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

PHASE3CompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

November 3, 2021

Primary Completion Date

June 9, 2024

Study Completion Date

June 9, 2024

Conditions
AnemiaIron-deficiency
Interventions
DRUG

Ferric Maltol

"Ferric maltol oral suspension: 150 ml amber glass bottle with graduated syringe and adaptor. Oral suspension containing 30 mg elemental iron, in the form of 231.5 mg ferric maltol, in 5 ml suspension~Study dosage: The dose of ferric maltol oral suspension that will be administered for children aged 1 month to \< 2 yrs: 0.1 ml/kg BID, 2 to - 11 yrs: 2.5 ml BID, 12-17 yrs: 5 ml BID."

DRUG

Ferrous sulfate

"Ferrous sulfate 125 mg/ml (25 mg/ml elemental iron) oral liquid : 15 ml glass bottle.~Study dosage: For ferrous sulfate oral liquid, the dose administered will be for children and adolescents aged 2 years to 17 yrs: 6 mg/kg to the maximum of 4 ml BID."

Trial Locations (23)

17033

Penn State Hershey Children's Hospital, Hershey

28204

Levine Cancer Institute, Charlotte

33030

Homestead Research Institute, Homestead

33068

Eminent Clinical Research and Associates, North Lauderdale

33155

Miami Clinical Research, Miami

33165

Medical Research of Westcheste, Miami

34743

Kissimmee Clinical Research Corp, Kissimmee

36571

The Center for Clinical Trials, Saraland

77494

Zion Research, Katy

78539

BRCR Global Texas, Edinburg

83404

Clinical Research Prime, Idaho Falls

89106

Sierra Clinical Research, Las Vegas

98405

MultiCare Health System Institute for Research and Innovation, Tacoma

02903

Hasbro Children's Hospital, Providence

00907

BRCR Global Puerto, San Juan

CF14 4XW

Noah's Ark Children's Hospital for Wales, Cardiff

EH16 4TJ

Royal Hospital for Sick Children - Edinburgh, Edinburgh

LE1 5WW

Leicester Royal Infirmary, Leicester

Unknown

Alder Hey Children's NHS Foundation Trust, Liverpool

Newham University Hospital, London

SE5 9RS

King's College Hospital, London

M13 9WL

Royal Manchester Children's Hospital, Manchester

NG7 2UH

Nottingham University Hospitals, Nottingham

Sponsors
All Listed Sponsors
lead

Shield Therapeutics

INDUSTRY