NCT00301223已完成3 期
An 8-Week Multi-Center, Randomized, Double Blind, Placebo-Controlled Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin (150mg-600mg/Day) Using A Flexible Dosing Schedule In The Treatment Of Subjects With Symptoms Of Neuropathic Pain
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.8 个研究点 分布在 1 个国家目标入组 309 人开始时间: 2006年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 309
- 试验地点
- 8
- 主要终点
- The primary efficacy parameter is the endpoint mean pain score based on the pain scores from the subject's daily pain diaries.
研究概览
简要总结
The objective of this study is to evaluate the efficacy, safety and tolerability for pregabalin using a flexible, optimized dose schedule compared to placebo in relieving the symptoms of neuropathic pain.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese outpatient of age 18 to 75
- •At screening and baseline, a score of greater than 40 mm on the visual log scale of SF-MPQ
排除标准
- •Neurologic disorders unrelated to neuropathic pain, which in the opinion of the investigator, might impair the assessment of pain
- •Serum creatinine clearance greater than 60 ml/min
结局指标
主要结局
The primary efficacy parameter is the endpoint mean pain score based on the pain scores from the subject's daily pain diaries.
次要结局
- The secondary efficacy parameters include the weekly mean pain scores from the subject's daily pain diaries
- The Short Form McGill Pain Questionnaire
- The responder rate defined as the proportion of subjects reporting a decrease of at least 30% in the weekly mean pain scores in each treatment group.
- The Sleep interference score (from subject pain diary)
- The Clinician and Patient Global Impression of Change (CGIC and PGIC)
- Addtionally, the safety and tolerability of Pregabalin will also be evaluated.
研究者
研究点 (8)
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