NCT00576277已完成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
Avigen2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2006年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of AV411 after single and multiple doses in patients with chronic neuropathic pain due to diabetes.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 <100,000mm3 or a history of thrombocytopenia
- •Known or suspected chronic liver disease
- •GFR <=90mL/min/1.73m2 (Cockcroft-Gault)
- •Female subjects who are pregnant or nursing mothers
- •Received an investigational drug in the past 90 days
- •Unable to swallow large capsules
结局指标
主要结局
Safety
Tolerability
Pharmacokinetic profile
Pharmacodynamic profile
次要结局
- Brief Pain Inventory
- Visual Analog Scale
- Clinical Global Impression of Change
- Use of analgesic or adjuvant medications for neuropathic pain
- Correlation between plasma concentrations of AV411 and pain intensity assessments
研究者
研究点 (2)
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