drugset / Trial / NCT01131624

Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) Versus Oral Iron for Iron Deficiency Anaemia in Pregnant Women

NCT01131624

Phase 3 Completed 252 enrolled Vifor Pharma Pierrel Research Europe GmbH · collab
RandomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to look at how well Ferric Carboxymaltose, an intravenous iron therapy (iron that is infused directly into your body through a vein), compares with ferrous sulphate capsules taken by mouth in the treatment of iron deficiency anaemia during pregnancy.

Timeline

Start
2010-05
Primary completion
2014-05
Completion
2015-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ferric carboxymaltose Other / unclassified 1000 mg Intravenous
Comparator Ferric carboxymaltose Other / unclassified 1500 mg Intravenous
Comparator Ferrous Sulfate Diagnostic / imaging agent 200 mg Oral

Indications