drugset / Trial / NCT00978575
Iron Substitution After Upper Gastro-Intestinal Bleeding
Phase 4
Completed
97 enrolled
University of Aarhus
GCP-unit at Aarhus University Hospital, Aarhus, Denmark · collabVifor Pharma · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2010-04
- Primary completion
- 2013-01
- Completion
- 2013-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ferric carboxymaltose | Other / unclassified | 1000 mg | Intravenous |
| Comparator | Ferrosulfate | Unknown | 200 mg | Oral |