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NCT Number: NCT02168010

Analgecine for Treatment of Low Back Pain

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Second Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Analgecine

Drug

Analgesic drug under test

Neurotropin

Drug

Analgesic drug as positive control

Placebo

Drug

Blank tablet as placebo.

Primary outcomes

  1. Change of Visual Analysis Scale on Pain

    Time frame: Day 0, 7, 14 and 21

Secondary outcomes

  1. ECG

    Time frame: Day 0, 21

  2. Routine Hematology Testing

    Time frame: Day 0, 21

  3. Routine Urine Testing

    Time frame: Day 0, 21

  4. Renal / Liver function tests

    Time frame: Day 0, 21

  5. Degree of Improvement of Related Symptoms

    Time frame: Day 0, 7, 14, 21

Sponsors and collaborators

Lead sponsor

VanWorld Pharmaceutical (Rugao) Company Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 19, 2014
Registry last updated
Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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