A Study of Duloxetine in Participants With Chronic Pain Due to Osteoarthritis in China

Summary

The purpose of this study is to assess the efficacy and safety of duloxetine once daily compared with placebo on the reduction of pain due to osteoarthritis (OA) in knee or hip in participants in China.

Timeline

Start

2013-09

Primary completion

2015-03

Completion

2015-06

Outcome

Met primary endpoint

paper Duloxetine-treated patients reported significant pain reduction, compared with placebo treatment, on the BPI 24-h Average Pain rating PMID 28043937 ↗

paper difference = -0.50 [-0.80, -0.20]; P = 0.001 PMID 28043937 ↗

Publications

• Leaney AA, Lyttle JR, Segan J, Urquhart DM, Cicuttini FM, Chou L, Wluka AE. Antidepressants for hip and knee osteoarthritis. Cochrane Database Syst Rev. 2022 Oct 21;10(10):CD012157. doi: 10.1002/14651858.CD012157.pub2.
• Yue L, Wang J, Enomoto H, Fujikoshi S, Alev L, Cheng YY, Skljarevski V. The Clinical Relevance of Pain Severity Changes: Is There Any Difference Between Asian and Caucasian Patients With Osteoarthritis Pain? Pain Pract. 2020 Feb;20(2):129-137. doi: 10.1111/papr.12835. Epub 2019 Nov 20.
• Wang G, Bi L, Li X, Li Z, Zhao D, Chen J, He D, Wang CN, Wu T, Duenas H, Skljarevski V, Yue L. Maintenance of effect of duloxetine in Chinese patients with pain due to osteoarthritis: 13-week open-label extension data. BMC Musculoskelet Disord. 2019 Apr 22;20(1):174. doi: 10.1186/s12891-019-2527-y.
• Yue L, Luo S, Wang Y, Wang CN, Duenas HJ, Skljarevski V. Clinical meaningfulness of duloxetine's effect in Chinese patients with chronic pain due to osteoarthritis: post hoc analyses of a phase 3 randomized trial. Open Access Rheumatol. 2019 Mar 21;11:67-76. doi: 10.2147/OARRR.S193044. eCollection 2019.
• Wang G, Bi L, Li X, Li Z, Zhao D, Chen J, He D, Wang CN, Duenas H, Skljarevski V, Yue L. Efficacy and safety of duloxetine in Chinese patients with chronic pain due to osteoarthritis: a randomized, double-blind, placebo-controlled study. Osteoarthritis Cartilage. 2017 Jun;25(6):832-838. doi: 10.1016/j.joca.2016.12.025. Epub 2016 Dec 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Duloxetine	Small molecule	60 mg	Oral

Indications