Iron Oligosaccharide in Inflammatory Bowel Disease Subjects With Iron Defic... | Completed
Iron Oligosaccharide in Inflammator... | Completed
Iron Oligosaccharide in Inflammatory Bowel Disease Subjects With Iron Deficiency Anaemia

Trial Source

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Medical Conditions
  • Inflammatory Bowel Disease
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01017614
Primary Trial ID Number

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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).
Research Details
  • The study is designed to determine the effects of an investigational drug Monofer in subjects with Inflammatory Bowel Disease (IBD) (an intestinal disease characterized by swelling, redness and sometimes ulcers in intestine) and with Iron Deficiency Anaemia (IDA) (Anaemia is a condition characterized by deficiency of blood in the body).
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : Monofer, Drug : Iron Sulphate

Study Arm Groups : Monofer, Iron Sulphate

Intervention Type
See Interventions above
Primary Outcome Measures
    Change in Hb concentration from baseline to week 8.; 8 weeks
Secondary Outcome Measures
    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
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
350
Participant Inclusion Criteria
    Inclusion Criteria:

    Subjects with a diagnosis of IBD with iron deficiency anaemia will be included if they meet all of the following criteria:

    1. Men and women, aged more than 18 years.

    2. 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).

    3. Hb <12.0 g/dL (7.45 mmol/L).

    4. Transferrin saturation (TfS) <20 %.

    Exclusion Criteria:

    1. Anaemia predominantly caused by other factors than iron deficiency anaemia.

    2. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis).

    3. Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulphate).

    4. Known hypersensitivity to any excipients in the investigational drug products.

    5. Subjects with a history of multiple allergies.

    6. Active Intestinal Tuberculosis.

    7. Active Intestinal amoebic infections.

    8. Decompensated liver cirrhosis and hepatitis (alanine aminotransferase (ALT) > 3 times upper limit normal).

    9. Acute infections (assessed by clinical judgement), supplied with white blood cells (WBC) and C-reactive protein (CRP)).

    10. Rheumatoid arthritis with symptoms or signs of active joint inflammation.

    11. Pregnancy and nursing

    12. Extensive active bleeding necessitating blood transfusion.

    13. Planned elective surgery during the study.

    14. Participation in any other clinical study within 3 months prior to screening.

    15. Intolerance to oral iron treatment.

    16. Untreated B12 or folate deficiency.

    17. Other I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit.

    18. Erythropoetin treatment within 8 weeks prior to screening visit.

    19. Diagnosis of Hepatitis B and/or C, confirmed by appropriate lab test.

    20. Any other medical condition that, in the opinion of Investigator, may cause the patient to be unsuitable for the completion of the study or place the patient at potential risk from being in the study. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.

    21. History of immunocompromise, including positive HIV test result
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Local Institution
London
Greater London
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Denmark, India, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Phase III, Randomized, Comparative, Open-label Study of Intravenous Iron Oligosaccharide (Monofer®) Administered by Infusions or Repeated Bolus Injections in Comparison With Oral Iron Sulphate in Inflammatory Bowel Disease Subjects With Iron Deficiency Anaemia
EudraCT Number
Not available for this trial
Funder(s)
  • Max Neeman International
Other Study ID Numbers
P-Monofer-IBD-01
Sponsor(s)
Pharmacosmos A/S
Key Dates

Recruitment Start Date

Oct 2009

Recruitment End Date

Jul 2012

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

19 Nov 2009

Last Updated

22 Nov 2012