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Analgecine for Treatment of Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Analgecine
Neurotropin
Placebo
Sponsored by
VanWorld Pharmaceutical (Rugao) Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Second Hospital of Sun Yat-sen University
  • No.3 Hospital of Hebei Medical University
  • Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Shanghai Sixth People's Hosptial
  • Zhong Shan Hospital, Fudan University
  • Xijing Hospital
  • Tiangjin People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Experiment

PosCtrl

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change of Visual Analysis Scale on Pain

Secondary Outcome Measures

ECG
Routine Hematology Testing
Routine Urine Testing
Renal / Liver function tests
Degree of Improvement of Related Symptoms

Full Information

First Posted
June 17, 2014
Last Updated
December 8, 2015
Sponsor
VanWorld Pharmaceutical (Rugao) Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02168010
Brief Title
Analgecine for Treatment of Low Back Pain
Official Title
Efficacy and Safety of Analgecine for Low Back Pain: a Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VanWorld Pharmaceutical (Rugao) Company Limited

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
584 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experiment
Arm Type
Experimental
Arm Description
Test Drug Group: 2 times a day; 4 tablets per time (2 tablets of Analgecine and 2 tab. of placebo)
Arm Title
PosCtrl
Arm Type
Active Comparator
Arm Description
PosCtrl: Positive Control Group. 2 times a day; 4 tablets / time (2 tab. of Neurotropin and 2 placebo tablets).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Group: 2 times a day; 4 tablets / time (4 placebo tablets).
Intervention Type
Drug
Intervention Name(s)
Analgecine
Intervention Description
Analgesic drug under test
Intervention Type
Drug
Intervention Name(s)
Neurotropin
Intervention Description
Analgesic drug as positive control
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Blank tablet as placebo.
Primary Outcome Measure Information:
Title
Change of Visual Analysis Scale on Pain
Time Frame
Day 0, 7, 14 and 21
Secondary Outcome Measure Information:
Title
ECG
Time Frame
Day 0, 21
Title
Routine Hematology Testing
Time Frame
Day 0, 21
Title
Routine Urine Testing
Time Frame
Day 0, 21
Title
Renal / Liver function tests
Time Frame
Day 0, 21
Title
Degree of Improvement of Related Symptoms
Time Frame
Day 0, 7, 14, 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Chen-Lung Lin, MD, PhD
Organizational Affiliation
Graduate School of Medicine, Kaohsiung Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jian Dong, MD, PhD
Organizational Affiliation
Zhong Shan Hospital, Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
No.3 Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Shanghai Sixth People's Hosptial
City
Shanghai
State/Province
Jiangsu
Country
China
Facility Name
Zhong Shan Hospital, Fudan University
City
Shanghai
State/Province
Jiangsu
Country
China
Facility Name
Xijing Hospital
City
Xian
State/Province
Shaanxi
Country
China
Facility Name
Tiangjin People's Hospital
City
Tianjin
Country
China

12. IPD Sharing Statement

Learn more about this trial

Analgecine for Treatment of Low Back Pain

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