Efficacy and Safety of Analgecine for Low Back Pain: a Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 584
- 试验地点
- 7
- 主要终点
- Change of Visual Analysis Scale on Pain
研究概览
简要总结
The study examines the efficacy and safety of Analgecine in the treatment of chronic pain in patients with low back pain for 3 months after surgical treatment. It is a randomized, placebo-controlled, double blind, multi-center phase III clinical trial. Patients with chronic low back pain for 3 months after surgical treatment is recruited (age between 18 and 70; pain visual analysis scale (VAS) between 3 and 8). After randomization, subjects are divided into 3 groups: 1) Treatment with Analgecine (Experiment group); 2) Treatment with Neurotropin (positive control group); 3) Placebo group. Subjects will be undergone 4 measurement time points on day 0, 7, 14, and 21. In each time points, subjects are required to score their pain with pain VAS and to have regular blood, urine, and renal/liver function tests. The changes of the pain VAS at day 21 are 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic low back pain including patients with spinal degeneration, lumbar herniation, lumbar spinal stenosis, and spondylolisthesis
- •Pain sustained for 3 or more months after surgical treatment.
- •Diagnosis is done by X-ray examination.
- •The Visual analysis Scale for Pain is between 3 and 8.
排除标准
- •Acute low back pain patients.
- •Allergy to the tested drug.
- •Patients with tuberculosis, tumors, Cushing's syndrome, endocrine diseases, neuropathic diseases, psychiatric problems, and serious deficit in heart / liver /renal functions.
- •Patients with pain caused by vascular diseases, stress, or tumors.
- •Patients with pregnancy, lactation, or planning to have pregnancy within 3 months after recruitment.
- •Alcoholic and drug addicted subjects
- •Dementia patients who can cooperate with the study activities.
- •Patients undergone lumber surgery within 3 months at the date of recruitment.
- •Patients who are directly related to the research staff.
- •Patients who have been participated in other drug clinical trial in the past 3 months at the date of the recruitment.
- •Patients who are not fit for the clinical trial based on the research staff observation.
研究组 & 干预措施
Placebo
Placebo Group: 2 times a day; 4 tablets / time (4 placebo tablets).
干预措施: Placebo (Drug)
Experiment
Test Drug Group: 2 times a day; 4 tablets per time (2 tablets of Analgecine and 2 tab. of placebo)
干预措施: Analgecine (Drug)
PosCtrl
PosCtrl: Positive Control Group. 2 times a day; 4 tablets / time (2 tab. of Neurotropin and 2 placebo tablets).
干预措施: Neurotropin (Drug)
结局指标
主要结局
Change of Visual Analysis Scale on Pain
时间窗: Day 0, 7, 14 and 21
次要结局
- ECG(Day 0, 21)
- Routine Hematology Testing(Day 0, 21)
- Routine Urine Testing(Day 0, 21)
- Renal / Liver function tests(Day 0, 21)
- Degree of Improvement of Related Symptoms(Day 0, 7, 14, 21)