A Study For Pregabalin In Patients With Fibromyalgia

Summary

The purpose of this study is to evaluate the efficacy and tolerability of pregabalin compared with placebo for management of fibromyalgia in adults.

Timeline

Start

2012-02-06

Primary completion

2016-10-31

Completion

2016-10-31

Outcome

Met primary endpoint

registry analysis (unspecified test); Pregabalin vs Placebo; p = 0.0001; Mean Difference (Final Values) -0.730 (95% CI -1.10 to -0.36) NCT01387607 ↗

paper A significant reduction from baseline to Week 14 in weekly MPS was seen for patients treated with pregabalin (n=170) versus placebo (n=164) PMID 33658841 ↗

Publications

• Zhang X, Xu H, Zhang Z, Li Y, Pauer L, Liao S, Zhang F. Efficacy and Safety of Pregabalin for Fibromyalgia in a Population of Chinese Subjects. J Pain Res. 2021 Feb 25;14:537-548. doi: 10.2147/JPR.S281483. eCollection 2021.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pregabalin	Small molecule	300 mg	—
Subject	Pregabalin	Small molecule	450 mg	—

Indications