E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Iron Deficiency Anaemia is a common pathology which concerns less than 5% of women aged 15 to 49 years old in the western countries but can affect up to 30% of the world population, knowing that 9 to 10 anaemic patients live in developing countries. Treating at least 3 months allows to normalize haemoglobin but it is important to carry on the iron treatment in order to fully replenish the iron stores.
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the study is to assess the efficacy of Tardyferon on serum ferritin and haemoglobin parameters. This will be appreciated by determining the percentage of patients reaching serum ferritin > or = 40 µg/l as well as the percentage of patients with haemoglobin > or = 12 g/dlin both groups of the randomized, placebo-controlled phase after 24 weeks of treatment |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to assess efficacy of Tardyferon on : - haemoglobin level at visit V4 - serum ferritin level at visit V4 - transferrin saturation at visit V4 - serum iron (changes levels) - serum transferrin receptors (changes levels) - QoL scores at 24 weeks - symptoms evolution at each visit - percentage of patients with Hb > or = 12g/dl and serum ferritin between 15 and 50 µg/l at visit V4 - compliance to the treatment |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Ambulatory, menstruated female who have reached the legal majority in their country with mild to moderate iron deficiency anaemia |
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E.4 | Principal exclusion criteria |
anaemia with haemoglobin level < 9g/dl or >11 g/dl Normocytic or macrocytic anaemia Normochromic or hyperchromic anaemia Normosideremic or hypersideremic anaemia Anaemia due to inflammatory disease, hemochromatosis, thalassemia, anaemia due to medullar insufficiency, refractory anaemia, chronic renal insufficiency |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of patients reaching haemoglobin > or = 12 g/dl and serum ferritin level equal or above 40 µg/l, will be compared in the two groups versus placebo of the randomized double-blind phase, after 24 weeks of treatment |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last patient |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |