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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
256
Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks). Administered orally with water.
Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks). Administered orally with water.
Administered orally with water.
15
Changsha, China
16
Changsha, China
1
Fuzhou, China
10
Guangzhou, China
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12
Time frame: From Baseline to Week 12
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 2
Time frame: From Baseline to Week 2
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 4
Time frame: From Baseline to Week 4
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 8
Time frame: From Baseline to Week 8
Percentage of Responders at Week 12
Responders are defined as having an increment of Hemoglobin (Hb) \> 15 g/L and post-treatment Hb \> 120 g/L (male) or \> 110 g/L (female) at Visit 6 (Week 12).
Time frame: End of Treatment Period (Week 12)
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Administered orally with water.
5
Hangzhou, China
6
Hangzhou, China
7
Jinan, China
8
Jinan, China
13
Shanxi, China
14
Shanxi, China
...and 5 more locations