2024-513435-24-01已完成2 期
J4F-MC-CYAB: A Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Finding Study Evaluating LY3848575 in Chronic Neuropathic Pain Associated With Distal Sensory Polyneuropathy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 13
- 主要终点
- Mean Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS)
研究概览
简要总结
To demonstrate that at least 1 dose of LY3848575 is superior to placebo in pain intensity
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Are at least 18 years or older old at time of ICF signature.
- •Have moderate to severe pain nerve pain at least 6 months prior to screening.
- •Are willing to discontinue all medications taken for chronic pain conditions.
- •Not be able to become pregnant.
排除标准
- •Have other sources of pain that interfere with assessing nerve pain
- •Have uncontrolled diabetes.
- •Have a surgery planned.
- •Have had chemotherapy for cancer in the last year that led to nerve pain
- •Have history within 2 years of study entry of alcohol or substance use disorder
研究组 & 干预措施
Placebo to match LY3848575
Placebo
干预措施: Placebo to match LY3848575 (Drug)
结局指标
主要结局
Mean Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS)
Mean Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS)
次要结局
未报告次要终点
研究者
Lilly Clinical Trials information desk
Scientific
Eli Lilly & Co.
研究点 (13)
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