ACTRN12606000403538招募中1 期
A prospective, double-blind, randomized, placebo-controlled trial of AV411 to assess its safety tolerability, pharmacokinetics and preliminary efficacy in the treatment of neuropathic pain
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Avigen, Inc.
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Diagnosis of diabetic neuropathy or complex regional pain syndrome of at least 6 months duration.-VAS score of 4 cm or higher at screening.-No clinical abnormality in laboratory and urine analyses.-Electrocardiogram within normal limits at screening.-Negative pregnancy test on Study Day 1 for female subjects of childbearing potential.-On stable doses of medications, analgesic or others for at least 8 weeks prior to study enrollment.-Willing to use barrier contraceptive during the period of the study.
排除标准
- •Known hypersensitivity to AV411 or its components.-Conditions which might affect drug absorption, metabolism or excretion.-Untreated mental illness, current drug addiction or abuse or alcoholism.-Donated blood in the past 90 days or have poor peripheral venous access.-Platelets <100,000 mm3 or a history of thrombocytopenia.-Known or suspected chronic liver disease.-GFR <= 90 mL/min/1.73m2 (Cockcroft-Gualt).-Female subjects who are pregnant or nursing mothers.-Received an investigational drug in the past 90 days.-Unable to swallow large capsules.
研究者
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