A Double-blind, Double-dummy, Parallel, Active-controlled, Randomized Trial to Evaluate Efficacy & Safety in Anemia Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Iron Deficiency Anemia

Intervention / Treatment
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* Drug: Ferrous (II) Glycine Sulphate Complex
* Drug: Polyferose
* Other: Placebo to Ferrous (II) Glycine Sulphate Complex
* Other: Placebo to Polyferose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: With any Mal-absorption Syndrome With a history of Thalassemia or Sickle Cell Anemia With untreated concurrent Vitamin B12 or Folate deficiency at Baseline

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ferrous (II) Glycine Sulphate Complex<br>Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose. | Drug: Ferrous (II) Glycine Sulphate Complex<br>* 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.<br>* Other names: Ferro Sanol Duodenal;Other: Placebo to Polyferose<br>* Administered orally with water.<br>|
| Active Comparator: Polyferose<br>Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex. | Drug: Polyferose<br>* 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.<br>* Other names: Nifirex;Other: Placebo to Ferrous (II) Glycine Sulphate Complex<br>* Administered orally with water.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12 |  | From Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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). | End of Treatment Period (Week 12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ferrous (II) Glycine Sulphate Complex, Polyferose, Ferro Sanol duodenal, Niferex, Iron Deficiency Anemia