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.
Conditions
Interventions
Trade Name: TARDYFERON
Pharmaceutical Form: Tablet
INN or Proposed INN: Ferrous sulphate
Other descriptive name: 80
Concentration unit:
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Ambulatory, menstruated female who have reached the legal majority in their country with mild to moderate iron deficiency anaemia Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: anaemia with haemoglobin level 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;Main Objective: 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; Secondary Objective: 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 | — |
Countries
France
Outcome results
None listed