A Randomized, Double-Blind, Parallel, Multi-Center, Phase 2 Clinical Trial to Determine the Optimal Dose of AD-211 in Patients With Osteoarthritis of the Knee
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Change from baseline in 100 mm Pain VAS score during activity over the past 24 hours in the target knee
研究概览
简要总结
The purpose of this study is to determine the optimal dose of AD-211 in patients with osteoarthritis of the knee.
详细描述
Osteoarthritis of the knee
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Patients with osteoarthritis of the Knee
- •Other inclusions applied
排除标准
- •Patients with secondary osteoarthritis of the knee
- •Other exclusions applied
研究组 & 干预措施
AD-211-L Group
1 Week: twice daily; 2 tablets per dose (AD-211-L + placebo to AD-2113). 12 Weeks: twice daily; 3 tablets per dose (AD-211-L + placebo to AD-211-H + placebo to AD-2113).
干预措施: AD-211-L (Drug)
AD-211-L Group
1 Week: twice daily; 2 tablets per dose (AD-211-L + placebo to AD-2113). 12 Weeks: twice daily; 3 tablets per dose (AD-211-L + placebo to AD-211-H + placebo to AD-2113).
干预措施: Placebo to AD-211-H (Drug)
AD-211-L Group
1 Week: twice daily; 2 tablets per dose (AD-211-L + placebo to AD-2113). 12 Weeks: twice daily; 3 tablets per dose (AD-211-L + placebo to AD-211-H + placebo to AD-2113).
干预措施: Placebo to AD-2113 (Drug)
AD-211-M Group
1 Week: twice daily; 2 tablets per dose AD-211-M + placebo to AD-2113). 12 Weeks: twice daily; 3 tablets per dose (AD-211-M + placebo to AD-211-H + placebo to AD-2113).
干预措施: AD-211-M (Drug)
AD-211-M Group
1 Week: twice daily; 2 tablets per dose AD-211-M + placebo to AD-2113). 12 Weeks: twice daily; 3 tablets per dose (AD-211-M + placebo to AD-211-H + placebo to AD-2113).
干预措施: Placebo to AD-211-H (Drug)
AD-211-M Group
1 Week: twice daily; 2 tablets per dose AD-211-M + placebo to AD-2113). 12 Weeks: twice daily; 3 tablets per dose (AD-211-M + placebo to AD-211-H + placebo to AD-2113).
干预措施: Placebo to AD-2113 (Drug)
AD-211-H Group
1 Week: twice daily; 2 tablets per dose (AD-211-M + placebo to AD-2113). 12 Weeks: twice daily; 3 tablets per dose (AD-211-H + placebo to AD-211-L/M + placebo to AD-2113).
干预措施: AD-211-M (Drug)
AD-211-H Group
1 Week: twice daily; 2 tablets per dose (AD-211-M + placebo to AD-2113). 12 Weeks: twice daily; 3 tablets per dose (AD-211-H + placebo to AD-211-L/M + placebo to AD-2113).
干预措施: AD-211-H (Drug)
AD-211-H Group
1 Week: twice daily; 2 tablets per dose (AD-211-M + placebo to AD-2113). 12 Weeks: twice daily; 3 tablets per dose (AD-211-H + placebo to AD-211-L/M + placebo to AD-2113).
干预措施: Placebo to AD-211-L/M (Drug)
AD-211-H Group
1 Week: twice daily; 2 tablets per dose (AD-211-M + placebo to AD-2113). 12 Weeks: twice daily; 3 tablets per dose (AD-211-H + placebo to AD-211-L/M + placebo to AD-2113).
干预措施: Placebo to AD-2113 (Drug)
AD-2113 Group
1 Week: twice daily; 2 tablets per dose (AD-2113 + placebo to AD-211-L/M). 12 Weeks: twice daily; 3 tablets per dose (AD-2113 + placebo to AD-211-L/M + placebo to AD-211-H).
干预措施: AD-2113 (Drug)
AD-2113 Group
1 Week: twice daily; 2 tablets per dose (AD-2113 + placebo to AD-211-L/M). 12 Weeks: twice daily; 3 tablets per dose (AD-2113 + placebo to AD-211-L/M + placebo to AD-211-H).
干预措施: Placebo to AD-211-L/M (Drug)
AD-2113 Group
1 Week: twice daily; 2 tablets per dose (AD-2113 + placebo to AD-211-L/M). 12 Weeks: twice daily; 3 tablets per dose (AD-2113 + placebo to AD-211-L/M + placebo to AD-211-H).
干预措施: Placebo to AD-211-H (Drug)
结局指标
主要结局
Change from baseline in 100 mm Pain VAS score during activity over the past 24 hours in the target knee
时间窗: Baseline to Week13
次要结局
未报告次要终点