NCT01017614

Iron Oligosaccharide in Inflammatory Bowel Disease Subjects With Iron Deficiency Anaemia

A Phase III, Randomized, Comparative, Open-label Study of Intravenous Iron Oligosaccharide (Monofer®) Administered by Infusions or Repeated Bolus Injections in Comparison With Oral Iron Sulphate in Inflammatory Bowel Disease Subjects With Iron Deficiency Anaemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Pharmacosmos A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The study is designed to determine the effects of an investigational drug Monofer in subjects with Inflammatory Bowel Disease (IBD) (an intestinal disease characterized by swelling, redness and sometimes ulcers in intestine) and with Iron Deficiency Anaemia (IDA) (Anaemia is a condition characterized by deficiency of blood in the body).

Conditions

• Inflammatory Bowel Disease

Interventions

Type	Name	Description
DRUG	Monofer	* administered as intravenous infusions (A1)repeated weekly until total iron repletion is obtained * administered as intravenous bolus injections (A2)as repeated bolus injections weekly until total iron repletion is obtained
DRUG	Iron Sulphate	200 mg daily

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-07-01
• Completion: 2012-08-01
• First posted: 2009-11-20
• Last updated: 2012-11-27

Locations

10 sites across 3 countries: Denmark, India, United Kingdom