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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004380-20 | EudraCT Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Polyferose | Active Comparator | Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12 | From Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 15 | Changsha | China | ||||
| 16 |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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Participant Flow refers to the Randomized Set (RS). The RS includes all subjects who have a randomization number recorded on the Case Report Form (CRF).
This multicenter study started to enroll subjects in March 2011 in order to end up with 16 centers in China with enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. Placebo to Polyferose: Administered orally with water. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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. |
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| Placebo to Ferrous (II) Glycine Sulphate Complex | Other | Administered orally with water. |
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| Placebo to Polyferose | Other | Administered orally with water. |
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| Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 8 |
| From Baseline 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). | End of Treatment Period (Week 12) |
| Changsha |
| China |
| 1 | Fuzhou | China |
| 10 | Guangzhou | China |
| 5 | Hangzhou | China |
| 6 | Hangzhou | China |
| 7 | Jinan | China |
| 8 | Jinan | China |
| 13 | Shanxi | China |
| 14 | Shanxi | China |
| 12 | Shenyang | China |
| 2 | Tianjin | China |
| 17 | Wenzhou | China |
| 4 | Wuxi | China |
| 9 | Xi'an | China |
| FG001 | Polyferose | Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex. 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. Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water. |
| Safety Set |
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| Full Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
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Baseline Characteristics refer to the Full Analysis Set (FAS). FAS consists of all enrolled subjects who took at least one dose of study medicine and have at least one post-baseline effectiveness measurement (Hemoglobin-value). It also includes subjects with protocol deviance and incomplete data due to withdrawal.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. Placebo to Polyferose: Administered orally with water. |
| BG001 | Polyferose | Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex. 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. Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Weight | Mean | Standard Deviation | kilogram (kg) |
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| Height | Mean | Standard Deviation | centimeter (cm) |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12 | The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects' validity concerning the efficacy analysis. | Posted | Mean | Standard Deviation | gramm per liter (g/L) | From Baseline to Week 12 |
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| Secondary | Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 2 | The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects' validity concerning the efficacy analysis. | Posted | Mean | Standard Deviation | gramm per liter (g/L) | From Baseline to Week 2 |
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| Secondary | Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 4 | The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects' validity concerning the efficacy analysis. | Posted | Mean | Standard Deviation | gramm per liter (g/L) | From Baseline to Week 4 |
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| Secondary | Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 8 | The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects' validity concerning the efficacy analysis. | Posted | Mean | Standard Deviation | gramm per liter (g/L) | From Baseline to Week 8 |
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| Secondary | 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). | The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects' validity concerning the efficacy analysis. | Posted | Number | percentage of participants | End of Treatment Period (Week 12) |
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Adverse Events were collected up to 14 weeks from Baseline to the Safety Follow-Up Visit.
Adverse Events refer to the Safety Set (SS). SS represents all subjects included in the study who took at least one dose of study medication and have at least one safety evaluation after that.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. Placebo to Polyferose: Administered orally with water. | 3 | 126 | 22 | 126 | ||
| EG001 | Polyferose | Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex. 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. Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water. | 3 | 122 | 25 | 122 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion induced | Surgical and medical procedures | MedDRA 16.0 | Non-systematic Assessment |
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| Measles | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
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| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
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| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Melaena | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB | +1 877 822 9493 (UCB) |
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C030676 | ferroglycine sulfate |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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