NCT00838799已完成2 期
A Randomized, Double-Blind, Placebo- and Active-Controlled Study of the Safety and Efficacy of RGH-896 in Patients With Diabetic Peripheral Neuropathic Pain
Forest Laboratories1 个研究点 分布在 1 个国家目标入组 458 人开始时间: 2009年2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
- 458
- 试验地点
- 1
- 主要终点
- Change in mean daily pain rating
研究概览
简要总结
This study is designed to evaluate the safety and efficacy of RGH-896 in patients with diabetic peripheral neuropathic pain.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients 18 to 75 years of age
- •A diagnosis of painful diabetic neuropathy
- •Controlled blood glucose
- •Willingness to wash out all analgesic medications used for DPNP
- •Female patients either postmenopausal, surgically sterile, or practicing a medically acceptable method of contraception
- •Female patients who are not pregnant
排除标准
- •Acute infections or cardiac problems
- •Past use of pregabalin
- •History of severe psychiatric disorder
- •History of any amputation due to diabetes
- •History of seizure disorder
- •Active diabetic foot ulcers
研究组 & 干预措施
1
Experimental
干预措施: RGH-896 (Drug)
2
Experimental
干预措施: RGH-896 (Drug)
3
Experimental
干预措施: RGH-896 (Drug)
4
Active Comparator
干预措施: pregabalin (Drug)
5
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change in mean daily pain rating
时间窗: Baseline to Week 14
次要结局
- 50% reduction in pain(Baseline to Week 14)
研究者
研究点 (1)
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