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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
584
Analgesic drug under test
Analgesic drug as positive control
Blank tablet as placebo.
Second Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
No.3 Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Shanghai Sixth People's Hosptial
Shanghai, Jiangsu, China
Zhong Shan Hospital, Fudan University
Shanghai, Jiangsu, China
Xijing Hospital
Xi'an, Shaanxi, China
Tiangjin People's Hospital
Tianjin, China
Change of Visual Analysis Scale on Pain
Time frame: Day 0, 7, 14 and 21
ECG
Time frame: Day 0, 21
Routine Hematology Testing
Time frame: Day 0, 21
Routine Urine Testing
Time frame: Day 0, 21
Renal / Liver function tests
Time frame: Day 0, 21
Degree of Improvement of Related Symptoms
Time frame: Day 0, 7, 14, 21
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