NCT00976534终止2 期
A Phase IIa Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Study Evaluating the Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 After 3 Weeks of Treatment in Patients With Posttraumatic Neuralgia (PTN) and Postherpetic Neuralgia (PHN)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change from baseline in NRS pain (12 h-recall)
研究概览
简要总结
The primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in patients with peripheral neuropathic pain. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with painful symptoms due to neuropathic pain
- •Provision of signed informed consent
- •Non pregnant females
排除标准
- •Other pain conditions that may confound assessment of neuropathic pain, as judged by the investigator
- •History, and/or presence of somatic disease, which may interfere with the objectives of the study as judged by the investigator
研究组 & 干预措施
1
Experimental
干预措施: AZD1386 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in NRS pain (12 h-recall)
时间窗: Morning and evening 12 hour recall
次要结局
- Response rate, defined as any of the following:NRS (12 h recall) reduced by 30% compared to baseline and NRS (12 h recall) reduced by 50% compared to baseline(Morning and evening 12 hour recall)
- Response rate, defined as any of the following: At least "much improved" on Patient Global Impression of Change global and at least "much improved" on PGIC pain(Day 8, 15 and 22)
- Response rate, defined as any of the following: Change from baseline in Brief Pain Inventory Short Form and Change from baseline in Pain Quality Assessment Scale(Day 1 and 22)
研究者
研究点 (1)
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