NCT00061776已完成2 期
A Randomized, Double-Blind, Controlled Dose Finding Study of NGX-4010 for the Treatment of Postherpetic Neuralgia
NeurogesX29 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2003年6月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 29
研究概览
简要总结
The purpose of the study is determine if an investigational drug, NGX-4010 (high-concentration capsaicin dermal patches) is effective in treating pain associated with post-herpetic neuralgia (PHN).
详细描述
Participants will be randomly assigned to receive initial treatment according to one of three doses (application durations), and will receive either NGX-4010 patch (high-concentration capsaicin) or matching control (low-concentration capsaicin).
Participants who complete the study evaluations for 12 weeks will have the option of receiving up to 3 additional open-label re-treatments over 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
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
- •Key Eligibility Criteria:
- •Must be diagnosed with PHN and be at least 6 months after crusting of the skin vesicles, with moderate to severe pain.
- •Must not have significant pain due to causes other than PHN (for example, arthritis).
- •Painful areas should not be located on the face, above the hairline of the scalp, and/or in proximity to mucous membranes.
- •Must have intact and unbroken skin at the treatment area.
- •Must be prepared to remain on the same pain medications at the same doses as before the study for the entire duration of the study (1-year).
- •Must not have any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of pain.
- •Must not use topical pain medications for PHN.
- •Must be able to comply with study requirements such as completing a daily pain diary, attending study visits and refraining from extensive travel during study participation.
- •No significant medical problems of the heart, kidneys, liver or lungs, or cancer.
- •No history or current problem with substance abuse.
排除标准
- 未提供
研究者
研究点 (29)
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