NCT00376454已完成2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Tolerability of a 14 Day Treatment Course of GW493838 50mg Compared to Placebo in Subjects With Peripheral Neuropathic Pain
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 33
- 主要终点
- Pain intensity
研究概览
简要总结
The purpose of this study was to determine the analgesic effect of GW493838 in patients with post-herpetic neuralgia or peripheral nerve injury caused by trauma or surgery.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(subjects must meet all of the following criteria in order to be eligible for this study):
- •Females of non-child-bearing potential
- •diagnosis of peripheral neuropathic pain as a result of: postherpetic neuralgia (PHN) from shingles for at least 3 months duration OR focal neuropathic pain related to nerve injury caused by trauma or surgery
- •defined area of pain
排除标准
- •discontinue agents for the treatment of neuropathic pain
- •unable to refrain from alcohol and sedative use during the study
- •confounding chronic pain which could not be differentiated from the peripheral neuropathic pain under study
- •intractable pain of unknown origin or active infection in the area of nerve injury.
- •clinically significant medical history or abnormality found on physical examination, laboratory assessment or ECG at Screening or Baseline
- •severe asthma that has required oral corticosteroid use in the last 12 months or the subject had severe asthma that required, at anytime, hospitalization or mechanical ventilation support.
- •clinical evidence of major depression (by medical history) except those subjects controlled by SSRIs.
- •a known allergy or hypersensitivity to any of the investigational products (including rescue analgesia- acetaminophen), or pharmacological class of the investigational product (i.e. adenosine) and/or investigational product excipients.
- •a clinically significant abuse of substances, defined as: Patterns of substance intake consistent with disruption of normal function in society; Past or current impairment of organ function reasonably related to substance intake; Any indication of difficulty in abstaining from substances for the duration of the study.
- •had previously participated in a clinical study during the past 30 days in which the subject was exposed to an investigational or non-investigational drug or device
- •currently participating in another clinical study in which the subject was exposed to an investigational or non-investigational drug or device
- •prior blood reduction (450 mL or more) during the previous 30 days
- •at risk of non-compliance
- •a woman of childbearing potential or a woman who was lactating.
结局指标
主要结局
Pain intensity
次要结局
- Safety Pain relief Global Impression of Change Pain quality Evoked pain intensity Area of allodynia Onset of effect Responder rate Rescue medication pharmacokinetics
研究者
研究点 (33)
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