A Four-Week Multicenter Study Evaluating the Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Subjects With Osteoarthritis of the Knee
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- The Primary Efficacy Endpoint of This Study is the Weekly Average Daily NPRS (Average Pain)
研究概览
简要总结
The purpose of this study is to assess the efficacy of a single dose level of gefapixant (AF-219/MK-7264) in subjects with moderate to severe pain associated with osteoarthritis (OA) of the knee compared with placebo after 4 weeks of treatment.
The study will also assess the safety and tolerability, changes in physical function, stiffness, treatment response and health outcomes.
详细描述
Subjects who satisfy entry criteria at Screening will enter the Washout Phase, discontinuing their current nonsteroidal anti-inflammatory drug (NSAID) therapy.
Up to 220 subjects who fulfill flare (and other entry) criteria will be randomized to gefapixant or placebo.
Subjects will complete Treatment Visits 1, 2, 3, and 4 weeks after starting study drug. At each Treatment Visit, subjects will undergo efficacy assessments and safety procedures. During the Washout and Treatment Phases subjects will complete the 'average pain' Numeric Pain Rating Scale (NPRS) and count of rescue medication used for the preceding 24 hours.
Subjects will return 2 weeks after their last Treatment Visit (for a Follow-Up Visit).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women
- •Women of child bearing potential must not be pregnant during the study and must use two forms of birth control
- •Men and their female partners must use two forms of birth control
- •Clinical and radiographic evidence of chronic knee osteoarthritis
- •An average NPRS score of >=5 and <=9 over a 4-7 day washout period of their previous osteoarthritis medications
- •Ambulatory
- •Have provided written informed consent
排除标准
- 未提供
研究组 & 干预措施
Sugar pill
干预措施: Sugar Pill (Drug)
Gefapixant
干预措施: Gefapixant (Drug)
结局指标
主要结局
The Primary Efficacy Endpoint of This Study is the Weekly Average Daily NPRS (Average Pain)
时间窗: 2 Weeks
Subjects were instructed to select a number on a scale that best described their knee arthritis pain during the past 24 hours. The scale was between 0 and 10 where 0 was no pain and 10 was the worst possible pain. The scale was completed by telephone (an interactive voice response system \[IVRS\]) every evening before bedtime.
次要结局
- WOMAC Scores(4 Weeks)
- SF-36(4 Weeks)