A Multi-center, Randomized, Double-blind, Parallel, Active-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of 'GLA5PR GLARS-NF1 Tab.' and 'Pregabalin' in Peripheral Neuropathic Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Daily Pain Rating Scale
研究概览
简要总结
A multi-center, randomized, double-blind, parallel, active-controlled phase III clinical trial to evaluate the efficacy and safety of 'GLA5PR GLARS-NF1 Tab.' and 'Pregabalin' in peripheral 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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •both male and female who are over 19-year-old
- •patient whose pain scale is 4~9
- •patient who has pain of mononeuropathy
排除标准
- •patient whose CCr is <60ml/min
- •patient who has other pain which is not from mononeuropathy
- •patient who is going to have an operation during this study
- •patient who has abnormal ECG
研究组 & 干预措施
GLA5PR GLARS-NF1 & Pregabalin placebo
GLA5PR GLARS-NF1 150mg, 300mg tablet by mouth, every after dinner for about 3 months Pregabalin placebo 75mg, 150mg, 300mg capsules by mouth, every after breakfast and dinner for about 3 months
干预措施: GLA5PR GLARS-NF1 (Drug)
GLA5PR GLARS-NF1 & Pregabalin placebo
GLA5PR GLARS-NF1 150mg, 300mg tablet by mouth, every after dinner for about 3 months Pregabalin placebo 75mg, 150mg, 300mg capsules by mouth, every after breakfast and dinner for about 3 months
干预措施: Pregabalin placebo (Drug)
GLA5PR GLARS-NF1 placebo & Pregabalin
GLA5PR GLARS-NF1 placebo 150mg, 300mg tablet by mouth, every after dinner for about 3 months Pregabalin 75mg, 150mg, 300mg capsules by mouth, every after breakfast and dinner for about 3 months
干预措施: GLA5PR GLARS-NF1 placebo (Drug)
GLA5PR GLARS-NF1 placebo & Pregabalin
GLA5PR GLARS-NF1 placebo 150mg, 300mg tablet by mouth, every after dinner for about 3 months Pregabalin 75mg, 150mg, 300mg capsules by mouth, every after breakfast and dinner for about 3 months
干预措施: Pregabalin (Drug)
结局指标
主要结局
Daily Pain Rating Scale
时间窗: 12-week
次要结局
未报告次要终点