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

Phase 3

Completed

• Conditions: Iron Deficiency Anemia
• Interventions: Drug: Ferrous (II) Glycine Sulphate Complex; Drug: Polyferose; Other: Placebo to Polyferose; Other: Placebo to Ferrous (II) Glycine Sulphate Complex

• Registration Number: NCT01425463
• Lead Sponsor: Sanol GmbH

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-08-26
• Study First Submitted QC: 2011-08-26
• Study First Posted: 2011-08-30
• Primary Completion: 2013-10
• Study Completion: 2013-11
• Results First Submitted: 2014-10-30
• Results First Submitted QC: 2014-10-30
• Results First Posted: 2014-11-06
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-08
• Last Update Posted: 2015-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ferrous (II) Glycine Sulphate Complex	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.
Ferrous (II) Glycine Sulphate Complex	Placebo to Polyferose	Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.
Polyferose	Placebo to Ferrous (II) Glycine Sulphate Complex	Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.
Polyferose	Polyferose	Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12	From Baseline to Week 12

Secondary Outcome Measures

Name	Time	Method
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)	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).

Trial Locations

Locations (15)

5; 🇨🇳 Hangzhou, China

6; 🇨🇳 Hangzhou, China

10; 🇨🇳 Guangzhou, China

7; 🇨🇳 Jinan, China

14; 🇨🇳 Shanxi, China

17; 🇨🇳 Wenzhou, China

4; 🇨🇳 Wuxi, China

9; 🇨🇳 Xi'an, China

13; 🇨🇳 Shanxi, China

1; 🇨🇳 Fuzhou, China

15; 🇨🇳 Changsha, China

16; 🇨🇳 Changsha, China

8; 🇨🇳 Jinan, China

12; 🇨🇳 Shenyang, China

2; 🇨🇳 Tianjin, China