Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD
NCT02680756 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250
Last updated 2020-11-02
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).
Conditions
- Anemia, Iron-Deficiency
- Inflammatory Bowel Disease
- Crohn's Disease
Interventions
- DRUG
-
Ferric Maltol
- DRUG
-
Ferric Carboxy Maltose
Sponsors & Collaborators
-
Shield Therapeutics
lead INDUSTRY
Principal Investigators
-
Jackie Mitchell, PhD · Shield Therapeutics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-31
- Primary Completion
- 2018-10-31
- Completion
- 2019-01-31
Countries
- United States
- Belgium
- France
- Germany
- Hungary
- Spain
Study Locations
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