NCT01426230已完成不适用
A Phase 4, Open Label, Study of Safety and Effectiveness of GRALISE™(Gabapentin) Tablets in the Treatment of Patients With Postherpetic Neuralgia in Clinical Practice
Depomed0 个研究点目标入组 201 人开始时间: 2011年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 主要终点
- Change From Baseline to End of Study in LOCF VAS
研究概览
简要总结
Study objective is to assess the safety and effectiveness of once- daily GRALISE in clinical practice
详细描述
Open Label, single arm, 2wk titration, 6 wk stable dosing, 8 wk of total treatment, 1wk dose tapering
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •Men or Women 18 years or older who are suffering from PHN
排除标准
- •Patient is Pregnant or a nursing mother
- •Patient has hypersensitivity to gabapentin
- •Patient has an estimated creatinine clearance of <30 mL/min or is in hemodialysis
结局指标
主要结局
Change From Baseline to End of Study in LOCF VAS
时间窗: 8 weeks (Baseline and Week 8)
Change from baseline in pain score on visual analog scale (VAS) (intensity scored from "No Pain" (0mm) to "Worst Possible Pain" (100mm)) at Week 8 of treatment; last observation carried forward (LOCF) analysis
次要结局
未报告次要终点
研究者
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