临床试验/NCT00354094

NCT00354094终止2 期

A Phase 2B Long-Term, Randomized, Open-Label, Safety And Tolerability Trial Comparing [S,S]-Reboxetine (PNU-165442g) With Routine Care In Patients With Postherpetic Neuralgia (PHN).

Pfizer40 个研究点分布在 12 个国家目标入组 600 人开始时间: 2006年11月最近更新: 2007年11月8日

适应症

试验速览

阶段: 2 期
状态: 终止
发起方: Pfizer
入组人数: 600
试验地点: 40
主要终点: Vital signs

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the long term (up to 2 years) safety and tolerability of [S,S]-Reboxetine in patients with pain after shingles.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
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

•Patients must have pain present for more than 3 months after healing of the shingles skin rash.
•Patients at screening must have a score of >/=40mm on the pain visual analogue scale.

排除标准

•Patients with significant hepatic impairment.
•Patients with other severe pain, that may impair the self-assessment of pain due to postherpetic neuralgia (pain after shingles).

结局指标

主要结局

Vital signs

Physical examination

12-lead ECG

Hematology/Biochemistry

Adverse events

次要结局

Pain Visual Analogue Scale
Patient Global Impression of Change
Neuropathic Pain Symptom Inventory
Modified Brief Pain Inventory - Short Form
SF-12 Health Survey
EQ-5D
Analgesic Treatment Satisfaction Scale
Pain-related Medication Utilization

研究者

发起方

Pfizer

申办方类型

Industry

研究点 (40)

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