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    Clinical Trial Results:
    Pentaerithrityl tetranitrate (PETN) for secondary prevention of intrauterine growth restriction (PETN Trial)

    Summary
    EudraCT number
    		 2016-004396-51
    Trial protocol
    		 DE  
    Global end of trial date
    07 Feb 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jan 2024
    First version publication date
    06 Jan 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ZKS_0021PETN
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03669185
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 German Clinical Trial Register (DRKS): DRKS-ID: DRKS00011374
    Sponsors
    Sponsor organisation name
    Friedrich-Schiller-Universität Jena
    Sponsor organisation address
    Am Klinikum 1, Jena, Germany, 07747
    Public contact
    Project Manager, Jena University Hospital, Center for Clinical Studies, ZKS@med.uni-jena.de
    Scientific contact
    sponsor represented, Jena University Hospital, Department for Obstetrics, Petn@med.uni-jena.de
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Mar 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Feb 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Feb 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This trial investigates the efficacy and safety of PETN to reduce the incidence of intrauterine growth restriction, perinatal death and accompanied preterm delivery in women with insufficient placental development and uterine perfusion identified by pathological uterine artery Doppler at 19+0 to 22+6 weeks of gestation.
    Protection of trial subjects
    The application of the intervention (investigational drug/matching placebo, two tablets per day) is very similar to the one usually applied in clinical routine. Study specific measures were limited to additional laboratory parameter during inclusion procedere and data collection.
    Background therapy
    		 -
    Evidence for comparator
    		 matching placebo used
    Actual start date of recruitment
    30 Jun 2017
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Ethical reason, Scientific research
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 317
    Worldwide total number of subjects
    317
    EEA total number of subjects
    317
    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)
    0
    Adults (18-64 years)
    317
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 317 female pregnant patients were recruited from 15th Aug 2017 to 27th Mar 2021.

    Pre-assignment
    Screening details
    		 A total of 688 patients were presented for study inclusion at the study centers, of which 154 patients did not meet one or more inclusion criteria during the study center examination, 204 patients did not consent to study participation, and 16 patients were excluded for other reasons. A total of 317 patients were included.

    Period 1
    Period 1 title
    treatment period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Verum arm
    Arm description
    		 patients in verum arm took 2 times daily of one tablet each Pentalong® 50 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pentalong® 50mg
    Investigational medicinal product code
    Other name
    PETN
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral intake of one tablet twice daily (total of 100 mg PETN).

    Arm title
    		 placebo arm
    Arm description
    		 Patients in the placebo arm took one tablet each of placebo 2 times daily
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral intake of one tablet twice daily.

    Number of subjects in period 1
    		Verum arm placebo arm
    Started
    155
    162
    Completed
    155
    162
    Period 2
    Period 2 title
    Follow up 12 months
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Verum arm
    Arm description
    		 patients in verum arm took 2 times daily of one tablet each Pentalong® 50 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pentalong® 50mg
    Investigational medicinal product code
    Other name
    PETN
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral intake of one tablet twice daily (total of 100 mg PETN).

    Arm title
    		 placebo arm
    Arm description
    		 Patients in the placebo arm took one tablet each of placebo 2 times daily
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral intake of one tablet twice daily.

    Number of subjects in period 2
    		Verum arm placebo arm
    Started
    155
    162
    Completed
    155
    162

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    treatment period
    Reporting group description
    		 Pregnant women (singleton pregnancy) aged 18 years and older with available pathologic uterine Doppler indices in the uterine arteries (left and right) at 19+0 SSW to 22+6 SSW (mean PI (left and right) must exceed a mean of 1.6 or at least the 95% percentile according to Gomez (Gomez 2008)) who gave written informed consent for study participation were included.

    Reporting group values
    		 treatment period Total
    Number of subjects
    		 317 317
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 34 (18 to 44) -
    Gender categorical
    Units: Subjects
        Female
    		 317 317
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Verum arm
    Reporting group description
    		 patients in verum arm took 2 times daily of one tablet each Pentalong® 50 mg

    Reporting group title
    placebo arm
    Reporting group description
    		 Patients in the placebo arm took one tablet each of placebo 2 times daily
    Reporting group title
    Verum arm
    Reporting group description
    		 patients in verum arm took 2 times daily of one tablet each Pentalong® 50 mg

    Reporting group title
    placebo arm
    Reporting group description
    		 Patients in the placebo arm took one tablet each of placebo 2 times daily

    Primary: combined perinatal death and/or development of FGR

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    End point title
    		 combined perinatal death and/or development of FGR
    End point description
    End point type
    Primary
    End point timeframe
    from randomization to 7 days after birth
    End point values
    		 Verum arm placebo arm
    Number of subjects analysed
    151
    156
    Units: subjects
        yes
    62
    71
        no
    89
    85
    Statistical analysis title
    		 relative risk
    Comparison groups
    Verum arm v placebo arm
    Number of subjects included in analysis
    307
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.43
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 1.17

    Secondary: perinatal death

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    End point title
    		 perinatal death
    End point description
    End point type
    Secondary
    End point timeframe
    from randomization to 7 days after birth
    End point values
    		 Verum arm placebo arm
    Number of subjects analysed
    151
    156
    Units: subjects
        yes
    5
    7
        no
    146
    149
    Statistical analysis title
    		 relative risk
    Comparison groups
    placebo arm v Verum arm
    Number of subjects included in analysis
    307
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.24
         upper limit
    		 2.27

    Secondary: Birthweight below third percentile and/or perinatal death and/or placental abruption

