A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Aptinyx
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Pain Intensity Numeric Rating Scale (NRS) Score
研究概览
简要总结
To evaluate the efficacy of NYX-2925 versus placebo in treating the neuropathic pain associated with diabetic peripheral neuropathy.
详细描述
This is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of NYX-2925 in subjects with neuropathic pain associated with diabetic peripheral neuropathy.
The study will be a 13- to 16-week study, including a 1- to 4-week Screening Period, followed by a 12- week double-blind, randomized, placebo-controlled Treatment Period.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Randomization algorithm, randomization allocation, allocation to study drug or placebo.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Pain due to other conditions or diseases that would complicate participation in the study or pain reporting
- •Current or historical serious medical conditions
- •Prior participation in NYX-2925 clinical trial
研究组 & 干预措施
NYX-2925
NYX-2925 50 mg
干预措施: NYX-2925 50 mg (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Pain Intensity Numeric Rating Scale (NRS) Score
时间窗: Week 12
Change from baseline in the weekly mean of the daily Numeric Rating Scale (NRS) score assessing average pain intensity related to DPN in the past 24 hours. In the NRS, a participant selects a whole number (0 to 10) that best indicates the intensity of his/her pain, where 0 represents no pain and 10 represents worst pain imaginable.
次要结局
- Daily Sleep Interference Scale (DSIS) Score(Week 12)
- Patient Global Impression of Change (PGI-C)(Week 12)
- Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN) Score(Week 12)
- Use of Rescue Medication(Week 12)
- Number of Subjects Achieving ≥30% Pain Reduction(Week 12)
- Number of Subjects Achieving ≥50% Reduction(Week 12)