A Phase IIa, Double-Blind, Randomised, Parallel-Group, Multi-Centre Study to Evaluate the Analgesic Efficacy of 28 Days Oral Administration of AZD2066 Compared to Placebo in Peripheral Neuropathic Pain Patients With Mechanical Hypersensitivity
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Change in Mean Numerical Rating Scale (NRS) Pain Score From Baseline to Last 5 Days on Treatment
研究概览
简要总结
The purpose of this study is to investigate if 28 days of treatment with AZD2066 compared to placebo can relieve the pain arising from the nervous system when the patients are touched by something that should not cause pain or have severe pain when they are touched by something that should only cause a little 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
- 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.
- •Male or non-fertile females
- •Painful symptoms due to neuropathic pain for a period of 3 months to 5 years, associated with mechanical allodynia and/or punctate hyperalgesia.
排除标准
- •Other pain that may confound assessment of neuropathic pain.
- •Diagnosis of any severe neurological disease.
- •History of significant psychiatric disease/condition and/or history of psychotic disorders among first degree relatives.
研究组 & 干预措施
A
干预措施: AZD2066 (Drug)
B
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Mean Numerical Rating Scale (NRS) Pain Score From Baseline to Last 5 Days on Treatment
时间窗: Change in mean pain intensity from 5-day baseline to the last 5 days on treatment, measure twice daily with NRS (12-hour recall)
Mean pain intensity for 5-day baseline period (morning Day -5 to evening 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 NRS scale (0-10). 0=No pain, 10=Worst pain imaginable.
次要结局
- Patients With ≥30% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28(28 days)
- Patients With ≥50% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28(28 days)
- Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" (Responder Rate) at Day 28(28 days)
- Change in Short Form McGill Pain Questionnaire (SF-MPQ) Sensory Index From Baseline to Day 28(28 days)
- Change in SF-MPQ Affective Index From Baseline to Day 28(28 days)
- Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28(28 days)
- Change in BPI-SF Pain Interference From Baseline to Day 28(28 days)