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

May 8, 2015 updated by: Sanol GmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

256

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

Other Names:
  • Ferro Sanol Duodenal
Other: Placebo to Polyferose
Administered orally with water.
Active Comparator: Polyferose
Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.
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 Names:
  • Nifirex
Other: Placebo to Ferrous (II) Glycine Sulphate Complex
Administered orally with water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12
Time Frame: From Baseline to Week 12
From Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 2
Time Frame: From Baseline to Week 2
From Baseline to Week 2
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 4
Time Frame: From Baseline to Week 4
From Baseline to Week 4
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 8
Time Frame: From Baseline to Week 8
From Baseline to Week 8
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).
End of Treatment Period (Week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanol GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

August 26, 2011

First Submitted That Met QC Criteria

August 26, 2011

First Posted (Estimate)

August 30, 2011

Study Record Updates

Last Update Posted (Estimate)

June 1, 2015

Last Update Submitted That Met QC Criteria

May 8, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP0986
  • 2014-004380-20 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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