NCT00058968已完成3 期
Duloxetine Versus Placebo in the Treatment of Patients With Painful Diabetic Neuropathy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 660
- 试验地点
- 1
- 主要终点
- Reduction in average pain severity as measured by an 11-point Likert scale.
研究概览
简要总结
The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.
详细描述
The protocol will assess the efficacy and safety of duloxetine. It will also look at how duloxetine affects quality of life.
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
- None
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
- •Male or female outpatients at least 18 years of age.
- •Patients with pain due to diabetic neuropathy in both legs.
- •Females must not be pregnant or plan to become pregnant during the study.
- •Stable Glycemic control.
- •Average mean pain severity score of at least 4.0 as assessed by completion of a daily diary.
排除标准
- •You are related to or work for the physician conducting the study or are employed by Eli Lilly and Company.
- •You have a severe or serious medical condition that causes you to be hospitalized often; or you have had a kidney transplant or are on current dialysis.
- •You have participated in a study for an investigational drug within the last 30 days.
- •You have a history of major depressive disorder, generalized anxiety disorder, or alcohol or eating disorders.
- •You have a past medical history or diagnosis of mania, bipolar disorder, or psychosis.
结局指标
主要结局
Reduction in average pain severity as measured by an 11-point Likert scale.
次要结局
- Pain severity for worst pain and night pain as measured by an 11-point Likert scale.
- Clinical Global Impression of Severity scale to measure severity of illness at the time of assessment.
- Patient Global Impression of Improvement scale to measure the degree of improvement at the time of assessment.
- Brief Pain Inventory to measure the severity of pain.
- Sensory Portion of the Short Form McGill pain questionnaire measures severity of 11 pain descriptors.
- Hamilton Depression Rating Scale (17 item) used to assess severity of depression symptoms during the course of therapy.
- Dynamic Allodynia measure to elicit the pain severity to a normally non-painful stimulus.
研究者
研究点 (1)
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