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Analgecine for Treatment of Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168010
Recruitment Status : Completed
First Posted : June 19, 2014
Last Update Posted : December 9, 2015
Sponsor:
Information provided by (Responsible Party):
VanWorld Pharmaceutical (Rugao) Company Limited

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Drug: Analgecine Drug: Neurotropin Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 584 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Analgecine for Low Back Pain: a Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial
Study Start Date : October 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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.




Primary Outcome Measures :
  1. Change of Visual Analysis Scale on Pain [ Time Frame: Day 0, 7, 14 and 21 ]

Secondary Outcome Measures :
  1. ECG [ Time Frame: Day 0, 21 ]
  2. Routine Hematology Testing [ Time Frame: Day 0, 21 ]
  3. Routine Urine Testing [ Time Frame: Day 0, 21 ]
  4. Renal / Liver function tests [ Time Frame: Day 0, 21 ]
  5. Degree of Improvement of Related Symptoms [ Time Frame: Day 0, 7, 14, 21 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168010


Locations
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China, Guangdong
Second Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
China, Hebei
No.3 Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
China, Hubei
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
China, Jiangsu
Shanghai Sixth People's Hosptial
Shanghai, Jiangsu, China
Zhong Shan Hospital, Fudan University
Shanghai, Jiangsu, China
China, Shaanxi
Xijing Hospital
Xian, Shaanxi, China
China
Tiangjin People's Hospital
Tianjin, China
Sponsors and Collaborators
VanWorld Pharmaceutical (Rugao) Company Limited
Investigators
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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
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Responsible Party: VanWorld Pharmaceutical (Rugao) Company Limited
ClinicalTrials.gov Identifier: NCT02168010    
Other Study ID Numbers: vw1401
First Posted: June 19, 2014    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: August 2014
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Neurotropin
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants