Analgecine for the Treatment of Neuropathic Pain

Last updated: December 14, 2015
Sponsor: VanWorld Pharmaceutical (Rugao) Company Limited
Overall Status: Completed

Phase

3

Condition

Chronic Pain

Pain (Pediatric)

Neuropathy

Treatment

N/A

Clinical Study ID

NCT02633618
2004L04536
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 anddid 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 clinicalobservation

Study Design

Total Participants: 135
Study Start date:
August 01, 2005
Estimated Completion Date:
December 31, 2005

Study 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.