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

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ClinicalTrials.gov Identifier: NCT01425463
Recruitment Status : Completed
First Posted : August 30, 2011
Results First Posted : November 6, 2014
Last Update Posted : June 1, 2015
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( Sanol GmbH )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Iron Deficiency Anemia
Interventions Drug: Ferrous (II) Glycine Sulphate Complex
Drug: Polyferose
Other: Placebo to Ferrous (II) Glycine Sulphate Complex
Other: Placebo to Polyferose
Enrollment 256
Recruitment Details This multicenter study started to enroll subjects in March 2011 in order to end up with 16 centers in China with enrolled subjects.
Pre-assignment Details 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).
Arm/Group Title Ferrous (II) Glycine Sulphate Complex Polyferose
Hide Arm/Group 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.

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 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.

Period Title: Overall Study
Started 130 126
Safety Set 126 122
Full Analysis Set 122 116
Completed 106 102
Not Completed 24 24
Reason Not Completed
Adverse Event             5             7
Lack of Efficacy             1             1
Protocol Violation             2             2
Lost to Follow-up             5             2
Withdrawal by Subject             7             5
Unknown Reason             4             7
Arm/Group Title Ferrous (II) Glycine Sulphate Complex Polyferose Total
Hide Arm/Group 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.

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 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 of all reporting groups
Overall Number of Baseline Participants 122 116 238
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 122 participants 116 participants 238 participants
37.2  (8.5) 37.8  (7.9) 37.5  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 122 participants 116 participants 238 participants
Female
122
 100.0%
115
  99.1%
237
  99.6%
Male
0
   0.0%
1
   0.9%
1
   0.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 122 participants 116 participants 238 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
122
 100.0%
116
 100.0%
238
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 122 participants 116 participants 238 participants
122 116 238
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 122 participants 116 participants 238 participants
58.2  (7.8) 58.1  (7.6) 58.1  (7.7)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 122 participants 116 participants 238 participants
161.2  (4.4) 161.2  (4.6) 161.2  (4.5)
1.Primary Outcome
Title Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12
Hide Description [Not Specified]
Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ferrous (II) Glycine Sulphate Complex Polyferose
Hide Arm/Group 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.

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 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 Number of Participants Analyzed 95 92
Mean (Standard Deviation)
Unit of Measure: gramm per liter (g/L)
31.47  (23.77) 31.92  (21.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ferrous (II) Glycine Sulphate Complex, Polyferose
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority of the investigational drug (Ferrous (II) Glycine Sulphate Complex) to the reference drug (Polyferose) was concluded if the lower limit of the two-sided 95 % confidence interval was greater than -7.0 g/L.
Method of Estimation Estimation Parameter LS-Mean of ANCOVA
Estimated Value -2.19
Confidence Interval (2-Sided) 95%
-8.47 to 4.09
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 2
Hide Description [Not Specified]
Time Frame From Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ferrous (II) Glycine Sulphate Complex Polyferose
Hide Arm/Group 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.

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 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 Number of Participants Analyzed 93 91
Mean (Standard Deviation)
Unit of Measure: gramm per liter (g/L)
12.29  (13.60) 12.79  (13.13)
3.Secondary Outcome
Title Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 4
Hide Description [Not Specified]
Time Frame From Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ferrous (II) Glycine Sulphate Complex Polyferose
Hide Arm/Group 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.

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 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 Number of Participants Analyzed 95 92
Mean (Standard Deviation)
Unit of Measure: gramm per liter (g/L)
20.37  (19.63) 20.16  (17.46)
4.Secondary Outcome
Title Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 8
Hide Description [Not Specified]
Time Frame From Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ferrous (II) Glycine Sulphate Complex Polyferose
Hide Arm/Group 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.

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 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 Number of Participants Analyzed 95 92
Mean (Standard Deviation)
Unit of Measure: gramm per liter (g/L)
26.57  (22.67) 28.33  (20.90)
5.Secondary Outcome
Title Percentage of Responders at Week 12
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ferrous (II) Glycine Sulphate Complex Polyferose
Hide Arm/Group 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.

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 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 Number of Participants Analyzed 95 92
Measure Type: Number
Unit of Measure: percentage of participants
71.6 80.4
Time Frame Adverse Events were collected up to 14 weeks from Baseline to the Safety Follow-Up Visit.
Adverse Event Reporting Description 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.
 
Arm/Group Title Ferrous (II) Glycine Sulphate Complex Polyferose
Hide Arm/Group 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.

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 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.

All-Cause Mortality
Ferrous (II) Glycine Sulphate Complex Polyferose
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ferrous (II) Glycine Sulphate Complex Polyferose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/126 (2.38%)      3/122 (2.46%)    
Infections and infestations     
Measles * 1  1/126 (0.79%)  1 0/122 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine leiomyoma * 1  0/126 (0.00%)  0 1/122 (0.82%)  1
Nervous system disorders     
Subarachnoid haemorrhage * 1  0/126 (0.00%)  0 1/122 (0.82%)  1
Surgical and medical procedures     
Abortion induced * 1  2/126 (1.59%)  2 1/122 (0.82%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ferrous (II) Glycine Sulphate Complex Polyferose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/126 (17.46%)      25/122 (20.49%)    
Gastrointestinal disorders     
Diarrhoea * 1  9/126 (7.14%)  10 11/122 (9.02%)  14
Abdominal pain * 1  7/126 (5.56%)  9 5/122 (4.10%)  6
Melaena * 1  6/126 (4.76%)  6 8/122 (6.56%)  9
Nausea * 1  3/126 (2.38%)  3 7/122 (5.74%)  7
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
Phone: +1 877 822 9493 (UCB)
Layout table for additonal information
Responsible Party: UCB Pharma ( Sanol GmbH )
ClinicalTrials.gov Identifier: NCT01425463     History of Changes
Other Study ID Numbers: SP0986
2014-004380-20 ( EudraCT Number )
First Submitted: August 26, 2011
First Posted: August 30, 2011
Results First Submitted: October 30, 2014
Results First Posted: November 6, 2014
Last Update Posted: June 1, 2015