Comparison of the Efficacy and Safety Profiles of a Pelubi Sustained Release Tab Versus a Pelubi Tab in Patients with Chronic Back Pain: A Randomized, Double-Blind, Multi-Institution Phase III Study

ABSTRACT

STUDY DESIGN: A randomized, double-blind, multi-institution, phase III study. OBJECTIVES: To evaluate the efficacy and safety of the Pelubi Sustained Release (SR) Tab in patients with chronic back pain, in comparison with the Pelubi Tab, whose efficacy has already been approved, a phase 3 clinical trial was conducted. SUMMARY OF LITERATURE REVIEW The Pelubi Tab Has shown clinical efficacy in patients with back pain. MATERIALS AND METHODS: From April 11, 2014 to July 24, 2014, 166 chronic back pain patients were recruited as subjects through a multi-institution, double-blind, random sample. We compared the experimental and control groups' clinical efficacy, which was estimated by the 100-mm Pain Visual Analog Scale (VAS) after 28 days of medication. We also compared the treatment efficacy of both drugs by using a variation of the Oswestry Disability Index (ODI) and Physician Global Assessment (PGA), with the total usage of relief medicine. The side effects and clinical pathology were also noted. RESULTS: Neither group showed a significant difference in 100-mm Pain VAS or ODI variation (p=0.1702, p=0.9041). There was no statistically significant difference between the experimental group and the control group in PGA or total usage of relief medicine. The ODI and PGA variation were not worse in the experimental group than the control group. The two groups showed no significant differences in side effects (p=0.9708). CONCLUSIONS: This study found that the Pelubi SR Tab applied to back pain patients was not inferior to the Pelubi Tab and did not show any significant difference in terms of safety. The Pelubi SR Tab can be used with the same expectation of safety as the Pelubi Tab.