NCT00837941撤回2 期
Qualification of Single Dose Administration of Analgesic Therapy in the Treatment of Chronic Neuropathic Pain in Patients With Painful Diabetic Neuropathy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- analgesic efficacy measured by patients self reported pain level after single dose administration
研究概览
简要总结
The purpose of this study is to determine if analgesic efficacy can be detected with single dose administration in patients with chronic neuropathic pain due to painful diabetic neuropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has been treated for type 1 or 2 diabetes mellitus with glycosylated hemoglobin
- •Patient has pain in both feet that occurred after onset of diabetes
- •Patient agrees to maintain a consistent activity level throughout the study
- •Patient is not on chronic pain therapy, or is on a stable dose of one pain therapy
- •Female patients of reproductive potential must agree to use two acceptable methods of birth control through out the study
- •Patients taking a pain medication must be on a stable dose at least 1 month prior to participating in study
排除标准
- •Patient has a history of congestive heart failure
- •Patient has/had a seizure disorder
- •Patient has tried and failed 3 or more drugs to treat neuropathic pain
- •Patient is currently taking pregabalin or duloxetine hydrochloride
- •Patient has had a malignancy within the past 2 years (excluding basal cell carcinoma)
- •Patient has history of hepatitis B or C or HIV infection
- •Patient has skin-condition that may decrease sensitivity in area of neuropathic pain
结局指标
主要结局
analgesic efficacy measured by patients self reported pain level after single dose administration
时间窗: 5-11 hours after single dose is administered
次要结局
- The onset of analgesic efficacy following single dose of pregabalin and duloxetine hydrochloride versus placebo(24 hours after single dose is administered)
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