NCT02409459

Blinded Randomized Placebo-Controlled Study Efficacy and Safety of Injectafer in ID Patients With Fibromyalgia

A Blinded, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer (Ferric Carboxymaltose) in the Treatment of Iron Deficient Patients With Fibromyalgia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: American Regent, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study investigates the efficacy and safety of an IV iron Injectafer in the treatment of iron deficient patients with fibromyalgia. Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days 0 and 5. All treated subjects will be followed for efficacy and safety for 42 days.

Detailed description

This is a blinded, randomized, placebo-controlled study. All subjects who meet the inclusion requirements and no exclusion criteria will be entered into an up to 14 day screening phase. Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days 0 and 5. All treated subjects will be followed for efficacy and safety for 42 days. Subjects will visit the clinic on days 0 and 5 for treatment, and then on days 14, 28, and 42. The subject's participation in the study will be for approximately 42 days from day 0.

Conditions

• Iron Deficiency
• Fibromyalgia

Interventions

Type	Name	Description
DRUG	Injectafer
DRUG	Placebo	Normal saline solution

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-10-01
• Completion: 2016-03-01
• First posted: 2015-04-06
• Last updated: 2018-02-20
• Results posted: 2017-12-13

Locations

1 site across 1 country: United States