NCT00857623已完成2 期
A Phase IIa, Double-Blind, Randomised, Parallel-Group, Multi-Centre Study to Evaluate the Analgesic Efficacy of 28 Days' Oral Administration of AZD2066 Compared With Placebo in Patients With Painful Diabetic Neuropathy
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
- 127
- 试验地点
- 3
- 主要终点
- Change in Mean Numerical Rating Scale (NRS) Score From Baseline to Last 5 Days of Treatment
研究概览
简要总结
The purpose of this study is to investigate if AZD2066 can relieve the pain arising from painful diabetic neuropathy compared to placebo.
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 informed consent prior to any study specific procedures.
- •Clinical diagnosis of painful diabetic neuropathy.
- •non-fertile females
排除标准
- •Other pain that may confound assessment of neuropathic pain.
- •Ongoing significant peripheral arterial diseases, skin ulcers, or amputation in the lower extremities.
- •History of psychotic disorders among first degree relatives.
研究组 & 干预措施
1
Experimental
干预措施: AZD2066 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Mean Numerical Rating Scale (NRS) Score From Baseline to Last 5 Days of Treatment
时间窗: From baseline to day 28
Change of mean pain intensity from 5-day baseline to the last 5 days of treatment, measured twice daily with NRS (12 hours recall). Mean pain intensity for 5-day baseline period (evening Day -6 to moning Day-1) and mean pain intensity for last 5 days on treatment (ie, last dose day and the 4 preceding calendar days) was calculated based on the numerical rating scale (NRS)(0-10). 0=No pain, 10=Worst pain imaginable.
次要结局
- Daily Numerical Rating Scale (NRS) Pain Scores and Change From Baseline Over Time to Day 28.(From baseline to 28 days)
- Number of Patients With >=30% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28(28 days)
- Number of Patients With >=50% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28(28 days)
- Number of Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" at Day 28.(28 days)
- Change in McGill Pain Questionnaire Short Form (MPQ-SF) Sensory Index From Baseline to Day 28.(From baseline to day 28.)
- Change in McGill Pain Questionnaire Short Form (MPQ-SF) Affective Index From Baseline to Day 28.(From baseline to day 28.)
- Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28.(From baseline to day 28..)
- Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Interference From Baseline to Day 28.(From baseline to 28 days)
研究者
研究点 (3)
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