CTRI/2011/11/002109已完成3 期
A multicentre, randomized, laboratory-blinded, parallel-group study to demonstrate the efficacy and tolerability of ferrous bisglycinate chelate in iron deficiency anaemia and to compare these with those of ferrous ascorbate.
GlaxoSmithKline Pharmaceuticals LtdAddress AB Road Worli Mumbai7 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2010年10月15日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 7
- 主要终点
- Mean Hemoglobin Rise in each ferrous bisglycinate chelate group (1 tablet daily and 2 tablets daily).
研究概览
简要总结
Study design and patient population: This will be a multicentre, randomized, laboratory-blinded, parallel- group study. It is projected that the study will randomize 270 women (90 subjects in each treatment arm) with iron deficiency anaemia (Hb 8-9gm/dl + serum transferrin saturation <15%) to either Ferronine (ferrous bisglycinate chelate) 1 or 2 tablets/day, or Orofer XT (ferrous ascorbate) 1 tablet/day for 8 weeks. At fortnightly visits, blood will be collected for Hb (to evaluate efficacy), adverse events will be documented (to evaluate tolerability), the investigational drugs will be dispensed and reasons for non compliance will be recorded. Study endpoints: The primary endpoint is defined as the rise of Hb from baseline after 8 weeks of treatment in each ferrous bisglycinate chelate group (1 tablet/day and 2 tablets/day). The secondary endpoints include the difference in the average change in Hb, difference in the rate of rise of Hb, difference in the proportion of patients who achieve a target Hb ≥11gm/dl and difference in the % incidence of gastrointestinal side effects during 8 week therapy with 2 dosing regimens of ferrous bisglycinate chelate (1 tablet/day and 2 tablets/day) and ferrous ascorbate 1 tablet/day. Target of 270 Subject completed on 23/12/2010.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Signed and dated written informed consent is obtained prior to participation.
- •Female outpatients between 18 to 55 years of age and using effective method of contraception if sexually active.
- •Non use of any iron supplement for 3 months prior to enrolment to the study.
- •Presence of iron deficiency anaemia: low haemoglobin (Hb 6-9 gm/dl) + low serum ferritin (15 μg/l).
- •No occult blood in stool.
- •Able to comply with the requirements of the protocol.
- •Subjects should have a valid telephone contact.
排除标准
- •Pregnancy (confirmed by urine dipstick method) Desire to conceive within the next 3 months including patients who are receiving treatment to facilitate conception.
- •Lactating women.
- •Medical history of current hematological disorders other than iron deficiency anaemia (e.g. aplastic anaemia, megaloblastic anaemia, sideroblastic anaemia, pernicious anaemia, thalassemia, sickle cell anaemia, etc.).
- •Medical history of thyroid dysfunction.
- •Medical history of chronic renal disease.
- •Medical history of malabsorption syndrome, haemochromatosis and haemosiderosis, hypochlorhydria, achlorhydria, gastrectomy, gastrojejunostomy.
- •Inability to withhold prohibited medication.
- •Clinically significant abnormality in laboratory reports and/or ECG.
- •Medical history of hepatitis B, hepatitis C and/or exposure to HIV.
- •Serious, uncontrolled disease (other than thyroid dysfunction and chronic renal disease) including serious psychological disorders likely to interfere with the study and/or likely to cause death within the study period.
- •Participation in another clinical trial in the last 8 weeks before entry to Visit
- •Evidence of alcohol or drug abuse, that may, in the opinion of the investigator interfere with study compliance or prevent understanding of the objectives, investigational procedures or possible consequences of the study.
- •Known or suspected hypersensitivity to iron or any of the components of Ferronine or Orofer XT tablets.
结局指标
主要结局
Mean Hemoglobin Rise in each ferrous bisglycinate chelate group (1 tablet daily and 2 tablets daily).
时间窗: every 2 Weeks upto 8 weeks
次要结局
- 1. Haemoglobin at 8 weeks in each ferrous bisglycinate chelate group (ferrous bisglycinate chelate 1 and 2 tablets daily) and in the ferrous ascorbate group (1 tablet daily).2. Haemoglobin at 2 weeks, 4 weeks, 6 weeks and 8 weeks in each ferrous bisglycinate chelate group (ferrous bisglycinate chelate 1 and 2 tablets daily) and in the ferrous ascorbate group (1 tablet daily).3. The proportion of patients who achieve a target Hb ≥11gm/dl at 8 weeks in each ferrous bisglycinate chelate group (ferrous bisglycinate chelate 1 tablet and 2 tablets daily) and in the ferrous ascorbate group (1 tablet daily).(8 Weeks)
- 2.To compare the average rate of rise of haemoglobin during 8 weeks of treatment with ferrous bisglycinate chelate 1 tablet daily, ferrous bisglycinate chelate 2 tablets daily and ferrous ascorbate 1 tablet daily.(8 weeks)
- 3.To compare the proportion of patients who achieve a target Hb ≥ 12gm/dl after 8 weeks of treatment with ferrous bisglycinate chelate 1 tablet daily, ferrous bisglycinate chelate 2 tablets daily and ferrous ascorbate 1 tablet daily.(8 weeks)
- 4.To compare the % incidence of gastrointestinal side effects during 8 weeks treatment with ferrous bisglycinate chelate 1 tablet daily, ferrous bisglycinate chelate 2 tablets daily and ferrous ascorbate 1 tablet daily.(8 weeks)
研究者
研究点 (7)
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