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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT no 2009-012544-16 |
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| Name | Class |
|---|---|
| Max Neeman International | UNKNOWN |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monofer | Experimental |
|
|
| Iron Sulphate | Active Comparator | tablets administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monofer | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hb concentration from baseline to week 8. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Subjects with a diagnosis of IBD with iron deficiency anaemia will be included if they meet all of the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pharmacosmos A/S | Pharmacosmos A/S, Roervangsvej 30, DK 4300 Holbaek, Denemark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aalborg | Denmark | ||||
| Research Site |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D000090463 | Iron Deficiencies |
| D018798 | Anemia, Iron-Deficiency |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D007505 | Iron-Dextran Complex |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003911 | Dextrans |
| D005936 | Glucans |
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| Iron Sulphate | Drug | 200 mg daily |
|
| Aarhus |
| Denmark |
| Research Site | Copenhagen | Denmark |
| Research Site | Hyderabad | India |
| Research Site | Jaipur | India |
| Research Site | Mumbai | India |
| Research Site | Nashik | India |
| Research Site | New Delhi | India |
| Research Site | Pune | India |
| Research Site | London | United Kingdom |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000747 | Anemia, Hypochromic |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |