NCT02701374已完成2 期
TRK-700 An Early Phase II Study in Patients With Post-Herpetic Neuralgia -Double Blind Comparison With Placebo-
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Change in average Numerical Rating Scale (NRS)
研究概览
简要总结
In Post-Herpetic Neuralgia(PHN) patients:
- To conduct an explorative investigation of the efficacy and safety of repeated oral doses of TRK-700 via a randomized double blind comparative study
- To measure the plasma concentration of TRK-700 and its metabolites
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 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pain persisting for at least 3 months after the onset of herpes zoster
- •Patients whose average pain score on the Numerical Rating Scale (NRS) over the past 24 hours at preliminary enrollment is at least 4
排除标准
- •Patients with another skin disease that may affect the evaluation of the pain at the site of PHN
- •Patients with pain other than PHN that may affect the evaluation of pain
- •Patients with pain that is suspected to be mainly psychogenic
- •Patients who have received neurolytic or neurosurgical therapy for PHN
研究组 & 干预措施
1:TRK-700
Experimental
high dose
干预措施: TRK-700 (Drug)
2:TRK-700
Experimental
low dose
干预措施: TRK-700 (Drug)
3:Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in average Numerical Rating Scale (NRS)
时间窗: baseline to week 8
Change in average NRS collected by Pain Diary from baseline to week 8 in subjects receiving TRK-700 versus Placebo
次要结局
未报告次要终点
研究者
研究点 (1)
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