EUCTR2010-018940-15-DE进行中（未招募）不适用
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
SALUS Haus GmbH & Co. KG0 个研究点开始时间: 2010年4月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •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
排除标准
- •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)
研究者
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