drugset / Trial / NCT05126901
Evaluate the Safety and Efficacy of Ferric Maltol Oral Suspension vs. Ferrous Sulfate Oral Liquid in Children and Adolescents Aged 2 to 17 Years With Iron-deficiency Anaemia, With a Single Arm Study in Infants Aged 1 Month to Less Than 2 Years
RandomizedParallel-groupOpen-labelTreatment
Summary
The objective of the study is to compare the safety and gastrointestinal tolerability of ferric maltol oral suspension and ferrous sulfate oral liquid in children and adolescents aged 2 years to 17 years, and assess the safety and tolerability of ferric maltol oral suspension in children 1 month to less than 2 years, in the treatment of iron deficiency anaemia during the 12 weeks treatment period.
Timeline
- Start
- 2021-11-03
- Primary completion
- 2024-06-09
- Completion
- 2024-06-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ferric maltol | Small molecule | 0.1 unknown | Oral |
| Subject | Ferric maltol | Small molecule | 2.5 ml | Oral |
| Subject | Ferric maltol | Small molecule | 5 ml | Oral |
| Comparator | Ferrous Sulfate | Diagnostic / imaging agent | 6 mg/kg | Oral |