Last updated on June 2018

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


Brief description of study

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).

Detailed Study Description

A phase 3b, randomized, controlled, multicentre study with oral ferric maltol or intravenous iron (FCM), for the treatment of iron deficiency anaemia in subjects with inflammatory bowel disease.

Approximately 242 eligible subjects will be randomised (1:1) to receive one of the following treatments for the duration of the study treatment period (52 weeks):

  • Oral ferric maltol, 30 mg capsule bid.
  • Intravenous iron (ferric carboxy maltose) as per SPC

In the FCM arm IV iron treatment will be repeated if the subject is iron deficient at any of the study visits.

Subject participation in the study will consist of 3 periods:

  • Screening: Up to 14 days
  • Randomised Treatment: 52 weeks
  • Post-treatment safety follow-up: 14 days after study medication discontinuation

Primary efficacy and safety of ferric maltol and Intravenous iron (ferric carboxy maltose) will be evaluated after the first 12 weeks.

End of study evaluations will occur at Week 52 or premature discontinuation.

Clinical Study Identifier: NCT02680756

Contact Investigators or Research Sites near you

Start Over

Mark Sampson, MBChB

Dothan, AL United States
  Connect »

Mark Sampson, MBChB

Tucson, AZ United States
  Connect »

Mark Sampson, MBChB

Gainesville, FL United States
  Connect »

Mark Sampson, MBChB

Hollywood, FL United States
  Connect »

Mark Sampson, MBChB

Miami, FL United States
  Connect »

Mark Sampson, MBChB

Chevy Chase, MD United States
  Connect »

Mark Sampson, MBChB

Saint Paul, MN United States
  Connect »

Mark Sampson, MBChB

Saint Louis, MO United States
  Connect »

Mark Sampson, MBChB

Great Neck, NY United States
  Connect »

Mark Sampson, MBChB

Fargo, ND United States
  Connect »

Mark Sampson, MBChB

Lima, OH United States
  Connect »

Mark Sampson, MBChB

Germantown, TN United States
  Connect »

Mark Sampson, MBChB

Nashville, TN United States
  Connect »

Mark Sampson, MBChB

Beaumont, TX United States
  Connect »

Mark Sampson, MBChB

Houston, TX United States
  Connect »

Mark Sampson, MBChB

San Antonio, TX United States
  Connect »

Mark Sampson, MBChB

Bountiful, UT United States
  Connect »

Mark Sampson, MBChB

Charlottesville, VA United States
  Connect »

Mark Sampson, MBChB

Bellevue, WA United States
  Connect »

Mark Sampson, MBChB

Seattle, WA United States
  Connect »

Mark Sampson, MBChB

Saint Etienne, France
  Connect »

Mark Sampson, MBChB

Frankfurt am Main, Germany
  Connect »

Mark Sampson, MBChB

Schweinfurt, Germany
  Connect »

Mark Sampson, MBChB

San Sebastian, Spain
  Connect »

Mark Sampson, MBChB

Santiago de Compostela, Spain
  Connect »

Mark Sampson, MBChB

Vandœuvre-lès-Nancy, France
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.