Efficacy and Safety of Pregabalin for Fibromyalgia in a Population of Chinese Subjects.

ABSTRACT:

Purpose

Fibromyalgia (FM) may go underdiagnosed and untreated in China in part due to a lack of awareness and understanding of the condition, and limited available treatments.

Patients and methods

This randomized, double-blind, Phase III local registration trial compared the efficacy and safety of pregabalin (flexibly dosed 300-450 mg/day) versus placebo for the management of pain in Chinese adults diagnosed with FM according to American College of Rheumatology 1990 criteria, across 22 centers within China. Patients reported pain score of ≥40 mm on 100-mm scale (from 0 "no pain" to 100 "worst possible pain"). The primary efficacy endpoint was change from baseline to Week 14 in mean pain score (MPS). Secondary endpoints included measures of sleep and sleep interference. Safet

SUBMITTER: Zhang X 

PROVIDER: S-EPMC7920593 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature