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Prospective randomized study to assess the efficacy and tolerability of ferrimannitol ovoalbumin compared to ferrous sulphate in the treatment of iron deficiency anaemia

Prospective randomized study to assess the efficacy and tolerability of ferrimannitol ovoalbumin compared to ferrous sulphate in the treatment of iron deficiency anaemia

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-001510-40-ES
Enrollment
Unknown
Registered
2006-05-16
Start date
2005-07-12
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron deficiency anaemia

Interventions

Trade Name: Profer 40 mg Granulado Product Name: Profer 40 mg Granulado Pharmaceutical Form: Granules for oral solution INN or Proposed INN: ferrimannitol ovalbumin Concentration unit: mg milligram(s)

Sponsors

TEDEC MEIJI FARMA, S.A.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

Countries

Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026