NCT00614705已完成2 期
A Four Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2A Study Of PH-797804 In The Treatment Of Post-Herpetic Neuralgia
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
- Pfizer
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change from baseline to endpoint in weekly average pain score using the 11-point daily pain rating scale
研究概览
简要总结
This is a proof-of-concept study to determine if PH-797804 reduces neuropathic pain associated with post-herpetic neuralgia. Suitable patients will be randomized to receive either PH-797804 or placebo for 4 weeks, during which time they will also record their pain symptoms using various pain scales.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, at least 18 years of age
- •Patients must have pain present for more than 3 months after healing of the Herpes zoster skin rash. There is no upper limit on the duration of PHN.
- •Patients at screening visit (V1) must have a score ≥40 mm on the Pain Visual Analog Score (VAS).
排除标准
- •Patients having other severe pain, which may impair the self-assessment of the pain due to post-herpetic neuralgia
- •History within the previous year of: myocardial infarction, cardiac arrhythmia (e.g. atrial fibrillation, paroxysmal atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia), left ventricular failure, New York Heart Association (NYHA) Class III-IV congestive heart failure requiring treatment, unstable angina, coronary angioplasty, coronary artery bypass grafting (CABG) or cerebrovascular accident (including transient ischemic attacks).
- •Tuberculosis without treatment and/or positive tuberculin reaction to PPD (Purified Protein Derivative) without known (documented) vaccination with the bacilli Calmette-Guerin vaccine (BCG).
- •A positive approved immunoassay/ELISA blood test for TB (e.g. TB T-SPOT™, QuantiFERON-Gold
- •Any clinically significant skin lesions as described in Common Terminology Criteria for Adverse Events for Dermatology (CTCAE) Version 3.0
- •ECG abnormalities at screening or randomization
- •Evidence of organ dysfunction or hematopoietic disorder
研究组 & 干预措施
1
Experimental
干预措施: PH-797804 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline to endpoint in weekly average pain score using the 11-point daily pain rating scale
时间窗: 4 weeks
次要结局
- PH-797804 pharmacokinetics(Weeks 1, 2, and 4)
- Patient global impression of change(Week 4)
- Neuropathic Pain Symptom Inventory(Baseline and Weeks 1, 2, and 4)
研究者
研究点 (1)
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