NCT01425463

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2011

Typical duration for phase_3

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 30, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
1 year until next milestone

Results Posted

Study results publicly available

November 6, 2014

Completed
Last Updated

June 1, 2015

Status Verified

May 1, 2015

Enrollment Period

2.6 years

First QC Date

August 26, 2011

Results QC Date

October 30, 2014

Last Update Submit

May 8, 2015

Conditions

Iron Deficiency Anemia

Keywords

Ferrous (II) Glycine Sulphate ComplexPolyferoseFerro Sanol duodenalNiferexIron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

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

    From Baseline to Week 12

Secondary Outcomes (4)

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

    From Baseline to Week 2

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

    From Baseline to Week 4

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

    From Baseline to Week 8

  • Percentage of Responders at Week 12

    End of Treatment Period (Week 12)

Study Arms (2)

Ferrous (II) Glycine Sulphate Complex

EXPERIMENTAL

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 ComplexOther: Placebo to Polyferose

Polyferose

ACTIVE COMPARATOR

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

Drug: PolyferoseOther: Placebo to Ferrous (II) Glycine Sulphate Complex

Interventions

Ferrous (II) Glycine Sulphate ComplexDRUG

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.

Also known as: Ferro Sanol Duodenal
Ferrous (II) Glycine Sulphate Complex
PolyferoseDRUG

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.

Also known as: Nifirex
Polyferose
Placebo to Ferrous (II) Glycine Sulphate ComplexOTHER

Administered orally with water.

Polyferose
Placebo to PolyferoseOTHER

Administered orally with water.

Ferrous (II) Glycine Sulphate Complex

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • With any Mal-absorption Syndrome
  • With a history of Thalassemia or Sickle Cell Anemia
  • With untreated concurrent Vitamin B12 or Folate deficiency at Baseline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

15

Changsha, China

Location

16

Changsha, China

Location

1

Fuzhou, China

Location

10

Guangzhou, China

Location

5

Hangzhou, China

Location

6

Hangzhou, China

Location

7

Jinan, China

Location

8

Jinan, China

Location

13

Shanxi, China

Location

14

Shanxi, China

Location

12

Shenyang, China

Location

2

Tianjin, China

Location

17

Wenzhou, China

Location

4

Wuxi, China

Location

9

Xi'an, China

Location

Related Links

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferroglycine sulfate

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
UCB Clinical Trial Call Center
Organization
UCB
+1 877 822 9493 (UCB)

Study Officials

  • UCB Clinical Trial Call Center

    +1 877 822 9493 (UCB)

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2011

First Posted

August 30, 2011

Study Start

March 1, 2011

Primary Completion

October 1, 2013

Study Completion

November 1, 2013

Last Updated

June 1, 2015

Results First Posted

November 6, 2014

Record last verified: 2015-05

Locations

CN(15)