Efficacy of Transdermal Fentanyl for Chronic Neuropathic Pain

Johns Hopkins University0 个研究点目标入组 53 人开始时间: 2003年10月最近更新: 2017年8月24日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Johns Hopkins University
入组人数: 53
主要终点: Change in pain intensity (0-10) and daily activity

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The efficacy of fentanyl TTS for the treatment of neuropathic pain remains to be established, although opioids in general are clearly effective for neuropathic pain and fentanyl TTS has been shown to be effective for treating other types of pain. We propose to measure functional outcomes, pain relief and side effects of fentanyl TTS for the treatment of neuropathic pain. Measures will be made at baseline and after titrating the drug to an effective level.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age >18 years
•Neuropathic pain persisting for > 3 months
•Pain over the immediate previous three months
•The average of the least and usual pain intensity rating of 3 or greater (0-10 numerical rating scale) during the last week prior to enrollment

排除标准

•A history of substance abuse
•Allergic reaction to an opioid
•Significant pain of alternate etiology other than the neuropathic pain state
•Severe pulmonary disease
•Recent myocardial infarction (within the preceding three months)
•Pregnancy
•Encephalopathy
•Those with life expectancy of less than six months and HIV seropositivity.

结局指标

主要结局

Change in pain intensity (0-10) and daily activity

次要结局

Cognition (digital symbol and grooved peg-board)
Impairment of function (MPI) and affect (BDI)
Pain relief (0-100%)

研究者

发起方

Johns Hopkins University

申办方类型

Other

责任方

Sponsor

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