NCT01557010已完成2 期
The Clinical Trial for Evaluation of Efficacy and Safety of DWP05195 in Postherpetic Neuralgia: Double-blind, Placebo-controlled, Randomized, Multi-center, Exploratory Clinical Trial
Daewoong Pharmaceutical Co. LTD.0 个研究点目标入组 140 人开始时间: 2012年3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
- 140
- 主要终点
- Endpoint change from the baseline after administered 8 weeks mean pain score based on the Numerical pain Rating Scale(NPRS) from the subject's daily pain diary
研究概览
简要总结
The purpose of this study is to evaluate efficacy, safety of administered DWP05195 in Postherpetic Neuralgia.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female subjects aged 20 to 80 years
- •Subjects with symptoms of neuropathic pain associated with postherpetic neuralgia(PHN).
- •Subjects must have pain present for > 3 months after healing of the acute herpes zoster skin rash.
排除标准
- •Other severe pain that may potentially confound pain assessment.
- •Subjects with symptoms of neuropathic pain applied Medical Equipment
- •Within 2 years: Subjects were diagnosed with cancer
研究组 & 干预措施
Treatment B
Experimental
干预措施: DWP05195 (Drug)
Treatment C
Experimental
干预措施: DWP05195 (Drug)
Treatment A
Experimental
干预措施: DWP05195 (Drug)
Treatment D
Placebo Comparator
干预措施: Control (Drug)
结局指标
主要结局
Endpoint change from the baseline after administered 8 weeks mean pain score based on the Numerical pain Rating Scale(NPRS) from the subject's daily pain diary
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
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