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.
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
- 5
- 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
- 否
入选标准
- •Baseline average daily Pain Score of greater than or equal to 4 (averaged over the 7 days prior to Treatment Visit 1), as reported on the 11 point pain intensity numerical rating scale.
- •Subjects on medications for neuropathic pain or received nerve blocks for neuropathic pain.
排除标准
- •Known history of hypersensitivity or intolerance to acetaminophen, paracetamol, aspirin, COX-2 inhibitors or NSAIDs.
- •Subject is unable to discontinue NSAIDs or COX-2 inhibitors (except aspirin as a cardioprotective; certain doses apply), topical lidocaine and topical capsaicin for the treatment of pain for the period prior to randomization and for the duration of the study.
- •Subject is unable to refrain from sedative use during the study (benzodiazepines prescribed as hypnotic sleep agents allowed).
- •Subject is unable to refrain from nerve blocks for 4 weeks prior to randomisation and during the study.
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
研究点 (5)
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