Analgecine for Treatment of Low Back Pain

NCT02168010 | Completed Phase 3 DMC

• 1 other identifier: vw1401
• Study Type: interventional
• Target: 584
• Locations: 1 country
• Sites: 7

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change of Visual Analysis Scale on Pain

  Day 0, 7, 14 and 21

Secondary Outcomes (5)

• 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

Study Arms (3)

Experiment

EXPERIMENTAL

Test Drug Group: 2 times a day; 4 tablets per time (2 tablets of Analgecine and 2 tab. of placebo)

Drug: Analgecine

PosCtrl

ACTIVE COMPARATOR

PosCtrl: Positive Control Group. 2 times a day; 4 tablets / time (2 tab. of Neurotropin and 2 placebo tablets).

Drug: Neurotropin

Placebo

PLACEBO COMPARATOR

Placebo Group: 2 times a day; 4 tablets / time (4 placebo tablets).

Drug: Placebo

Interventions

Analgecine DRUG

Analgesic drug under test

Experiment

Neurotropin DRUG

Analgesic drug as positive control

PosCtrl

Placebo DRUG

Blank tablet as placebo.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VanWorld Pharmaceutical (Rugao) Company Limited: lead

Study Sites (7)

Second Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

No.3 Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Shanghai Sixth People's Hosptial

Shanghai, Jiangsu, China

Location

Zhong Shan Hospital, Fudan University

Shanghai, Jiangsu, China

Location

Xijing Hospital

Xi'an, Shaanxi, China

Location

Tiangjin People's Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

neurotropin

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Steve Chen-Lung Lin, MD, PhD

  Graduate School of Medicine, Kaohsiung Medical University

  STUDY DIRECTOR

• Jian Dong, MD, PhD

  Zhong Shan Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: June 19, 2014
• Study Start: October 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 9, 2015

Record last verified: 2014-08

Locations

CN (7)