Analgecine for the Treatment of Neuropathic Pain

VanWorld Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Neuropathic Pain

Treatments: Biological: Neurotropin; Biological: Analgecine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02633618

2004L04536

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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135 participants in 2 patient groups

Analgecine

Experimental group

Description:

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

Treatment:

Biological: Analgecine

Neurotropin

Active Comparator group

Description:

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

Treatment:

Biological: Neurotropin