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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2014-004380-20
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    14 Nov 2013

    Results information
    Results version number
    		 v1
    This version publication date
    08 Jul 2016
    First version publication date
    24 May 2015
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    SP0986
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01425463
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanol GmbH
    Sponsor organisation address
    Alfred-Nobel-Str. 10, Monheim, Germany, 40789
    Public contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, 0049 2173 48 1515, clinicaltrials@ucb.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, 0049 2173 48 1515, clinicaltrials@ucb.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Mar 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Nov 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary study objective was to show non-inferiority of efficacy of Ferro Sanol Duodenal as test drug compared to Niferex as reference product after 12 weeks therapy in subjects with manifest iron deficiency anemia.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Comparison against other approved standard therapy for iron supplementation in Iron Deficiency Anemia (IDA).
    Actual start date of recruitment
    29 Mar 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    China: 256
    Worldwide total number of subjects
    256
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    1
    Adults (18-64 years)
    254
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    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
    Screening 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).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ferrous (II) Glycine Sulphate Complex
    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. 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ferro Sanol® Duodenal
    Investigational medicinal product code
    Other name
    Ferrous (II) Glycine Sulfate Complex
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    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.

    Arm title
    		 Polyferose
    Arm description
    		 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.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Niferex
    Investigational medicinal product code
    Other name
    Polysaccharide Iron Complex
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    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.

    Number of subjects in period 1
    		Ferrous (II) Glycine Sulphate Complex Polyferose
    Started
    130
    126
    Safety Set
    126
    122
    Full Analysis Set
    122
    116
    Safety Set
    126
    122
    Full Analysis Set
    122
    116
    Completed
    106
    102
    Not completed
    24
    24
         Consent withdrawn by subject
    7
    5
         Unknown Reason
    4
    7
         Non-Fatal, Serious AE(s)
    1
    2
         Lost to follow-up
    5
    2
         Non-Fatal, Non-Serious AE(s)
    4
    5
         Lack of efficacy
    1
    1
         Protocol deviation
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ferrous (II) Glycine Sulphate Complex
    Reporting 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.

    Reporting group title
    Polyferose
    Reporting group description
    		 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.

    Reporting group values
    		 Ferrous (II) Glycine Sulphate Complex Polyferose Total
    Number of subjects
    		 130 126 256
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 0 1 1
        Adults (18-64 years)
    		 129 125 254
        From 65-84 years
    		 1 0 1
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.6 ( 8.7 ) 37.5 ( 7.9 ) -
    Gender categorical
    Units: Subjects
        Male
    		 0 1 1
        Female
    		 130 125 255
    Weight
    Units: kilogram (kg)
        arithmetic mean (standard deviation)
    		 58.3 ( 7.6 ) 58.1 ( 7.5 ) -
    Height
    Units: centimeter (cm)
        arithmetic mean (standard deviation)
    		 161.2 ( 4.3 ) 161.2 ( 4.5 ) -

    End points

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    End points reporting groups
    Reporting group title
    Ferrous (II) Glycine Sulphate Complex
    Reporting 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.

    Reporting group title
    Polyferose
    Reporting group description
    		 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.

    Subject analysis set title
    PPS (Ferrous treated subjects)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per-Protocol Set (PPS) is defined as a subset of the Full Analysis Set, excluding all subjects with protocol deviations considered important for the subjects' validity concerning the efficacy analysis.

    Subject analysis set title
    PPS (Polyferose treated subjects)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per-Protocol Set (PPS) is defined as a subset of the Full Analysis Set, excluding all subjects with protocol deviations considered important for the subjects' validity concerning the efficacy analysis.

