Analgecine for Treatment of Low Back Pain

Efficacy and Safety of Analgecine for Low Back Pain: a Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Drug: Analgecine; Drug: Neurotropin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 584
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Tianjin, China
    • Tiangjin People's Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • Second Hospital of Sun Yat-sen University
  • Hebei
    • Shijiazhuang, Hebei, China
      • No.3 Hospital of Hebei Medical University
  • Hubei
    • Wuhan, Hubei, China
      • Wuhan Union Hospital, Tongji Medical college, Huazhong University of Science and Technology
  • Jiangsu
    • Shanghai, Jiangsu, China
      • Shanghai Sixth People's Hosptial
    • Shanghai, Jiangsu, China
      • Zhong Shan Hospital, Fudan University
  • Shaanxi
    • Xian, Shaanxi, China
      • Xijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with chronic low back pain including patients with spinal degeneration, lumbar herniation, lumbar spinal stenosis, and spondylolisthesis
• Pain sustained for 3 or more months after surgical treatment.
• Diagnosis is done by X-ray examination.
• The Visual analysis Scale for Pain is between 3 and 8.

Exclusion Criteria:

• Acute low back pain patients.
• Allergy to the tested drug.
• Patients with tuberculosis, tumors, Cushing's syndrome, endocrine diseases, neuropathic diseases, psychiatric problems, and serious deficit in heart / liver /renal functions.
• Patients with pain caused by vascular diseases, stress, or tumors.
• Patients with pregnancy, lactation, or planning to have pregnancy within 3 months after recruitment.
• Alcoholic and drug addicted subjects
• Dementia patients who can cooperate with the study activities.
• Patients undergone lumber surgery within 3 months at the date of recruitment.
• Patients who are directly related to the research staff.
• Patients who have been participated in other drug clinical trial in the past 3 months at the date of the recruitment.
• Patients who are not fit for the clinical trial based on the research staff observation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experiment; Test Drug Group: 2 times a day; 4 tablets per time (2 tablets of Analgecine and 2 tab. of placebo)	Drug: Analgecine; Analgesic drug under test
Active Comparator: PosCtrl; PosCtrl: Positive Control Group. 2 times a day; 4 tablets / time (2 tab. of Neurotropin and 2 placebo tablets).	Drug: Neurotropin; Analgesic drug as positive control
Placebo Comparator: Placebo; Placebo Group: 2 times a day; 4 tablets / time (4 placebo tablets).	Drug: Placebo; Blank tablet as placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change of Visual Analysis Scale on Pain	Day 0, 7, 14 and 21

Secondary Outcome Measures

Outcome Measure	Time Frame
ECG	Day 0, 21
Routine Hematology Testing	Day 0, 21
Routine Urine Testing	Day 0, 21
Renal / Liver function tests	Day 0, 21
Degree of Improvement of Related Symptoms	Day 0, 7, 14, 21

Collaborators and Investigators

• Sponsor: VanWorld Pharmaceutical (Rugao) Company Limited
• Investigators: Study Director: Steve Chen-Lung Lin, MD, PhD, Graduate School of Medicine, Kaohsiung Medical University; Principal Investigator: Jian Dong, MD, PhD, Zhong Shan Hospital, Fudan University

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: June 17, 2014
• First Submitted That Met QC Criteria: June 17, 2014
• First Posted (Estimate): June 19, 2014

Study Record Updates

• Last Update Posted (Estimate): December 9, 2015
• Last Update Submitted That Met QC Criteria: December 8, 2015
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Immunologic Factors; Adjuvants, Immunologic; Anticonvulsants; Neurotropin
• Other Study ID Numbers: vw1401