Clinical trial NCT02168010: Analgecine for Treatment of Low Back Pain
Official title: Efficacy and Safety of Analgecine for Low Back Pain: a Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Lead sponsor: VanWorld Pharmaceutical (Rugao) Company Limited
Sponsor class: INDUSTRY
First posted: 2014-06-19
Enrollment: 584
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change of Visual Analysis Scale on Pain
timeFrame: Day 0, 7, 14 and 21
Secondary outcomes:
measure: ECG
timeFrame: Day 0, 21
measure: Routine Hematology Testing
timeFrame: Day 0, 21
measure: Routine Urine Testing
timeFrame: Day 0, 21
measure: Renal / Liver function tests
timeFrame: Day 0, 21
measure: Degree of Improvement of Related Symptoms
timeFrame: Day 0, 7, 14, 21
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Second Hospital of Sun Yat-sen University
state: Guangdong
city: Shijiazhuang
country: China
facility: No.3 Hospital of Hebei Medical University
state: Hebei
city: Wuhan
country: China
facility: Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Shanghai
country: China
facility: Shanghai Sixth People's Hosptial
state: Jiangsu
city: Shanghai
country: China
facility: Zhong Shan Hospital, Fudan University
state: Jiangsu
city: Xian
country: China
facility: Xijing Hospital
state: Shaanxi
city: Tianjin
country: China
facility: Tiangjin People's Hospital
Study officials:
affiliation: Graduate School of Medicine, Kaohsiung Medical University
name: Steve Chen-Lung Lin, MD, PhD
role: STUDY_DIRECTOR
affiliation: Zhong Shan Hospital, Fudan University
name: Jian Dong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: