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Analgecine for the Treatment of Neuropathic Pain

NCT ID: NCT02633618

Last Updated: 2015-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2005-12-31

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.

Conditions

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Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Analgecine

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

Group Type EXPERIMENTAL

Analgecine

Intervention Type BIOLOGICAL

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

Neurotropin

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

Group Type ACTIVE_COMPARATOR

Neurotropin

Intervention Type BIOLOGICAL

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

Interventions

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Analgecine

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

Intervention Type BIOLOGICAL

Neurotropin

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VanWorld Pharmaceutical (Rugao) Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lu-Ning Wang

Role: STUDY_DIRECTOR

Chinese PLA General Hospital

Other Identifiers

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2004L04536

Identifier Type: -

Identifier Source: org_study_id