search
Back to results

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

Primary Purpose

Iron Deficiency Anemia

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Ferrous (II) Glycine Sulphate Complex
Polyferose
Placebo to Ferrous (II) Glycine Sulphate Complex
Placebo to Polyferose
Sponsored by
Sanol GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia focused on measuring Ferrous (II) Glycine Sulphate Complex, Polyferose, Ferro Sanol duodenal, Niferex, Iron Deficiency Anemia

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • 15
  • 16
  • 1
  • 10
  • 5
  • 6
  • 7
  • 8
  • 13
  • 14
  • 12
  • 2
  • 17
  • 4
  • 9

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ferrous (II) Glycine Sulphate Complex

Polyferose

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 2
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 4
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 8
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).

Full Information

First Posted
August 26, 2011
Last Updated
May 8, 2015
Sponsor
Sanol GmbH
search

1. Study Identification

Unique Protocol Identification Number
NCT01425463
Brief Title
A Double-blind, Double-dummy, Parallel, Active-controlled, Randomized Trial to Evaluate Efficacy & Safety in Anemia Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanol GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia
Keywords
Ferrous (II) Glycine Sulphate Complex, Polyferose, Ferro Sanol duodenal, Niferex, Iron Deficiency Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
256 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ferrous (II) Glycine Sulphate Complex
Arm Type
Experimental
Arm 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.
Arm Title
Polyferose
Arm Type
Active Comparator
Arm Description
Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.
Intervention Type
Drug
Intervention Name(s)
Ferrous (II) Glycine Sulphate Complex
Other Intervention Name(s)
Ferro Sanol Duodenal
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Polyferose
Other Intervention Name(s)
Nifirex
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo to Ferrous (II) Glycine Sulphate Complex
Intervention Description
Administered orally with water.
Intervention Type
Other
Intervention Name(s)
Placebo to Polyferose
Intervention Description
Administered orally with water.
Primary Outcome Measure Information:
Title
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12
Time Frame
From Baseline to Week 12
Secondary Outcome Measure Information:
Title
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 2
Time Frame
From Baseline to Week 2
Title
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 4
Time Frame
From Baseline to Week 4
Title
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 8
Time Frame
From Baseline to Week 8
Title
Percentage of Responders at Week 12
Description
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).
Time Frame
End of Treatment Period (Week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
15
City
Changsha
Country
China
Facility Name
16
City
Changsha
Country
China
Facility Name
1
City
Fuzhou
Country
China
Facility Name
10
City
Guangzhou
Country
China
Facility Name
5
City
Hangzhou
Country
China
Facility Name
6
City
Hangzhou
Country
China
Facility Name
7
City
Jinan
Country
China
Facility Name
8
City
Jinan
Country
China
Facility Name
13
City
Shanxi
Country
China
Facility Name
14
City
Shanxi
Country
China
Facility Name
12
City
Shenyang
Country
China
Facility Name
2
City
Tianjin
Country
China
Facility Name
17
City
Wenzhou
Country
China
Facility Name
4
City
Wuxi
Country
China
Facility Name
9
City
Xi'an
Country
China

12. IPD Sharing Statement

Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

We'll reach out to this number within 24 hrs