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最高研发阶段批准上市 |
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首次获批日期2003-12-09 |
在健康受试者中评价痘苗病毒致炎兔皮提取物注射液多次剂量递增的随机双盲安慰剂对照的安全性和耐受性研究
评价健康受试者多次静脉滴注痘苗病毒致炎兔皮提取物注射液的安全性和耐受性。
在健康受试者中评价痘苗病毒致炎兔皮提取物注射液单次剂量递增的随机双盲安慰剂对照的安全性和耐受性研究
评价健康受试者单次静脉滴注痘苗病毒致炎兔皮提取物注射液的安全性和耐受性。
Efficacy and Safety of Analgecine for Low Back Pain: a Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial
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.
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