Iron Oligosaccharide in Inflammatory Bowel Disease Subjects With Iron Deficiency Anaemia
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ClinicalTrials.gov Identifier: NCT01017614 |
Recruitment Status
:
Completed
First Posted
: November 20, 2009
Last Update Posted
: November 27, 2012
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Inflammatory Bowel Disease | Drug: Monofer Drug: Iron Sulphate | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 350 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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 |
Study Start Date : | October 2009 |
Actual Primary Completion Date : | July 2012 |
Actual Study Completion Date : | August 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Monofer
|
Drug: Monofer
|
Active Comparator: Iron Sulphate
tablets administered orally
|
Drug: Iron Sulphate
200 mg daily
|
- Change in Hb concentration from baseline to week 8. [ Time Frame: 8 weeks ]
- 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. [ Time Frame: 8 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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 %.
Exclusion Criteria:
- 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.
- Untreated B12 or folate deficiency.
- Other I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit.
- Erythropoetin treatment within 8 weeks prior to screening visit.
- Diagnosis of Hepatitis B and/or C, confirmed by appropriate lab test.
- 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.
- History of immunocompromise, including positive HIV test result

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01017614
Denmark | |
Research Site | |
Aalborg, Denmark | |
Research Site | |
Copenhagen, Denmark | |
Research Site | |
Århus, Denmark | |
India | |
Research Site | |
Hyderabad, India | |
Research Site | |
Jaipur, India | |
Research Site | |
Mumbai, India | |
Research Site | |
Nasik, India | |
Research Site | |
New Delhi, India | |
Research Site | |
Pune, India | |
United Kingdom | |
Research Site | |
London, United Kingdom |
Study Chair: | Pharmacosmos A/S | Pharmacosmos A/S, Roervangsvej 30, DK 4300 Holbaek, Denemark |
Responsible Party: | Vice President, Clinical Development, Pharmacosmos A/S |
ClinicalTrials.gov Identifier: | NCT01017614 History of Changes |
Other Study ID Numbers: |
P-Monofer-IBD-01 EudraCT no 2009-012544-16 |
First Posted: | November 20, 2009 Key Record Dates |
Last Update Posted: | November 27, 2012 |
Last Verified: | November 2012 |
Keywords provided by Pharmacosmos A/S:
Inflammatory Bowel Disease Iron deficiency Iron deficiency anaemia Anaemia |
Additional relevant MeSH terms:
Anemia Intestinal Diseases Inflammatory Bowel Diseases Anemia, Iron-Deficiency Hematologic Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis |
Anemia, Hypochromic Iron Metabolism Disorders Metabolic Diseases Iron Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs |