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Analgecine for Treatment of Low Back Pain

NCT ID: NCT02168010

Last Updated: 2015-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

584 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-07-31

Brief Summary

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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

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experiment

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

Group Type EXPERIMENTAL

Analgecine

Intervention Type DRUG

Analgesic drug under test

PosCtrl

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

Group Type ACTIVE_COMPARATOR

Neurotropin

Intervention Type DRUG

Analgesic drug as positive control

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Blank tablet as placebo.

Interventions

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Analgecine

Analgesic drug under test

Intervention Type DRUG

Neurotropin

Analgesic drug as positive control

Intervention Type DRUG

Placebo

Blank tablet as placebo.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VanWorld Pharmaceutical (Rugao) Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steve Chen-Lung Lin, MD, PhD

Role: STUDY_DIRECTOR

Graduate School of Medicine, Kaohsiung Medical University

Jian Dong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhong Shan Hospital, Fudan University

Locations

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Second Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

No.3 Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

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

Wuhan, Hubei, China

Site Status

Shanghai Sixth People's Hosptial

Shanghai, Jiangsu, China

Site Status

Zhong Shan Hospital, Fudan University

Shanghai, Jiangsu, China

Site Status

Xijing Hospital

Xi'an, Shaanxi, China

Site Status

Tiangjin People's Hospital

Tianjin, , China

Site Status

Countries

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China

Other Identifiers

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vw1401

Identifier Type: -

Identifier Source: org_study_id