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Iron Oligosaccharide in Inflammatory Bowel Disease Subjects With Iron Deficiency Anaemia

NCT01017614 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2012-11-27

No results posted yet for this study

Summary

The purpose of the trial is to demonstrate that intravenous iron oligosaccharide is non-inferior to oral iron sulphate in reducing iron deficiency anaemia secondary to inflammatory bowel disease (IBD), evaluated as the ability to increase haemoglobin (Hb).

Conditions

Interventions

DRUG

Monofer

* administered as intravenous infusions (A1)repeated weekly until total iron repletion is obtained * administered as intravenous bolus injections (A2)as repeated bolus injections weekly until total iron repletion is obtained

DRUG

Iron Sulphate

200 mg daily

Sponsors & Collaborators

  • Max Neeman International

    collaborator UNKNOWN

  • Pharmacosmos A/S

    lead INDUSTRY

Principal Investigators

  • Pharmacosmos A/S · Pharmacosmos A/S, Roervangsvej 30, DK 4300 Holbaek, Denemark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-07-31
Completion
2012-08-31

Countries

  • Denmark
  • India
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01017614 on ClinicalTrials.gov