Analgecine for the Treatment of Neuropathic Pain

Neuropathic Pain Clinical Trial

Official title:

The Clinical Study of Analgecine for the Treatment of Neuropathic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02633618
• Other study ID #: 2004L04536
• Status: Completed
• Phase: Phase 3
• First received: November 30, 2015
• Last updated: December 14, 2015
• Start date: August 2005
• Est. completion date: December 2005

Study information

• Verified date: December 2015
• Source: VanWorld Pharmaceutical (Rugao) Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Biological:
• Analgecine
Extraction from rabbit skin extract through vaccinia virus inoculation inflammation as an antigen immune reaction.
• Neurotropin
a natural bio-product obtained from rabbit skin extract through vaccinia virus inoculation inflammation as an antigen immune reaction.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
VanWorld Pharmaceutical (Rugao) Company Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes