NCT00506610撤回2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Flexible Escalating -Dose, Pilot Analgesic Efficacy Study of T-62 in Subjects With Postherpetic Neuralgia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Pfizer
- 试验地点
- 16
- 主要终点
- Pain Intensity Difference (PID) scores (derived from data obtained using the 11 point Likert pain rating scale)
研究概览
简要总结
The purpose of this study is to determine whether T-62 is effective in providing relief of pain that can occur after an individual experiences a shingles outbreak, which is an infection in adults caused by the same virus that causes chicken pox.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a clinical diagnosis of Postherpetic Neuralgia (PHN)
- •Experiencing pain for at least 3 months after the healing of shingles rash
- •Has at least a weekly average pain intensity of equal to or greater than 4 out of 10
- •Females must not be pregnant or breastfeeding and practicing an acceptable method of birth control, or be surgically sterile or post-menopausal
- •Will not consume grapefruit or grapefruit juice during the study
排除标准
- •Has a current acute or unstable chronic disease other than Postherpetic Neuralgia (PHN)
- •Has clinically important medical disorder
- •Uses certain types of medications for heart conditions
- •Unwilling/unable to discontinue use of medications for treatment of neuropathic pain
- •Has a history of hypersensitivity to any medication or soy product
- •Has liver or kidney disease
- •Has asthma that required treatment within the last year
- •Has HIV or hepatitis (other than hepatitis A)
- •Has a history of alcohol abuse within the past 2 years
- •Has a history of (within last 2 years) or currently abuses prescription or illegal drugs
结局指标
主要结局
Pain Intensity Difference (PID) scores (derived from data obtained using the 11 point Likert pain rating scale)
时间窗: During each Treatment Phase Visit
Various pain related assessment
时间窗: During each Treatment Phase Visit
Clinical Global Impression of Change (CGIC) and Subject Global Impression of Change (SGIC ) scores
时间窗: At each Treatment Phase Visit
次要结局
- Incidence, intensity, relationship, and seriousness of treatment-emergent AEs by dose and by treatment group.
- Treatment-emergent changes in safety assessments
- Evaluation of T-62 plasma concentrations(At various timepoints during the study)
研究者
研究点 (16)
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