Intravenous Ferric Carboxymaltose vs IV Iron Sucrose or IV Iron Dextran in Treating Iron Deficiency Anemia in Women

PHASE2CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

August 31, 2009

Primary Completion Date

March 31, 2013

Study Completion Date

August 31, 2013

Conditions
Iron Deficiency Anemia
Interventions
DRUG

Ferric Carboxymaltose (FCM)

One 500 mg dose at 100 mg/minute (Cohort I) or 750 mg dose at 100 mg/minute (Cohort II)

DRUG

Iron Sucrose / Iron Dextran

One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I), or a 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)

Trial Locations (1)

19403

Luitpold Pharmaceuticals, Inc., Norristown

Sponsors
All Listed Sponsors
lead

American Regent, Inc.

INDUSTRY