NCT00647231已完成2 期
Protocol HKT-500-US12: A Randomized, Multicenter, Double-Blind, Single Dose Study of the Analgesic Properties of HKT-500 and Placebo in Subjects With Pain Caused by Mild to Moderate Osteoarthritis of the Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Time to Onset and Duration
研究概览
简要总结
The objective of this study is to characterize the analgesic properties of single dose study of HKT-500 in subjects with pain caused by mild to moderate OA of the knee
详细描述
A Randomized, Multicenter, Double-Blind, Single Dose Study of the Analgesic Properties of HKT-500 and Placebo in Subjects with Pain Caused by Mild to Moderate Osteoarthritis of the Knee
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female 45 years of age or older
- •with osteoarthritis of the knee
排除标准
- •subject is a woman of childbearing potential
- •who has a positive urine pregnancy test,
- •is lactating, or who is not surgically sterile
研究组 & 干预措施
A, 2, II, HKT-500 Topical Patch
Experimental
A Randomized, Multicenter, Double-Blind, Single Dose Study of the Analgesic Properties of HKT-500 and Placebo in Subjects With Pain Caused by Mild to Moderate Osteoarthritis of the Knee
干预措施: HKT-500 Topical Patch (Drug)
Placebo Patch
Placebo Comparator
Treatment with placebo patch
干预措施: Placebo Patch (Other)
结局指标
主要结局
Time to Onset and Duration
时间窗: 36 hours
次要结局
- Outcome Time Frame(36 hours)
研究者
研究点 (1)
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