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NCT05126901 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Shield Therapeutics.

Completed
Registry status
Phase 3
Development phase
65
Enrollment target

NCT05126901 is a Phase 3 study that has completed, run by Shield Therapeutics. The registered enrollment target is 65 participants.

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The verdict

NCT05126901, a Phase 3 study, has completed, sponsored by Shield Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
65 participants
Enrollment target

Study 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.

Interventions

  • DRUG Ferrous sulfate
  • DRUG Ferric Maltol

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2021-11-03
Est. Completion 2024-06-09
Phase Phase 3

Sponsor

Shield Therapeutics

4 total trials

What the Registry Record Tells You About NCT05126901

The ClinicalTrials.gov registry entry for NCT05126901 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shield Therapeutics, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Ferrous sulfate is the first listed.

NCT05126901 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05126901 about?

NCT05126901 is a clinical study titled "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". 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 ...

What is the current status of trial NCT05126901?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 65 participants. The study started on 2021-11-03. Estimated completion is 2024-06-09.

What interventions are being tested in trial NCT05126901?

The interventions under investigation include: Ferrous sulfate (DRUG), Ferric Maltol (DRUG).

Who is sponsoring clinical trial NCT05126901?

This trial is sponsored by Shield Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.