CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 250 enrolled
Drug / intervention
Ferric Maltol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02680756
NCT02680756Phase 3Completed

A Phase 3b, Randomized, Controlled, Multicentre Study With Oral Ferric Maltol (Feraccru) or Intravenous Iron (Ferric Carboxy Maltose; FCM), for the Treatment of Iron Deficiency Anaemia in Subjects With Inflammatory Bowel Disease

Shield Therapeutics·interventional·Posted Feb 11, 2016·Updated Nov 2, 2020

In Brief

A Phase 3 clinical trial evaluating Ferric Maltol and Ferric Carboxy Maltose for Anemia, Iron-Deficiency and 2 related conditions. Completed, enrolled 250 participants across 44 sites in 6 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, France, Germany, Hungary, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 11, 2016
Enrollment StartJan 1, 2016
Primary CompletionOct 1, 2018
Study CompletionJan 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.4 years ago

Interventions

Ferric Maltoldrug

Ferric Carboxy Maltosedrug