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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00978575
Other study ID # Iron Gab
Secondary ID
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


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
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