Analgecine for the Treatment of Neuropathic Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Clinical Study of Analgecine for the Treatment of Neuropathic Pain

Conditions
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Neuropathic Pain

Intervention / Treatment
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* Biological: Analgecine
* Biological: Neurotropin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Analgecine<br>3ml, 2 times per day, continuous infusion for two weeks. | Biological: Analgecine<br>* Extraction from rabbit skin extract through vaccinia virus inoculation inflammation as an antigen immune reaction.<br>|
| Active Comparator: Neurotropin<br>3ml, 2 times per day, continuous infusion for two weeks. | Biological: Neurotropin<br>* a natural bio-product obtained from rabbit skin extract through vaccinia virus inoculation inflammation as an antigen immune reaction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of visual analog scale on pain | 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. | 2 weeks |