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Completed

NCT Number: NCT01425463

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

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.

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Key information

Conditions

Iron Deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

15, Changsha, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferrous (II) Glycine Sulphate Complex

Drug

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.

Other names: Ferro Sanol Duodenal

Polyferose

Drug

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 names: Nifirex

Placebo to Ferrous (II) Glycine Sulphate Complex

Other

Administered orally with water.

Placebo to Polyferose

Other

Administered orally with water.

Primary outcomes

  1. Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12

    Time frame: From Baseline to Week 12

Secondary outcomes

  1. Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 2

    Time frame: From Baseline to Week 2

  2. Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 4

    Time frame: From Baseline to Week 4

  3. Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 8

    Time frame: From Baseline to Week 8

  4. Percentage of Responders at Week 12

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Sanol GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 30, 2011
Registry last updated
Jun 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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