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Analgecine for Treatment of Low Back Pain

NCT02168010 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 584

Last updated 2015-12-09

No results posted yet for this study

Summary

The study examines the efficacy and safety of Analgecine in the treatment of chronic pain in patients with low back pain for 3 months after surgical treatment. It is a randomized, placebo-controlled, double blind, multi-center phase III clinical trial. Patients with chronic low back pain for 3 months after surgical treatment is recruited (age between 18 and 70; pain visual analysis scale (VAS) between 3 and 8). After randomization, subjects are divided into 3 groups: 1) Treatment with Analgecine (Experiment group); 2) Treatment with Neurotropin (positive control group); 3) Placebo group. Subjects will be undergone 4 measurement time points on day 0, 7, 14, and 21. In each time points, subjects are required to score their pain with pain VAS and to have regular blood, urine, and renal/liver function tests. The changes of the pain VAS at day 21 are compared between groups.

Conditions

  • Low Back Pain

Interventions

DRUG

Analgecine

Analgesic drug under test

DRUG

Neurotropin

Analgesic drug as positive control

DRUG

Placebo

Blank tablet as placebo.

Sponsors & Collaborators

  • VanWorld Pharmaceutical (Rugao) Company Limited

    lead INDUSTRY

Principal Investigators

  • Steve Chen-Lung Lin, MD, PhD · Graduate School of Medicine, Kaohsiung Medical University

  • Jian Dong, MD, PhD · Zhong Shan Hospital, Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02168010 on ClinicalTrials.gov