Trial Outcomes & Findings for A Double-blind, Double-dummy, Parallel, Active-controlled, Randomized Trial to Evaluate Efficacy & Safety in Anemia Subjects (NCT NCT01425463)
NCT ID: NCT01425463
Last Updated: 2015-06-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
256 participants
Primary outcome timeframe
From Baseline to Week 12
Results posted on
2015-06-01
Participant Flow
This multicenter study started to enroll subjects in March 2011 in order to end up with 16 centers in China with enrolled subjects.
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).
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
130
|
126
|
|
Overall Study
Safety Set
|
126
|
122
|
|
Overall Study
Full Analysis Set
|
122
|
116
|
|
Overall Study
COMPLETED
|
106
|
102
|
|
Overall Study
NOT COMPLETED
|
24
|
24
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
7
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Protocol Violation
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
2
|
|
Overall Study
Withdrawal by Subject
|
7
|
5
|
|
Overall Study
Unknown Reason
|
4
|
7
|
Baseline Characteristics
A Double-blind, Double-dummy, Parallel, Active-controlled, Randomized Trial to Evaluate Efficacy & Safety in Anemia Subjects
Baseline characteristics by cohort
| Measure |
Ferrous (II) Glycine Sulphate Complex
n=122 Participants
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.
|
Polyferose
n=116 Participants
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.
|
Total
n=238 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.2 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
37.8 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
37.5 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
237 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
122 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
122 participants
n=5 Participants
|
116 participants
n=7 Participants
|
238 participants
n=5 Participants
|
|
Weight
|
58.2 kilogram (kg)
STANDARD_DEVIATION 7.8 • n=5 Participants
|
58.1 kilogram (kg)
STANDARD_DEVIATION 7.6 • n=7 Participants
|
58.1 kilogram (kg)
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Height
|
161.2 centimeter (cm)
STANDARD_DEVIATION 4.4 • n=5 Participants
|
161.2 centimeter (cm)
STANDARD_DEVIATION 4.6 • n=7 Participants
|
161.2 centimeter (cm)
STANDARD_DEVIATION 4.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 12Population: 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.
Outcome measures
| Measure |
Ferrous (II) Glycine Sulphate Complex
n=95 Participants
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.
|
Polyferose
n=92 Participants
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.
|
|---|---|---|
|
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12
|
31.47 gramm per liter (g/L)
Standard Deviation 23.77
|
31.92 gramm per liter (g/L)
Standard Deviation 21.82
|
SECONDARY outcome
Timeframe: From Baseline to Week 2Population: 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.
Outcome measures
| Measure |
Ferrous (II) Glycine Sulphate Complex
n=93 Participants
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.
|
Polyferose
n=91 Participants
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.
|
|---|---|---|
|
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 2
|
12.29 gramm per liter (g/L)
Standard Deviation 13.60
|
12.79 gramm per liter (g/L)
Standard Deviation 13.13
|
SECONDARY outcome
Timeframe: From Baseline to Week 4Population: 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.
Outcome measures
| Measure |
Ferrous (II) Glycine Sulphate Complex
n=95 Participants
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.
|
Polyferose
n=92 Participants
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.
|
|---|---|---|
|
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 4
|
20.37 gramm per liter (g/L)
Standard Deviation 19.63
|
20.16 gramm per liter (g/L)
Standard Deviation 17.46
|
SECONDARY outcome
Timeframe: From Baseline to Week 8Population: 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.
Outcome measures
| Measure |
Ferrous (II) Glycine Sulphate Complex
n=95 Participants
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.
|
Polyferose
n=92 Participants
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.
|
|---|---|---|
|
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 8
|
26.57 gramm per liter (g/L)
Standard Deviation 22.67
|
28.33 gramm per liter (g/L)
Standard Deviation 20.90
|
SECONDARY outcome
Timeframe: End of Treatment Period (Week 12)Population: 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.
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).
Outcome measures
| Measure |
Ferrous (II) Glycine Sulphate Complex
n=95 Participants
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.
|
Polyferose
n=92 Participants
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.
|
|---|---|---|
|
Percentage of Responders at Week 12
|
71.6 percentage of participants
|
80.4 percentage of participants
|
Adverse Events
Ferrous (II) Glycine Sulphate Complex
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Polyferose
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ferrous (II) Glycine Sulphate Complex
n=126 participants at risk
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.
|
Polyferose
n=122 participants at risk
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.
|
|---|---|---|
|
Surgical and medical procedures
Abortion induced
|
1.6%
2/126 • Number of events 2 • 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.
|
0.82%
1/122 • Number of events 1 • 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.
|
|
Infections and infestations
Measles
|
0.79%
1/126 • Number of events 1 • 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.
|
0.00%
0/122 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/126 • 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.
|
0.82%
1/122 • Number of events 1 • 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.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/126 • 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.
|
0.82%
1/122 • Number of events 1 • 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.
|
Other adverse events
| Measure |
Ferrous (II) Glycine Sulphate Complex
n=126 participants at risk
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.
|
Polyferose
n=122 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
9/126 • Number of events 10 • 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.
|
9.0%
11/122 • Number of events 14 • 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.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
7/126 • Number of events 9 • 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.
|
4.1%
5/122 • Number of events 6 • 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.
|
|
Gastrointestinal disorders
Melaena
|
4.8%
6/126 • Number of events 6 • 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.
|
6.6%
8/122 • Number of events 9 • 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.
|
|
Gastrointestinal disorders
Nausea
|
2.4%
3/126 • Number of events 3 • 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.
|
5.7%
7/122 • Number of events 7 • 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.
|
Additional Information
UCB Clinical Trial Call Center
UCB
Phone: +1 877 822 9493 (UCB)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60