NCT00264875已完成3 期
An Open-Label, Extension Safety And Efficacy Trial Of Pregabalin In Subjects With Neuropathic Pain Associated With Human Immunodeficiency Virus (HIV) Neuropathy
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2006年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Mean Visual Analogue Scale (VAS) Pain Scores
研究概览
简要总结
To evaluate the safety and efficacy of pregabalin in reducing neuropathic pain associated with HIV neuropathy
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in the preceding A0081066 double-blind trial met the entry criteria for that trial and completed A0081066 study through visit 7
排除标准
- •Experienced serious adverse event during the A0081066 trial that was considered related or possibly related to study medication by the investigator or sponsor
- •non-compliant during A0081066 trial
- •clinically significant or unstable medical condition both HIV-related and non-HIV related including but not limited to, cardiac, pulmonary or hepatorenal disease that, in the opinion of the investigator, would compromise participation in the study
研究组 & 干预措施
1
Experimental
干预措施: pregabalin (Drug)
结局指标
主要结局
Mean Visual Analogue Scale (VAS) Pain Scores
时间窗: Baseline, Week 4, Week 8, Week 12, and Endpoint
Pain scores were assessed on a 100 mm Visual Analogue Scale (VAS); scores range from 0= no pain to 100= worse pain. Subjects assessed their pain during the last week. Endpoint = last non-missing observation carried forward after Baseline visit.
次要结局
未报告次要终点
研究者
研究点 (1)
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