jRCTs031190113已完成不适用
The Study Regarding Influence on Safety and Efficacy of Switching from Pregabalin to Mirogabalin in Patients with Peripheral Neuropathic Pain
未提供0 个研究点目标入组 150 人开始时间: 2019年10月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Somnolence
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients diagnosed with Peripheral Neuropathic Pain.
- •Patients who is administrated Pregabalin for more than 28 days at enrollment of the study.
- •Patients with more than 40mm of VAS at informed consent and enrollment.
- •Patients with 20 years old or older at enrollment.
- •Patients who give their voluntary Written consent to participate in the study, also patients who are able to understand the procedure of the clinical study and answer a question appropriately.
排除标准
- •Patients who have past history of hypersensitivity to ingredients of Mirogabalin and Pregabalin.
- •Patients who have difficuly participating in the study due to severe complication of Liver Disease, Kidney Disease and Heart Disease.
- •Patients with creatinine clearance less than 30mL/min by Cockroft-Gault Equation at enrollment.
- •Pregnancy patients or patients who have possibility of pregnancy.
- •Nursing mothers.
- •Patients who are inappropriate for participation in the study for other reason in the opinion of the investigator or sub-investigator.
结局指标
主要结局
Somnolence
时间窗: from the enrollment to the end of the study
Rate of occurrence of Somnolence
Dizziness
时间窗: from the enrollment to the end of the study
Rate of occurrence of Dizziness
Peripheral edema
时间窗: from the enrollment to the end of the study
Rate of occurrence of Peripheral edema
次要结局
未报告次要终点