A Double-blind, Double-dummy, Parallel, Active-controlled, Randomized and Multi-center Trial to Investigate Efficacy and Safety in Subjects With Iron Deficiency Anemia for Ferrous (II) Glycine Sulphate Complex Versus Polyferose Capsules Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 256
- 试验地点
- 15
- 主要终点
- Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12
研究概览
简要总结
To evaluate the efficacy and safety of 12 weeks treatment with Ferrous (II) Glycine Sulphate Complex in comparison to Polyferose capsules in Chinese subjects with manifest Iron Deficiency Anemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An iron deficiency anemia patient with Serum Ferritin < 12 ng/mL, serum Hb-values >60 and < 120 g/L in males, < 110 g/L in females
排除标准
- •With any Mal-absorption Syndrome
- •With a history of Thalassemia or Sickle Cell Anemia
- •With untreated concurrent Vitamin B12 or Folate deficiency at Baseline
研究组 & 干预措施
Polyferose
Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.
干预措施: Placebo to Ferrous (II) Glycine Sulphate Complex (Other)
Polyferose
Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.
干预措施: Polyferose (Drug)
Ferrous (II) Glycine Sulphate Complex
Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.
干预措施: Ferrous (II) Glycine Sulphate Complex (Drug)
Ferrous (II) Glycine Sulphate Complex
Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.
干预措施: Placebo to Polyferose (Other)
结局指标
主要结局
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12
时间窗: From Baseline to Week 12
次要结局
- Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 2(From Baseline to Week 2)
- Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 4(From Baseline to Week 4)
- Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 8(From Baseline to Week 8)
- Percentage of Responders at Week 12(End of Treatment Period (Week 12))