NCT00381719已完成2 期
Safety and Efficacy of AGN 203818 in Patients With 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
- 已完成
- 发起方
- Allergan
- 入组人数
- 330
- 主要终点
- Reduction in Daily Pain Score
研究概览
简要总结
This study will explore the safety and effectiveness of different doses of AGN 203818 in treating pain in patients with painful diabetic peripheral 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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Diagnosis of diabetic peripheral neuropathy
- •Moderate to severe neuropathic pain
排除标准
- •Any other uncontrolled disease
- •Pregnant or nursing females
研究组 & 干预措施
1
Experimental
3 mg
干预措施: AGN 203818 (Drug)
2
Experimental
20 mg
干预措施: AGN 203818 (Drug)
3
Experimental
60 mg
干预措施: AGN 203818 (Drug)
4
Placebo Comparator
Placebo
干预措施: placebo capsule (Drug)
结局指标
主要结局
Reduction in Daily Pain Score
时间窗: 1 Month
次要结局
- Changes in sleep interference score(Week 4)
- Beck depression inventory(Week 4)
- Quality of Life questionnaires(Week 4)
研究者
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