Analgecine for the Treatment of Neuropathic Pain

The Clinical Study of 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.

Study Overview

• Status: Completed
• Conditions: Neuropathic Pain
• Intervention / Treatment: Biological: Analgecine; Biological: Neurotropin

Detailed Description

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 Type: Interventional
• Enrollment (Actual): 135
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with the established medical records;
2. Patients with age of 18 years to 80 years old.
3. Patients with neuropathic pain
4. Patients at child-bearing age with negative pregnancy tests and contraceptive measures ( oral or injectable contraceptives) taken throughout the course of the experiment
5. Patients with signed informed consent.

Exclusion Criteria:

1. Patients younger than 18 years old or older 80 years old
2. Patients of dementia who can not determine efficacy
3. Patients who was pregnant, nursing or who may become pregnant in the study course and did not take effective contraceptive measures.
4. Patients with the history of allergic reactions
5. Patients suffering from tuberculosis, cancer and other organic disease
6. Patients who are alcoholics and drug addicts
7. Others who were determined by physician not to be a candidate for this clinical observation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: VanWorld Pharmaceutical (Rugao) Company Limited
• Investigators: Study Director: Lu-Ning Wang, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion (Actual): December 1, 2005
• Study Completion (Actual): December 1, 2005

Study Registration Dates

• First Submitted: November 30, 2015
• First Submitted That Met QC Criteria: December 14, 2015
• First Posted (Estimate): December 17, 2015

Study Record Updates

• Last Update Posted (Estimate): December 17, 2015
• Last Update Submitted That Met QC Criteria: December 14, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Immunologic Factors; Adjuvants, Immunologic; Anticonvulsants; Neurotropin
• Other Study ID Numbers: 2004L04536