Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT02680756
Brief 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).
Detailed 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.
Study:
NCT02680756
Study Brief:
Protocol Section:
NCT02680756