A randomized, double-blind, placebo-controlled phase III trial of duloxetine in Japanese fibromyalgia patients.

ABSTRACT:

Introduction

Fibromyalgia is characterized by widespread pain and is often accompanied by accessory symptoms. There are limited treatment options for this condition in Japan. Therefore, we conducted a phase III study to assess the efficacy and safety of duloxetine in Japanese patients with fibromyalgia.

Methods

This randomized, double-blind, placebo-controlled, parallel-group trial was conducted in Japan. Outpatients who met the American College of Rheumatology 1990 criteria for fibromyalgia and whose Brief Pain Inventory (BPI) average pain score was ≥4 were randomized to duloxetine 60 mg or placebo once daily for 14 weeks. The primary efficacy measure was the change in the BPI average pain score from baseline. Secondary efficacy, quality of life (QoL), and safety outcomes w

SUBMITTER: Murakami M 

PROVIDER: S-EPMC4546310 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature