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Iron Substitution After Upper Gastro-Intestinal Bleeding

NCT00978575 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2013-04-05

No results posted yet for this study

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.

Conditions

  • Gastrointestinal Hemorrhage
  • Anemia

Interventions

DRUG

ferricarboxymaltose

Single dose of maximum 1000 mg ferricarboxymaltose intravenous

DRUG

Ferrosulfate

200mg daily for 12 weeks

DRUG

Placebo

100 mg isotonic sodium and 2 placebo tablets daily

Sponsors & Collaborators

  • GCP-unit at Aarhus University Hospital, Aarhus, Denmark

    collaborator OTHER

  • Vifor Pharma

    collaborator INDUSTRY

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Hendrik Vilstrup, Professor · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2013-01-31
Completion
2013-04-30

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00978575 on ClinicalTrials.gov