Analgecine for the Treatment of Neuropathic Pain

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.

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Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Analgecine

Biological

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

Neurotropin

Biological

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

Primary outcomes

Change of visual analog scale on pain

Time frame: 2 weeks

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.

Sponsors and collaborators

Lead sponsor

VanWorld Pharmaceutical (Rugao) Company Limited

Industry

Registry information

Official study title

The Clinical Study of Analgecine for the Treatment of Neuropathic Pain

Important dates

Study start: 2005
Primary completion: 2005
Study completion: 2005
First posted: Dec 17, 2015
Registry last updated: Dec 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed