NCT00548925已完成2 期
A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ABT-894 Versus Placebo in Subjects With Diabetic Neuropathic Pain
AbbVie (prior sponsor, Abbott)29 个研究点 分布在 7 个国家目标入组 124 人开始时间: 2007年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 29
- 主要终点
- Weekly mean of 24-hour average pain score
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of a 6 mg twice a day dose of an investigational product in subjects with diabetic neuropathy
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, age 18 to 75
- •If female, must be of non-childbearing potential or practicing birth control
- •Has diabetes mellitus (Type 1 or 2) and a diagnosis of painful distal symmetric diabetic polyneuropathy
- •Has had pain from distal symmetric diabetic polyneuropathy for a minimum of 6 months
- •Must be willing to washout of all analgesic medications prior to entry into the study
排除标准
- •Has other conditions that may cause pain
- •Currently receiving analgesic medications for conditions other than diabetic neuropathic pain
- •Has a history of certain psychiatric diseases
- •Has a history of certain heart or cardiovascular conditions
- •Has any clinically significant recent infection, injury, or illness
- •Current participation in another clinical study or participation within the past 30 days
- •Is incapacitated, bedridden or confined to a wheelchair
- •Is pregnant and/or breastfeeding
- •Previous participation in this study or any other study with this investigational product.
研究组 & 干预措施
1
Experimental
干预措施: ABT-894 (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Weekly mean of 24-hour average pain score
时间窗: Change from Baseline to final
次要结局
- Short-Form McGill Pain Questionnaire (SF-MPQ), Neuropathic Pain Scale (NPS)(8-week)
- Pain improvement from Baseline to the final evaluation(8-week)
- Weekly mean of 24-hour worst pain severity; weekly average night pain and morning pain(8-week)
- Global assessments of study drug and pain status(8-week)
研究者
研究点 (29)
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