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A Phase IV, multi-centre, randomized, open label study to investigate the efficacy and safety of Floradix® mit Eisen and ferro sanol® duodenal mite 50 mg in pregnant women with diagnosed iron deficiency

A Phase IV, multi-centre, randomized, open label study to investigate the efficacy and safety of Floradix® mit Eisen and ferro sanol® duodenal mite 50 mg in pregnant women with diagnosed iron deficiency

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-018940-15-DE
Enrollment
Unknown
Registered
2010-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2015-07-10

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

Conditions

Pregnant women with diagnosed iron deficiency MedDRA version: 12.1 Level: LLT Classification code 10022976 Term: Iron deficiency anemia secondary to inadequate dietary iron intake

Interventions

Trade Name: Floradix mit Eisen Pharmaceutical Form: Oral solution CAS Number: 299-29-6 Other descriptive name: FERROUS GLUCONATE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: r

Sponsors

SALUS Haus GmbH & Co. KG
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Females who are = 18 years old 2. Confirmed singleton pregnancy 3. Pregnancy at = 23rd and = 26th week 4. Iron deficiency diagnosed before screening 5. Haemoglobin = 9,5 g/dl and = 11,2 g/dl determined at screening 6. Ferritin =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Iron deficiency which is not pregnancy related 2. High-risk pregnancy 3. Anaemia which is not caused by iron deficiency 4. Haemochromatosis or haemosiderosis 5. Myelodysplastic syndromes 6. Malignancies treated with chemotherapy or radiotherapy within the last 12 months 7. Gastritis or gastroduodenal ulcer 8. Known serious concomitant illness: e.g. autoimmune diseases, rheumatoid arthritis, diabetes mellitus 9. Known hypothyroidism 10. Known hepatitis B, hepatitis C, or HIV infection 11. Advanced renal insufficiency (creatinine > 2,2 mg/100 ml) 12. Advanced hepatic insufficiency (Serum Glutamic Oxaloacetic Transaminase (SGOT)/Aspartate Aminotransferase (AST); Serum Glutamic PyruvicTransaminase (SGPT)/Alanine Aminotransferase (ALT) > 2,5 x upper normal value) 13. Transplant patients 14. Any other treatment of iron deficiency during study participation (e.g. intravenous iron preparations)

Design outcomes

Primary

MeasureTime frame
Main Objective: To gather information on the efficacy and safety profile of a long-term treatment with Floradix® mit Eisen and to compare descriptively against a treatment with ferro sanol® duodenal mite 50mg;Secondary Objective: -;Primary end point(s): The primary efficacy endpoint is the haemoglobin baseline change.—

Countries

Germany

Outcome results

None listed

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