NCT00683423已完成2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Trial to Evaluate the Efficacy and Safety of BMS-741672 in Patients With Diabetic Neuropathic Pain
Bristol-Myers Squibb8 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2008年7月最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- Reduction in weekly average pain score for BMS drug vs. placebo, computed from diary scores
研究概览
简要总结
The purpose of the study is to determine whether BMS-741672 improves neuropathic pain in diabetic patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 or 2 diabetics with painful, distal, symmetrical, sensory-motor neuropathy attributed to diabetes, of at least 12 months duration
- •Screening HbA1c of ≥ 7% and ≤ 10%
- •BMI ≤ 40 kg/m2
排除标准
- •Patients with clinically significant, progressive, or potentially unstable disease of any body system including cardiovascular, gastrointestinal, central nervous system (CNS), psychiatric, endocrine (other than diabetes), tuberculosis or renal
- •Women of childbearing potential
研究组 & 干预措施
B
Placebo Comparator
干预措施: Placebo (Drug)
A
Experimental
干预措施: BMS-741672 (Drug)
结局指标
主要结局
Reduction in weekly average pain score for BMS drug vs. placebo, computed from diary scores
时间窗: recorded during the last 7 days of treatment in each period
次要结局
- Other glycemic, vascular, and mechanism-based biomarkers will be measured(throughout the study)
研究者
研究点 (8)
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