Ferric Carboxymaltose Treatment to Improve Fatigue Symptoms in Iron-deficient Non-anaemic Women of Child Bearing Age (Prefer)
This study has been completed.
Information provided by (Responsible Party):
First received: April 22, 2010
Last updated: November 13, 2012
Last verified: November 2012
research study of Ferric carboxymaltose to treat fatigue/exhaustion symptoms, believed to be due to iron deficiency.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Vifor Inc.:
Primary Outcome Measures:
- To assess the efficacy of a single intravenous (IV) administration of FCM (1,000 mg) compared with placebo in improving fatigue symptoms in IDNA women of child bearing age. [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To compare efficacy of a single IV application of FCM with that of placebo on change of iron status on Day 56 (i.e., proportion of subjects with haemoglobin (Hb) ≥12 g/dL; serum-ferritin (s-ferritin) ≥50 ng/mL; transferrin saturation (TfS) >20%). [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
- To determine the relationship between change in iron status (s-ferritin and TfS) and improvement of fatigue symptoms. [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
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 Name: Ferinject
|Placebo Comparator: Saline||
Placebo patients will be administered 250 mL normal saline for intravenous drip over a minimum of 15 minutes.
Other Name: Saline
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