NCT00625833终止2 期
A Randomized, Double-Blind Placebo Controlled Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Change from baseline in weekly average pain score
研究概览
简要总结
This is a trial to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving chronic peripheral pain suffered by patients with diabetes. Some evidence for the effectiveness of [S,S]- Reboxetine in relieving chronic pain has been seen in 3 completed trials.
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 (Participant, Investigator)
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 of any race at least 18 years of age
- •Diagnosis of painful, distal, symmetrical, sensory-motor polyneuropathy, which is due to diabetes, for at least 1 year
- •Patients at Visit 1 must have a score ≥40 mm on the Pain Visual Analogue Scale
排除标准
- •Patients with significant hepatic impairment
- •Neurological disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathic pain
- •Any pain or other condition that may confound assessment or self-evaluation of the pain due to diabetic neuropathy
- •Amputations other than toes
- •A current or recent diagnosis (past 6 months) or episode of major depressive disorder and/or uncontrolled depression
- •History of transient ischemic attack or stroke
- •Myocardial infarction or unstable angina within the past three months
研究组 & 干预措施
2
Experimental
干预措施: [S,S]-Reboxetine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in weekly average pain score
时间窗: 8 weeks
次要结局
- Change from baseline in weekly average sleep interference scale(8 weeks)
- Change from baseline in the total score and each dimension of the Neuropathic Pain Symptom Inventory(8 weeks)
- Responder rates (patients with a 30% reduction from baseline in weekly average pain score and patients with a 50% reduction from baseline in weekly average pain score)(8 weeks)
- Modified Brief Pain Inventory-Short Form(8 weeks)
研究者
研究点 (1)
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