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

• Conditions: Pregnant women with diagnosed iron deficiency; MedDRA version: 12.1Level: LLTClassification code 10022976Term: Iron deficiency anemia secondary to inadequate dietary iron intake

• Registration Number: EUCTR2010-018940-15-DE
• Lead Sponsor: SALUS Haus GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-09
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

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 < 20 µg/L determined at screening

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

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)/AspartateAminotransferase (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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified