NCT01110356

Ferric Carboxymaltose Treatment to Improve Fatigue Symptoms in Iron-deficient Non-anaemic Women of Child Bearing Age

A Multicentre Randomised Placebo-controlled Study to Assess the Efficacy and Safety of a Single Administration of Ferric Carboxymaltose in Improving Fatigue Symptoms in Iron-deficient Non-anaemic Women of Child Bearing Age

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 294 (actual)
• Sponsor: Vifor Pharma · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

research study of Ferric carboxymaltose to treat fatigue/exhaustion symptoms, believed to be due to iron deficiency.

Conditions

• Iron Deficiency

Interventions

Type	Name	Description
DRUG	Ferinject	Ferric carboxymaltose will be provided in 2 vials of 10 mL containing each 500 mg iron, which will be diluted in 250 mL normal saline for injection. Study drug will be administered by drip infusion immediately after preparation over a minimum of 15 minutes. Placebo patients will be administered 250 mL normal saline for injection over a minimum of 15 minutes.
OTHER	Saline	Placebo patients will be administered 250 mL normal saline for intravenous drip over a minimum of 15 minutes.

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-10-01
• Completion: 2012-10-01
• First posted: 2010-04-26
• Last updated: 2012-11-15

Locations

1 site across 1 country: Austria