Select A Multi-centre Randomised Prospective Open-label Study to Investigate the Efficacy & Safety of a Standardised Correction Dosage Regimen of i.v. Ferric Carboxymaltose Versus Iron Sucrose for Treatment of Iron Deficiency Anaemia in Patients With Inflammatory Bowel Disease (FER-IBD-COR)

NCT00810030 Phase 3 COMPLETED

The purpose of this study is to determine how safe, tolerable and effective the new standardised dosage regimen of FERINJECT® infusions is, compared with a well established intravenous iron treatment.

Details

Lead sponsor	Vifor Pharma
Phase	Phase 3
Status	COMPLETED
Enrolment	484
Start date	2008-10
Completion	2010-04

Conditions

• Inflammatory Bowel Disease
• Anemia
• Iron Deficiency
• Iron-Deficiency Anemia
• Crohn's Disease
• Ulcerative Colitis

Interventions

• Ferric carboxymaltose
• Iron Sucrose

Primary outcomes

• Number of responders with respect to the baseline Hb value. — 12 weeks post baseline
  Number of responders (Hb increase ≥2 g/dL) with respect to the baseline Hb value.

Countries

Austria