NCT01017614

Brief 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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2009

Typical duration for phase_3

Geographic Reach
3 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

November 27, 2012

Status Verified

November 1, 2012

Enrollment Period

2.8 years

First QC Date

November 19, 2009

Last Update Submit

November 22, 2012

Conditions

Inflammatory Bowel Disease

Keywords

Inflammatory Bowel DiseaseIron deficiencyIron deficiency anaemiaAnaemia

Outcome Measures

Primary Outcomes (1)

  • Change in Hb concentration from baseline to week 8.

    8 weeks

Secondary Outcomes (1)

  • Number of subjects who achieve target limits of Hb (men 13-18 g/dL, women 12-16 g/dL) and have change in Hb concentration > 1.0 g/dL and have serum ferritin (100-800µg/L) and have achieved Transferrin saturation (TfS) (20-50 %) at week 2, 4 and 8.

    8 weeks

Study Arms (2)

Monofer

EXPERIMENTAL

* administered as intravenous infusions (A1) * administered as intravenous bolus injections (A2)

Drug: Monofer

Iron Sulphate

ACTIVE COMPARATOR

tablets administered orally

Drug: Iron Sulphate

Interventions

MonoferDRUG

* 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

Monofer
Iron SulphateDRUG

200 mg daily

Iron Sulphate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with a diagnosis of IBD with iron deficiency anaemia will be included if they meet all of the following criteria:
  • Men and women, aged more than 18 years.
  • Subjects diagnosed with inflammatory bowel disease and mild to moderate disease activity (defined as a score of less than or equal to 5 on the Harvey-Bradshaw index for Crohn's disease and a Mayo score (subscore without endoscopy) of less than or equal to 6 for ulcerative colitis).
  • Hb \<12.0 g/dL (7.45 mmol/L).
  • Transferrin saturation (TfS) \<20 %.

You may not qualify if:

  • Anaemia predominantly caused by other factors than iron deficiency anaemia.
  • Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis).
  • Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulphate).
  • Known hypersensitivity to any excipients in the investigational drug products.
  • Subjects with a history of multiple allergies.
  • Active Intestinal Tuberculosis.
  • Active Intestinal amoebic infections.
  • Decompensated liver cirrhosis and hepatitis (alanine aminotransferase (ALT) \> 3 times upper limit normal).
  • Acute infections (assessed by clinical judgement), supplied with white blood cells (WBC) and C-reactive protein (CRP)).
  • Rheumatoid arthritis with symptoms or signs of active joint inflammation.
  • Pregnancy and nursing
  • Extensive active bleeding necessitating blood transfusion.
  • Planned elective surgery during the study.
  • Participation in any other clinical study within 3 months prior to screening.
  • Intolerance to oral iron treatment.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Research Site

Aalborg, Denmark

Location

Research Site

Aarhus, Denmark

Location

Research Site

Copenhagen, Denmark

Location

Research Site

Hyderabad, India

Location

Research Site

Jaipur, India

Location

Research Site

Mumbai, India

Location

Research Site

Nashik, India

Location

Research Site

New Delhi, India

Location

Research Site

Pune, India

Location

Research Site

London, United Kingdom

Location

MeSH Terms

Conditions

Inflammatory Bowel DiseasesIron DeficienciesAnemia, Iron-DeficiencyAnemia

Interventions

Iron-Dextran Complex

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesAnemia, HypochromicHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDextransGlucansPolysaccharidesCarbohydrates

Study Officials

  • Pharmacosmos A/S

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 19, 2009

First Posted

November 20, 2009

Study Start

October 1, 2009

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

November 27, 2012

Record last verified: 2012-11

Locations

DK(3)IN(6)GB(1)