NCT00044395已完成3 期
LY333531 Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 39
- 主要终点
- Reduction in neuropathic symptoms
研究概览
简要总结
The purpose of this protocol is to determine if an investigational drug is effective in treating nerve malfunction in 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have type I or type II Diabetes Mellitus.
- •Have clinically diagnosed positive sensory symptoms such as numbness, lancinating pain, burning pain, aching pain, allodynia and prickling sensation that have been present not greater than 5 years but stable for 6 months.
- •Has a HbA1C less than or equal to 12%. Patients with HbA1C greater than 9% must be on insulin therapy.
- •Must be 18 years or older.
- •Be able to visit the doctor's office approximately 3 times over a maximum of a 6-week period to determine if you can continue in the study.
排除标准
- •History of significant liver problems.
- •Have poor kidney function.
- •Drink an excess of alcohol or abuse drugs.
- •Have recently participated or currently participating in a Medical study in which you receive an experimental drug.
- •Are a woman and are pregnant or breastfeeding, intend to become pregnant within the next 2 years or a woman not using effective birth control.
结局指标
主要结局
Reduction in neuropathic symptoms
次要结局
- Vibration sensation;Neurological signs;Electrophysiology of peroneal, tibial and sural nerves;Relief of symptoms as measured by VAS;Composite scores of nerve function;Clinical global impression of change
研究者
研究点 (39)
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