Analgecine for Treatment of Low Back Pain

VanWorld Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Low Back Pain

Treatments: Drug: Placebo; Drug: Neurotropin; Drug: Analgecine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02168010

vw1401

Details and patient eligibility

About

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.

Enrollment: 584 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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584 participants in 3 patient groups, including a placebo group

Experiment

Experimental group

Description:

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

Treatment:

Drug: Analgecine

PosCtrl

Active Comparator group

Description:

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

Treatment:

Drug: Neurotropin

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo