NCT00190970已完成2 期
The Effect of Ruboxistaurin Mesylate (LY333531) on Small Fiber Function as Measured by Microvascular Skin Blood Flow, C-Fiber Quantitations in Skin and Quantitative Sensory Testing of Cold and Heat.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- The objectives of this study is to evaluate the effect of ruboxistaurin on subjects with diabetic peripheral polyneuropathy
研究概览
简要总结
To determine the effect of Ruboxistaurin on small fiber function.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have Type 1 or Type 2 diabetes mellitus
- •Patients must have bilateral sensorimotor distal peripheral neuropathy attributable to diabetes mellitus
- •Patients must have blood glucose control measured as HbA1c=<11%
- •Patients must be 18 years of age or older.
- •Patients must be able to return to all follow-up visits
排除标准
- •Patients must not have symptoms of diabetic peripheral neuropathy that cannot be distinguished from other etiologies
- •Patients must not have a neurologic disease or neuropathy from a cause other than diabetes mellitus that would interfere with correct evaluation of symptomatic peripheral neuropathy.
- •Patient currently has uncontrolled high blood pressure
- •You have other medical problems that your doctor feels would make it unsafe for you to participate in this study such as liver or kidney problems
- •You are a woman of childbearing age and unwilling or unable to use effective contraceptive.
结局指标
主要结局
The objectives of this study is to evaluate the effect of ruboxistaurin on subjects with diabetic peripheral polyneuropathy
次要结局
- Ruboxistaurin will improve quantitative sensory testing and increase nerve fiber density in subjects with diabetic peripheral polyneuropathy.
研究者
研究点 (1)
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