The Clinical Study of Analgecine for the Treatment of Neuropathic Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 主要终点
- Change of visual analog scale on pain
研究概览
简要总结
A randomized, open-label , positive drug controlled (Neurotropin,Japan organs Pharmaceutical Co., Ltd. ), multi-center study to evaluate Analgecine's efficacy and safety for the treatment of neuropathic pain.
详细描述
The study was designed to evaluate the efficacy and safety of Analgecine for the treatment of neuropathic pain for 2 weeks. It was a randomized, open-label , positive drug controlled, multi-center study phase III clinical trial. Patients were recruited with age between 18 and 80 and visual analysis scale (VAS) between 3 and 8. After randomization, subjects were divided into 2 groups: 1) Treatment with Analgecine as experiment group; 2) Treatment with Neurotropin as positive control group. There are 3 measurement time points on day 0, 7, 14 after treatment to score patients pain with VAS. The changes of the VAS score at day 14 were compared between groups.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with the established medical records;
- •Patients with age of 18 years to 80 years old.
- •Patients with neuropathic pain
- •Patients at child-bearing age with negative pregnancy tests and contraceptive measures ( oral or injectable contraceptives) taken throughout the course of the experiment
- •Patients with signed informed consent.
排除标准
- •Patients younger than 18 years old or older 80 years old
- •Patients of dementia who can not determine efficacy
- •Patients who was pregnant, nursing or who may become pregnant in the study course and did not take effective contraceptive measures.
- •Patients with the history of allergic reactions
- •Patients suffering from tuberculosis, cancer and other organic disease
- •Patients who are alcoholics and drug addicts
- •Others who were determined by physician not to be a candidate for this clinical observation
结局指标
主要结局
Change of visual analog scale on pain
时间窗: 2 weeks
Pain was scored by VAS 10 points (visual analog scale). The degree of pain gradually increases from 0 to 10. The subtraction mark rate of VAS value before and after treatment and the grade decrease of associated symptoms will be regarded as the main curative effects indexes.
次要结局
未报告次要终点