NCT01201317已完成2 期
A Study to Investigate the Analgesic Efficacy of AZD2423 Compared 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
- 发起方
- AstraZeneca
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score.
研究概览
简要总结
A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with painful diabetic polyneuropathy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Provision of signed informed consent form
- •Males and female of non-child bearing potential patients aged 18 to 80 years
- •Patients with neuropathic pain due to painful diabetic polyneuropathy.
排除标准
- •Other pain that may confound assessment of neuropathic pain
- •History of treatment failure with more than three adequate trials of medication for neuropathic pain
- •Central neuropathic pain conditions (caused by Central Nervous System injury/disease, eg. Stroke)
研究组 & 干预措施
AZD2423, 150 mg
Experimental
Tablets, 150 mg once daily in the morning.
干预措施: AZD2423 (Drug)
AZD2423, 20 mg
Experimental
Tablets, 20 mg once daily in the morning.
干预措施: AZD2423 (Drug)
Placebo
Placebo Comparator
Tablets, placebo, once daily in the morning.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score.
时间窗: Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28
Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Average Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10; 0=No pain, 10=Worst pain imaginable.
次要结局
- Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score.(Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28)
- Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.(Baseline (mean of Day -5 to Day -1) to Day 28)
- Number of Participants With at Least 50% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.(Baseline (mean of Day -5 to Day -1) to Day 28)
- Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scale (NPSI) Total Score.(Baseline (Day 1) to Day 29 (Visit 7))
研究者
研究点 (1)
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