A randomized, double-blind, placebo-controlled Phase III trial of duloxetine in Japanese patients with knee pain due to osteoarthritis.

ABSTRACT:

Purpose

To examine the efficacy and safety of duloxetine in Japanese patients with knee pain due to osteoarthritis.

Patients and methods

Patients were randomized to receive duloxetine 60 mg/day or placebo for 14 weeks in a double-blind manner (ClinicalTrials.gov Identifier: NCT02248480). The primary efficacy endpoint was mean change in Brief Pain Inventory pain severity (BPI-Severity) average pain. Secondary endpoints included improvement in other BPI-Severity scales, Patient Global Impression of Improvement, Clinical Global Impressions of Severity, health-related quality of life (HRQoL) scales, range of motion of the knee joint, safety and tolerability, and structural changes on X-ray images.

Results

Of the 354 randomized patients, 161 in the duloxetine group and 162

SUBMITTER: Uchio Y 

PROVIDER: S-EPMC5912377 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature