Efficacy and safety of short-term use of a pelubiprofen CR and aceclofenac in patients with symptomatic knee osteoarthritis: A double-blinded, randomized, multicenter, active drug comparative, parallel-group, phase IV, non-inferiority clinical trial.

ABSTRACT:

Introduction

At present, information about clinical efficacy and adverse events of controlled release (CR) form of pelubiprofen, a prodrug of 2-arylopropionic acid with relatively selective effects on cyclooxygenase-2 activity, remains scarce. In this study, we sought to determine non-inferiority of pelubiprofen CR 90 mg/day compared to aceclofenac 200 mg/day regarding clinical efficacy and adverse events after a 4-week course of medication in the patients with symptomatic knee osteoarthritis.

Materials and methods

A total of 191 patients were randomly assigned to take either pelubiprofen CR 90 mg (n = 95) or aceclofenac 200 mg (n = 96). The primary outcome variable was non-inferiority of pain reduction between baseline and week 4 when assessed using a 100 mm pain visual ana

SUBMITTER: Shin JY 

PROVIDER: S-EPMC7523996 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature