Analgecine for the Treatment of Neuropathic Pain

NCT02633618 | Completed Phase 3 DMC

• 1 other identifier: 2004L04536
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Analgecine

EXPERIMENTAL

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

Biological: Analgecine

Neurotropin

ACTIVE COMPARATOR

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

Biological: Neurotropin

Interventions

Analgecine BIOLOGICAL

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

Analgecine

Neurotropin BIOLOGICAL

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

Neurotropin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VanWorld Pharmaceutical (Rugao) Company Limited: lead

MeSH Terms

Conditions

Neuralgia

Interventions

neurotropin

Condition Hierarchy (Ancestors)

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

Study Officials

• Lu-Ning Wang

  Chinese PLA General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 17, 2015
• Study Start: August 1, 2005
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: December 17, 2015

Record last verified: 2015-12