跳至主要内容
临床试验/NCT00279032
NCT00279032已完成1 期

A Randomised, Placebo-Controlled, Double-Blind, Parallel Group Study to Investigate the Effects of Chronic Dose Oral GW406381 on Pain and Areas of Hyperalgesia and Allodynia in Patients With Peripheral Nerve Injury as a Result of Trauma or Surgery.

GlaxoSmithKline6 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2003年9月最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
40
试验地点
6
主要终点
To investigate the effect of chronic oral dosing (21 days) of GW406381 compared to placebo, on pain in patients with peripheral nerve injury

研究概览

简要总结

The findings from preclinical animal models confirm the peripheral anti-inflammatory/analgesic activity of GW406381 and also suggest contribution of a central site of action to the anti-hyperalgesic efficacy that may not be shared by other COX-2 inhibitors. A central action is consistent with distribution of GW406381 into the CNS in animals. Furthermore, preliminary data from a positron emission tomography study in which 6 healthy male volunteers received a tracer dose of 11C labelled GW406381 indicate that GW406381 is rapidly absorbed into the central nervous system in man.

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

To investigate the effect of chronic oral dosing (21 days) of GW406381 compared to placebo, on pain in patients with peripheral nerve injury

次要结局

  • To investigate the effect of 21 days oral dosing of GW406381 on thermal hyperalgesia, dynamic allodynia and static mechanical hyperalgesia in patients with peripheral nerve injury.

研究者

申办方类型
Industry

研究点 (6)

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