Trial | NCT02633618  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    135
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.
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.
Study Started
Aug 31
2005
Primary Completion
Dec 31
2005
Study Completion
Dec 31
2005
Last Update
Dec 17
2015
Estimate

Biological Analgecine

Extraction from rabbit skin extract through vaccinia virus inoculation inflammation as an antigen immune reaction.

Biological Neurotropin

a natural bio-product obtained from rabbit skin extract through vaccinia virus inoculation inflammation as an antigen immune reaction.

Neurotropin Active Comparator

3ml, 2 times per day, continuous infusion for two weeks.

Analgecine Experimental

3ml, 2 times per day, continuous infusion for two weeks.

Criteria 

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
No Results Posted