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Analgecine for the Treatment of Neuropathic Pain

Primary Purpose

Neuropathic Pain

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Analgecine
Neurotropin
Sponsored by
VanWorld Pharmaceutical (Rugao) Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Analgecine

    Neurotropin

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 30, 2015
    Last Updated
    December 14, 2015
    Sponsor
    VanWorld Pharmaceutical (Rugao) Company Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02633618
    Brief Title
    Analgecine for the Treatment of Neuropathic Pain
    Official Title
    The Clinical Study of Analgecine for the Treatment of Neuropathic Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2005 (undefined)
    Primary Completion Date
    December 2005 (Actual)
    Study Completion Date
    December 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    VanWorld Pharmaceutical (Rugao) Company Limited

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neuropathic Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    135 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Analgecine
    Arm Type
    Experimental
    Arm Description
    3ml, 2 times per day, continuous infusion for two weeks.
    Arm Title
    Neurotropin
    Arm Type
    Active Comparator
    Arm Description
    3ml, 2 times per day, continuous infusion for two weeks.
    Intervention Type
    Biological
    Intervention Name(s)
    Analgecine
    Intervention Description
    Extraction from rabbit skin extract through vaccinia virus inoculation inflammation as an antigen immune reaction.
    Intervention Type
    Biological
    Intervention Name(s)
    Neurotropin
    Intervention Description
    a natural bio-product obtained from rabbit skin extract through vaccinia virus inoculation inflammation as an antigen immune reaction.
    Primary Outcome Measure Information:
    Title
    Change of visual analog scale on pain
    Description
    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.
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lu-Ning Wang
    Organizational Affiliation
    Chinese PLA General Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Analgecine for the Treatment of Neuropathic Pain

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