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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

Tracking Information
First Submitted Date  ICMJE June 17, 2014
First Posted Date  ICMJE June 19, 2014
Last Update Posted Date December 9, 2015
Study Start Date  ICMJE October 2013
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2014)
Change of Visual Analysis Scale on Pain [ Time Frame: Day 0, 7, 14 and 21 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2014)
  • ECG [ Time Frame: Day 0, 21 ]
  • Routine Hematology Testing [ Time Frame: Day 0, 21 ]
  • Routine Urine Testing [ Time Frame: Day 0, 21 ]
  • Renal / Liver function tests [ Time Frame: Day 0, 21 ]
  • Degree of Improvement of Related Symptoms [ Time Frame: Day 0, 7, 14, 21 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Analgecine for Treatment of Low Back Pain
Official Title  ICMJE Efficacy and Safety of Analgecine for Low Back Pain: a Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Drug: Analgecine
    Analgesic drug under test
  • Drug: Neurotropin
    Analgesic drug as positive control
  • Drug: Placebo
    Blank tablet as placebo.
Study Arms  ICMJE
  • Experimental: Experiment
    Test Drug Group: 2 times a day; 4 tablets per time (2 tablets of Analgecine and 2 tab. of placebo)
    Intervention: Drug: Analgecine
  • Active Comparator: PosCtrl
    PosCtrl: Positive Control Group. 2 times a day; 4 tablets / time (2 tab. of Neurotropin and 2 placebo tablets).
    Intervention: Drug: Neurotropin
  • Placebo Comparator: Placebo
    Placebo Group: 2 times a day; 4 tablets / time (4 placebo tablets).
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 8, 2014)
584
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2014)
600
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02168010
Other Study ID Numbers  ICMJE vw1401
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party VanWorld Pharmaceutical (Rugao) Company Limited
Study Sponsor  ICMJE VanWorld Pharmaceutical (Rugao) Company Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account VanWorld Pharmaceutical (Rugao) Company Limited
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP