: baseline and week 12
次要结局
- Change From Baseline in WOMAC subgroup(pain, stiffness, difficulty performing daily activities) score at Week 4, 8, 12(baseline, week 4, week 8 and week 12)
- Percentage From Baseline in WOMAC responder at Week 4, 8, 12(baseline, week 4, week 8 and week 12)
- Change From Baseline in VAS score to assess pain at Week 4, 8(baseline, week 4 and week 8)
- Percentage of positive response(excellent, good and fair response) in Physician's Global Assessment of Response to Therapy (PGART) at Week 12(week 12)
- Change From Baseline in Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) score at Week 4, 8, 12(baseline, week 4, week 8 and week 12)
- Percentage of positive response(+1) in Patient Global Impression of Change (PGIC) at Week 12(week 12)
研究者
研究点 (1)
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