Iron Replacement in Oesophagogastric Neoplasia

NCT01927328 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-10-28

No results posted yet for this study

Summary

40 eligible patients with confirmed esophageal or gastric adenocarcinoma and anemia will be randomized to a control or intervention group for management of this anemia. The control group treatment will consist of standard treatments as governed by the clinical team (eg oral iron, blood transfusions) whilst the intervention group will be treated with intravenous iron III isomaltoside (Monofer ®).

It is hypothesized that intravenous iron supplementation is more efficacious than standard therapies.

Conditions

Interventions

DRUG

Iron isomaltoside 1000

Sponsors & Collaborators

  • Pharmacosmos A/S

    collaborator INDUSTRY
  • Nottingham University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Barrie D Keeler, FRCS · University of Nottingham

  • Austin G Acheson, MD FRCS · University of Nottingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • United Kingdom

Study Locations

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Entities

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 NCT01927328 on ClinicalTrials.gov