NCT01544296已完成2 期
Phase II Study of KHK6188 (A Placebo-controlled, Double Blind, Crossover Study of KHK6188 in Postherpetic Neuralgia)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change of pain intensity score
研究概览
简要总结
This is a placebo-controlled, double blind, crossover study to evaluate the efficacy and safety of KHK6188 in postherpetic neuralgia when administered orally for 2 weeks.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pain for ≥ 3 months and ≤ 1 year following onset of a herpes zoster rash
- •Patients with a mean pain intensity score (11-point numerical rating scale) of ≥ 4
- •Patients whose rash has been healed
- •Patients who are able to fill their patient diary
- •Patients who provided written voluntary informed consent to participate in the study
排除标准
- •Patients who have other pain or disease which may impair the self assessment of pain
- •Patients who have dementia, depression or schizophrenia which may affect the self assessment of pain
- •History or presence of severe cardiovascular disease, hepatic dysfunction, renal failure, respiratory disease, blood disease or CNS disorder
- •History or presence of a drug allergy
- •Patients who have a history of a diagnosis of cancer or a treatment of cancer within 5 years prior to the study entry
- •Patients received an investigational medication within 4 months (6 months for biologic medication such as antibody) prior to the informed consent
- •Women of child bearing potential who do not agree to avoid pregnancy from the time of providing the consent until 3 months after the end of dosing, or men of reproductive potential who do not agree to avoid pregnancy from the time of the first dose until 3 months after the end of dosing
- •Patients who are pregnant, lactating, or possibly pregnant
- •Patients judged to be inappropriate to enter the study by a investigator or a subinvestigator
研究组 & 干预措施
KHK6188, high dose
Experimental
干预措施: KHK6188 (Drug)
KHK6188, low dose
Experimental
干预措施: KHK6188 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change of pain intensity score
时间窗: baseline and 2weeks
次要结局
- Change of allodynia severity(baseline and 2 weeks)
- Change of global impression(baseline and 2 weeks)
研究者
研究点 (1)
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