NCT00424372已完成3 期
A LONG-TERM STUDY TO EVALUATE SAFETY AND EFFICACY STUDY OF PREGABALIN IN THE TREATMENT OF POSTHERPETIC NEURALGIA.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.33 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2007年1月12日最近更新:
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
- 126
- 试验地点
- 33
- 主要终点
- Summary of Adverse Events
研究概览
简要总结
To evaluate the safety of the long-term use of pregabalin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 who completed the 13-week treatment of postherpetic neuralgia in Study A
- •Patients must be able to understand and cooperate with study procedures and have signed a written informed consent prior to entering the study.
排除标准
- •Patients who experienced serious adverse events in the preceding study (A0081120) that were determined by the investigator or the study sponsor to be causally related to the study medication.
- •Patients exhibiting treatment non-compliance in the preceding study (A0081120)
研究组 & 干预措施
pregabalin
Experimental
干预措施: pregabalin (Drug)
结局指标
主要结局
Summary of Adverse Events
时间窗: 52 weeks
Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects are counted only once per treatment in each row.
次要结局
- Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score(52 weeks)
- Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale(52 weeks)
- Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score(52 weeks)
- Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score(52 weeks)
- Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity(52 weeks)
研究者
研究点 (33)
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