Randomized, Double-blind, Placebo-controlled Phase III Trial of Duloxetine Monotherapy in Japanese Patients With Chronic Low Back Pain.

ABSTRACT:

Study design

A 14-week, randomized, double-blind, multicenter, placebo-controlled study of Japanese patients with chronic low back pain (CLBP) who were randomized to either duloxetine 60 mg once daily or placebo.

Objective

This study aimed to assess the efficacy and safety of duloxetine monotherapy in Japanese patients with CLBP.

Summary of background data

In Japan, duloxetine is approved for the treatment of depression, diabetic neuropathic pain, and pain associated with fibromyalgia; however, no clinical study of duloxetine has been conducted for CLBP.

Methods

The primary efficacy measure was the change in the Brief Pain Inventory (BPI) average pain score from baseline to Week 14. Secondary efficacy measures included BPI pain (worst pain, least pain, pain rig

SUBMITTER: Konno S 

PROVIDER: S-EPMC5113250 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature