A Blinded, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of Ferric Carboxymaltose in Iron-Deficient Patients with Fibromyalgia.

ABSTRACT:

Introduction

This study sought to compare efficacy and safety of ferric carboxymaltose vs. placebo in iron-deficient patients with fibromyalgia.

Methods

This blinded, placebo-controlled, phase 2 study randomized adults with fibromyalgia and Revised Fibromyalgia Impact Questionnaire (FIQR) scores ≥ 60, ferritin levels < 0.05 µg/ml, and transferrin saturation < 20% (1:1) to receive ferric carboxymaltose [15 mg/kg (up to 750 mg)], or placebo (15 cc normal saline) intravenously on study days 0 and 5. Patients visited the clinic on days 14, 28, and 42 for efficacy and safety assessments. The primary efficacy endpoint was proportion of patients with a ≥ 13-point improvement from baseline to day 42 in FIQR scale score. Secondary endpoints included changes from baseline in FIQR scal

SUBMITTER: Boomershine CS 

PROVIDER: S-EPMC5935608 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature