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Iron Substitution After Upper Gastro-Intestinal Bleeding

This study has been completed.
Sponsor:
Collaborators:
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
Vifor Pharma
Information provided by (Responsible Party):
Palle Bager, University of Aarhus
ClinicalTrials.gov Identifier:
NCT00978575
First received: September 16, 2009
Last updated: April 4, 2013
Last verified: April 2013
History of Changes

September 16, 2009
April 4, 2013
April 2010
January 2013   (final data collection date for primary outcome measure)
haemoglobin [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
Haemglobin [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00978575 on ClinicalTrials.gov Archive Site
Quality of life Health economics [ Time Frame: 13 weeks, 6 and 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Iron Substitution After Upper Gastro-Intestinal Bleeding
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

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Gastrointestinal Hemorrhage
  • Anemia
  • Drug: ferricarboxymaltose
    Single dose of maximum 1000 mg ferricarboxymaltose intravenous
    Other Name: Ferinject
  • Drug: Ferrosulfate
    200mg daily for 12 weeks
    Other Name: FerroDuretter
  • Drug: Placebo
    100 mg isotonic sodium and 2 placebo tablets daily
  • Active Comparator: Intravenous iron
    Intervention: Drug: ferricarboxymaltose
  • Active Comparator: Oral iron
    Intervention: Drug: Ferrosulfate
  • Placebo Comparator: Isotonic Sodium and placebo tablets
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
97
April 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Acute upper gastrointestinal bleeding
  • Anemia

Exclusion Criteria:

  • Liver disease
  • Terminal cancer
  • Kidney disease
  • variceal bleeding
  • Pregnancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00978575
Iron Gab
Yes
Palle Bager, University of Aarhus
University of Aarhus
  • GCP-unit at Aarhus University Hospital, Aarhus, Denmark
  • Vifor Pharma
Study Chair: Hendrik Vilstrup, Professor Aarhus University Hospital
University of Aarhus
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP