Analgecine for Treatment of Low Back Pain | NCT02168010

Studies
Analgecine for Treatment of Low Back Pain

NCT02168010

Sponsor

VanWorld Pharmaceutical (Rugao) Company Limited

Status

Completed

Last Update Posted

Dec 9, 2015Estimated

Enrollment

584Actual

Phase

Phase 3

Conditions

Low Back Pain

Interventions

Analgecine
Neurotropin
Placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Jun 17, 2014

First Submission Date that Met QC Criteria

Jun 17, 2014

First Posted Date

Jun 19, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2015

Last Update Posted Date

Dec 9, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

584Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Analgecine	Drug	Analgesic drug under test	Experiment
Neurotropin

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

Measure	Description	Time Frame
ECG		Day 0, 21
Routine Hematology Testing		Day 0, 21
Routine Urine Testing

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Second Hospital of Sun Yat-sen University		Guangzhou	Guangdong		China
No.3 Hospital of Hebei Medical University

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms