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

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01425463
• Other study ID #: SP0986
• Secondary ID: 2014-004380-20
• Status: Completed
• Phase: Phase 3
• First received: August 26, 2011
• Last updated: May 8, 2015
• Start date: March 2011
• Est. completion date: November 2013

Study information

• Verified date: May 2015
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia

Intervention

Drug:
• Ferrous (II) Glycine Sulphate Complex
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.
• Polyferose
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.

Other:
• Placebo to Ferrous (II) Glycine Sulphate Complex
Administered orally with water.
• Placebo to Polyferose
Administered orally with water.

Locations

Country	Name	City	State
China	15	Changsha
China	16	Changsha
China	1	Fuzhou
China	10	Guangzhou
China	5	Hangzhou
China	6	Hangzhou
China	7	Jinan
China	8	Jinan
China	13	Shanxi
China	14	Shanxi
China	12	Shenyang
China	2	Tianjin
China	17	Wenzhou
China	4	Wuxi
China	9	Xi'an

Sponsors (1)

Lead Sponsor	Collaborator
Sanol GmbH

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12		From Baseline to Week 12	No
Secondary	Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 2		From Baseline to Week 2	No
Secondary	Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 4		From Baseline to Week 4	No
Secondary	Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 8		From Baseline to Week 8	No
Secondary	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)	No

External Links

•   FDA Safety Alerts and Recalls