Analgecine for Treatment of Low Back Pain

Low Back Pain Clinical Trial

Official title:

Efficacy and Safety of Analgecine for Low Back Pain: a Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02168010
• Other study ID #: vw1401
• Status: Completed
• Phase: Phase 3
• First received: June 17, 2014
• Last updated: December 8, 2015
• Start date: October 2013
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: VanWorld Pharmaceutical (Rugao) Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 584
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• Analgecine
Analgesic drug under test
• Neurotropin
Analgesic drug as positive control
• Placebo
Blank tablet as placebo.

Locations

Country	Name	City	State
China	Second Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	Shanghai Sixth People's Hosptial	Shanghai	Jiangsu
China	Zhong Shan Hospital, Fudan University	Shanghai	Jiangsu
China	No.3 Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Tiangjin People's Hospital	Tianjin
China	Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Xijing Hospital	Xian	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
VanWorld Pharmaceutical (Rugao) Company Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Visual Analysis Scale on Pain		Day 0, 7, 14 and 21	No
Secondary	ECG		Day 0, 21	Yes
Secondary	Routine Hematology Testing		Day 0, 21	Yes
Secondary	Routine Urine Testing		Day 0, 21	Yes
Secondary	Renal / Liver function tests		Day 0, 21	Yes
Secondary	Degree of Improvement of Related Symptoms		Day 0, 7, 14, 21	No