Iron Substitution After Upper Gastro-Intestinal Bleeding

Anemia Clinical Trial

Official title:

Comparison of the Efficacy of Compliant Oral Iron Treatment (FerroDuretter ®) for 3 Months After Discharge Versus Single-dose of Intravenous Iron (Ferinject ®) Before Discharge in Patients With Acute Bleeding From Upper Gastrointestinal Tract. A Double Blinded Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00978575
• Other study ID #: Iron Gab
• Status: Completed
• Phase: Phase 4
• First received: September 16, 2009
• Last updated: April 4, 2013
• Start date: April 2010
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The trial is a double-blind randomized trial designed to examine whether compliant iron therapy (intravenous or oral) for 3 months after discharge increases hemoglobin levels more and faster than no treatment - in patients with acute bleeding from upper gastrointestinal tract. The trial will include 126 patients at Aarhus University Hospital. In addition to efficacy assessment quality of life assessment and health economic calculations between the treatments will be compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: April 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Acute upper gastrointestinal bleeding

• Anemia

Exclusion Criteria:

• Liver disease

• Terminal cancer

• Kidney disease

• variceal bleeding

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Gastrointestinal Hemorrhage

Intervention

Drug:
• ferricarboxymaltose
Single dose of maximum 1000 mg ferricarboxymaltose intravenous
• Ferrosulfate
200mg daily for 12 weeks
• Placebo
100 mg isotonic sodium and 2 placebo tablets daily

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	GCP-unit at Aarhus University Hospital, Aarhus, Denmark, Vifor Pharma

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	haemoglobin		13 weeks	Yes
Secondary	Quality of life Health economics		13 weeks, 6 and 12 months	No