Prospective randomized study to assess the efficacy and tolerability of ferrimannitol ovoalbumin compared to ferrous sulphate in the treatment of iron deficiency anaemia
- Conditions
- Iron deficiency anaemia
- Registration Number
- EUCTR2005-001510-40-ES
- Lead Sponsor
- TEDEC MEIJI FARMA, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Patients > 18 years old
Diagnosis of iron deficiency anaemia
Informed consent
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) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Anaemia not related with iron deficiency
Pregnancy and lactation
Diseases with iron overload
Patients who have received iron treatment within the previous 3 months prior to the inclusion in the study.
Digestive pathology that may cause intolerance or malabsortion
Hepatic insufficiency
Chronic pancreatitis
Renal insufficiency
AIDS or seropositive patients, infection, neoplasia or continuos haemorrhage
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy and tolerability of both study drugs in the treatment of iron deficiency anaemia;Secondary Objective: ;Primary end point(s): Recovery of the haematological parameters with or without clinical improvement
- Secondary Outcome Measures
Name Time Method