Analgecine for Treatment of Low Back Pain

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Analgecine for Low Back Pain: a Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial

Conditions
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Low Back Pain

Intervention / Treatment
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* Drug: Analgecine
* Drug: Neurotropin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experiment<br>Test Drug Group: 2 times a day; 4 tablets per time (2 tablets of Analgecine and 2 tab. of placebo) | Drug: Analgecine<br>* Analgesic drug under test<br>|
| Active Comparator: PosCtrl<br>PosCtrl: Positive Control Group. 2 times a day; 4 tablets / time (2 tab. of Neurotropin and 2 placebo tablets). | Drug: Neurotropin<br>* Analgesic drug as positive control<br>|
| Placebo Comparator: Placebo<br>Placebo Group: 2 times a day; 4 tablets / time (4 placebo tablets). | Drug: Placebo<br>* Blank tablet as placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Visual Analysis Scale on Pain |  | Day 0, 7, 14 and 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |