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

Sanol

Status and phase: Completed; Phase 3

Conditions: Iron Deficiency Anemia

Treatments: Other: Placebo to Polyferose; Other: Placebo to Ferrous (II) Glycine Sulphate Complex; Drug: Polyferose; Drug: Ferrous (II) Glycine Sulphate Complex

Study type: Interventional

Funder types: Industry

Identifiers

NCT01425463

2014-004380-20 (EudraCT Number)

SP0986

Details and patient eligibility

About

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.

Enrollment: 256 patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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256 participants in 2 patient groups

Ferrous (II) Glycine Sulphate Complex

Experimental group

Description:

Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.

Treatment:

Other: Placebo to Polyferose

Drug: Ferrous (II) Glycine Sulphate Complex

Polyferose

Active Comparator group

Description:

Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.

Treatment:

Other: Placebo to Ferrous (II) Glycine Sulphate Complex

Drug: Polyferose