NCT01425463

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Sanol GmbH · Industry
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Iron Deficiency Anemia

Interventions

Type	Name	Description
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.
DRUG	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.
OTHER	Placebo to Polyferose	Administered orally with water.

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-10-01
• Completion: 2013-11-01
• First posted: 2011-08-30
• Last updated: 2015-06-01
• Results posted: 2014-11-06

Locations

15 sites across 1 country: China