drugset / Trial / NCT03523117
Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of this study is to demonstrate the efficacy and safety of intravenous ferric carboxymaltose (FCM), compared to oral iron, in pediatric participants who have iron deficiency anemia.
Timeline
- Start
- 2019-01-31
- Primary completion
- 2020-12-22
- Completion
- 2021-01-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ferric carboxymaltose | Other / unclassified | 15 mg/kg | Intravenous |
| Comparator | Ferrous Sulfate | Diagnostic / imaging agent | 6 mg/kg | Oral |
| Comparator | Ferrous Sulfate | Diagnostic / imaging agent | 65 mg | Oral |