drugset / Trial / NCT01017614

Iron Oligosaccharide in Inflammatory Bowel Disease Subjects With Iron Deficiency Anaemia

NCT01017614

Phase 3 Completed 350 enrolled Pharmacosmos A/S Max Neeman International · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the trial is to demonstrate that intravenous iron oligosaccharide is non-inferior to oral iron sulphate in reducing iron deficiency anaemia secondary to inflammatory bowel disease (IBD), evaluated as the ability to increase haemoglobin (Hb).

Timeline

Start
2009-10
Primary completion
2012-07
Completion
2012-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Iron Sulfate Small molecule 200 mg Oral
Subject Iron isomaltoside 1000 Unknown Intravenous