    Primary: Change in Hemoglobin (Hb) from Baseline (Week 0) to Week 12

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    End point title
    		 Change in Hemoglobin (Hb) from Baseline (Week 0) to Week 12
    End point description
    End point type
    Primary
    End point timeframe
    From Baseline to Week 12
    End point values
    		 PPS (Ferrous treated subjects) PPS (Polyferose treated subjects)
    Number of subjects analysed
    95
    92
    Units: gramm per liter (g/L)
        arithmetic mean (standard deviation)
    31.47 ( 23.77 )
    31.92 ( 21.82 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    PPS (Ferrous treated subjects) v PPS (Polyferose treated subjects)
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 LS-Mean of ANCOVA
    Point estimate
    -2.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.47
         upper limit
    		 4.09
    Notes
    [1] - 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.

    Secondary: Change in Hemoglobin (Hb) from Baseline (Week 0) to Week 2

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    End point title
    		 Change in Hemoglobin (Hb) from Baseline (Week 0) to Week 2
    End point description
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 2
    End point values
    		 PPS (Ferrous treated subjects) PPS (Polyferose treated subjects)
    Number of subjects analysed
    93
    91
    Units: gramm per liter (g/L)
        arithmetic mean (standard deviation)
    12.29 ( 13.6 )
    12.79 ( 13.13 )
    No statistical analyses for this end point

    Secondary: Change in Hemoglobin (Hb) from Baseline (Week 0) to Week 4

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    End point title
    		 Change in Hemoglobin (Hb) from Baseline (Week 0) to Week 4
    End point description
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 4
    End point values
    		 PPS (Ferrous treated subjects) PPS (Polyferose treated subjects)
    Number of subjects analysed
    95
    92
    Units: gramm per liter (g/L)
        arithmetic mean (standard deviation)
    20.37 ( 19.63 )
    20.16 ( 17.46 )
    No statistical analyses for this end point

    Secondary: Change in Hemoglobin (Hb) from Baseline (Week 0) to Week 8

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    End point title
    		 Change in Hemoglobin (Hb) from Baseline (Week 0) to Week 8
    End point description
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 8
    End point values
    		 PPS (Ferrous treated subjects) PPS (Polyferose treated subjects)
    Number of subjects analysed
    95
    92
    Units: gramm per liter (g/L)
        arithmetic mean (standard deviation)
    26.57 ( 22.67 )
    28.33 ( 20.9 )
    No statistical analyses for this end point

    Secondary: Percentage of Responders at Week 12

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    End point title
    		 Percentage of Responders at Week 12
    End point 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).
    End point type
    Secondary
    End point timeframe
    End of Treatment Period (Week 12)
    End point values
    		 PPS (Ferrous treated subjects) PPS (Polyferose treated subjects)
    Number of subjects analysed
    95
    92
    Units: percentage of participants
        number (not applicable)
    71.6
    80.4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events were collected up to 14 weeks from Baseline to the Safety Follow-Up Visit.
    Adverse event reporting additional 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.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Polyferose
    Reporting group description
    		 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.

    Reporting group title
    Ferrous (II) Glycine Sulphate Complex
    Reporting 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.

    Serious adverse events
    		 Polyferose Ferrous (II) Glycine Sulphate Complex
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 122 (2.46%)
    3 / 126 (2.38%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    1 / 122 (0.82%)
    2 / 126 (1.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Measles
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Polyferose Ferrous (II) Glycine Sulphate Complex
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 122 (20.49%)
    22 / 126 (17.46%)
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    11 / 122 (9.02%)
    9 / 126 (7.14%)
         occurrences all number
    14
    10
    Abdominal pain
         subjects affected / exposed
    5 / 122 (4.10%)
    7 / 126 (5.56%)
         occurrences all number
    6
    9
    Melaena
         subjects affected / exposed
    8 / 122 (6.56%)
    6 / 126 (4.76%)
         occurrences all number
    9
    6
    Nausea
         subjects affected / exposed
    7 / 122 (5.74%)
    3 / 126 (2.38%)
         occurrences all number
    7
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    07 Jun 2011
    Investigational medicinal product (IMP) recall, due to stability failure which lead to physical unblinding.
    04 Jun 2012

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Not applicable
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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