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NCT02680756 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD

A Phase 3 study of Crohn's Disease and Inflammatory Bowel Disease, sponsored by Shield Therapeutics.

Completed
Registry status
Phase 3
Development phase
250
Enrollment target
20
Study locations

NCT02680756 is a Phase 3 study of Crohn's Disease and Inflammatory Bowel Disease that has completed, run by Shield Therapeutics. The registered enrollment target is 250 participants, below the 2,412-participant average among 104 other Crohn's Disease trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT02680756, a Phase 3 study of Crohn's Disease and Inflammatory Bowel Disease, has completed, sponsored by Shield Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
250 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to compare the efficacy of ferric maltol and intravenous iron (IVI) Ferric Carboxy Maltose in the treatment of iron deficiency anaemia (IDA) and subsequent maintenance of haemoglobin in subjects with Inflammatory Bowel Disease (IBD).

Interventions

  • DRUG Ferric Maltol
  • DRUG Ferric Carboxy Maltose

Study Locations (20)

Texas

  • - Beaumont
  • - Houston
  • - San Antonio

Other

  • - Ghent
  • - Clichy
  • - Lille

Florida

  • - Gainesville
  • - Hollywood

Tennessee

  • - Germantown
  • - Nashville

Washington

  • - Bellevue
  • - Seattle

Alabama

  • - Dothan

Arizona

  • - Tucson

Maryland

  • - Chevy Chase

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2016-01
Est. Completion 2019-01
Phase Phase 3

Sponsor

Shield Therapeutics

4 total trials

What the Registry Record Tells You About NCT02680756

The ClinicalTrials.gov registry entry for NCT02680756 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,412-participant average among 104 other Crohn's Disease trials with a reported enrollment target (90% lower). The listed sponsor is Shield Therapeutics, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Crohn's Disease appearing as the primary indexed condition, and to 2 interventions - of which Ferric Maltol is the first listed.

NCT02680756 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Texas, Other, Florida.

Frequently Asked Questions

What is clinical trial NCT02680756 about?

NCT02680756 is a clinical study titled "Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD". The purpose of this study is to compare the efficacy of ferric maltol and intravenous iron (IVI) Ferric Carboxy Maltose in the treatment of iron deficiency anaemia (IDA) and subsequent maintenance of haemoglobin in subjects with Inflammatory Bowel Disease (IBD).

What is the current status of trial NCT02680756?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 250 participants. The study started on 2016-01. Estimated completion is 2019-01.

What conditions does trial NCT02680756 study?

This clinical trial studies the following conditions: Crohn's Disease, Inflammatory Bowel Disease, Anemia, Iron Deficiency.

What interventions are being tested in trial NCT02680756?

The interventions under investigation include: Ferric Maltol (DRUG), Ferric Carboxy Maltose (DRUG).

Who is sponsoring clinical trial NCT02680756?

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

Where is trial NCT02680756 being conducted?

This trial has 20 study locations across Alabama, Arizona, Florida, Maryland, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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