NCT00085761终止3 期
An International, Multicenter, Randomized, Double-Blind, 12-Week Controlled Study of NGX-4010 for Treatment of Painful HIV-Associated Neuropathy
NeurogesX3 个研究点 分布在 1 个国家开始时间: 2004年6月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 试验地点
- 3
研究概览
简要总结
The purpose of the study is to determine if an investigational drug, NGX-4010 (high-concentration capsaicin patch), is safe, tolerable and effective in treating painful HIV-associated neuropathy.
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 have had HIV-associated neuropathy for at least 2 months, with moderate to severe pain in both feet.
- •Must not have significant pain in feet due to other causes (for example, arthritis).
- •Must have intact 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 (12 weeks).
- •Must not use topical pain medications for HIV-associated neuropathy.
- •Must be able to comply with study requirements such as completing daily pain diary and attending study visits.
- •Must be at least 18 years old, not pregnant, and be able to take care of self independently, with only occasional assistance if needed.
- •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 (3)
Loading locations...
相似试验
已完成
3 期
Study of NGX-4010 for the Treatment of Painful HIV-Associated NeuropathyPeripheral Nervous System DiseasesPainHIV InfectionsNCT00064623NeurogesX300
已完成
2 期
NGX-4010 for the Treatment of Postherpetic NeuralgiaNeuralgiaPainPeripheral Nervous System DiseasesShinglesHerpes ZosterNCT00061776NeurogesX300
已完成
3 期
Controlled Study of NGX-4010 for the Treatment of Postherpetic NeuralgiaNeuralgiaPainPeripheral Nervous System DiseasesHerpes ZosterNCT00068081NeurogesX150
已完成
3 期
Study of NGX-4010 for the Treatment of Postherpetic NeuralgiaPeripheral Nervous System DiseasesPainNeuralgiaShinglesHerpes ZosterNCT00300222NeurogesX400
已完成
3 期
Study of NGX-4010 for the Treatment of Postherpetic NeuralgiaPeripheral Nervous System DiseasesPainNeuralgiaShinglesHerpes ZosterNCT00115310NeurogesX400