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    End point title
    		 Birthweight below third percentile and/or perinatal death and/or placental abruption
    End point description
    End point type
    Secondary
    End point timeframe
    from randomization to 7 days after birth
    End point values
    		 Verum arm placebo arm
    Number of subjects analysed
    151
    156
    Units: subjects
        yes
    38
    41
        no
    113
    115
    Statistical analysis title
    		 relative risk
    Comparison groups
    Verum arm v placebo arm
    Number of subjects included in analysis
    307
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.82
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 1.41

    Secondary: Birthweight <10th percentile

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    End point title
    		 Birthweight <10th percentile
    End point description
    End point type
    Secondary
    End point timeframe
    at birth
    End point values
    		 Verum arm placebo arm
    Number of subjects analysed
    151
    156
    Units: subjects
        yes
    61
    69
        no
    90
    87
    Statistical analysis title
    		 relative risk
    Comparison groups
    Verum arm v placebo arm
    Number of subjects included in analysis
    307
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.53
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.19

    Secondary: Birthweight <5th percentile

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    End point title
    		 Birthweight <5th percentile
    End point description
    End point type
    Secondary
    End point timeframe
    at birth
    End point values
    		 Verum arm placebo arm
    Number of subjects analysed
    151
    156
    Units: subjects
        yes
    38
    41
        no
    113
    115
    Statistical analysis title
    		 relative risk
    Comparison groups
    Verum arm v placebo arm
    Number of subjects included in analysis
    307
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.85
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 1.41

    Secondary: Birthweight <3rd percentile

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    End point title
    		 Birthweight <3rd percentile
    End point description
    End point type
    Secondary
    End point timeframe
    at birth
    End point values
    		 Verum arm placebo arm
    Number of subjects analysed
    151
    156
    Units: subjects
        yes
    32
    35
        no
    119
    121
    Statistical analysis title
    		 relative risk
    Comparison groups
    Verum arm v placebo arm
    Number of subjects included in analysis
    307
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.81
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 1.46

    Secondary: FGR and birth before 30 weeks

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    End point title
    		 FGR and birth before 30 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    at birthy
    End point values
    		 Verum arm placebo arm
    Number of subjects analysed
    151
    156
    Units: subjects
        yes
    10
    13
        no
    141
    143
    Statistical analysis title
    		 relative risk
    Comparison groups
    Verum arm v placebo arm
    Number of subjects included in analysis
    307
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.58
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.36
         upper limit
    		 1.78

    Secondary: FGR and birth before 34 weeks

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    End point title
    		 FGR and birth before 34 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    at birth
    End point values
    		 Verum arm placebo arm
    Number of subjects analysed
    151
    156
    Units: subjects
        yes
    18
    23
        no
    133
    133
    Statistical analysis title
    		 relative risk
    Comparison groups
    Verum arm v placebo arm
    Number of subjects included in analysis
    307
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.48
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.45
         upper limit
    		 1.45

    Secondary: preterm delivery before 37 weeks

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    End point title
    		 preterm delivery before 37 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    at birth
    End point values
    		 Verum arm placebo arm
    Number of subjects analysed
    151
    156
    Units: subjects
        yes
    57
    81
        no
    94
    75
    Statistical analysis title
    		 relative risk
    Comparison groups
    Verum arm v placebo arm
    Number of subjects included in analysis
    307
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 0.94

    Secondary: preterm delivery before 34 weeks

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    End point title
    		 preterm delivery before 34 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    at birth
    End point values
    		 Verum arm placebo arm
    Number of subjects analysed
    151
    156
    Units: subjects
        yes
    39
    49
        no
    112
    107
    Statistical analysis title
    		 relative risk
    Comparison groups
    Verum arm v placebo arm
    Number of subjects included in analysis
    307
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.28
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 1.18

    Secondary: stay at intensive care unit

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    End point title
    		 stay at intensive care unit
    End point description
    End point type
    Secondary
    End point timeframe
    from birth to admission
    End point values
    		 Verum arm placebo arm
    Number of subjects analysed
    151
    156
    Units: subjects
        yes
    63
    80
        no
    88
    76
    Statistical analysis title
    		 relative risk
    Comparison groups
    Verum arm v placebo arm
    Number of subjects included in analysis
    307
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.07
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.03

    Secondary: Combined neonatal outcome

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    End point title
    		 Combined neonatal outcome
    End point description
    Combined outcome of need of ventilation, occurence of intraventricular hemorrhage III - IV or necrotized enterocolitis requiring surgery
    End point type
    Secondary
    End point timeframe
    birth to admission
    End point values
    		 Verum arm placebo arm
    Number of subjects analysed
    151
    156
    Units: subjects
        yes
    45
    53
        no
    106
    103
    Statistical analysis title
    		 relative risk
    Comparison groups
    Verum arm v placebo arm
    Number of subjects included in analysis
    307
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.37
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 1.2

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From treatment start to 12 months follow-up
    Adverse event reporting additional description
    Adverse adverse were collected for mother, child (unborn) and mother and child together
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Verum arm
    Reporting group description
    		 patients in verum arm took 2 times daily of one tablet each Pentalong® 50 mg

    Reporting group title
    placebo arm
    Reporting group description
    		 Patients in the placebo arm took one tablet each of placebo 2 times daily

    Serious adverse events
    		 Verum arm placebo arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    61 / 155 (39.35%)
    87 / 162 (53.70%)
         number of deaths (all causes)
    5
    9
         number of deaths resulting from adverse events
    Pregnancy, puerperium and perinatal conditions
    HELLP syndrome
    Additional description: Serious adverse events affected both mother and child
         subjects affected / exposed
    7 / 155 (4.52%)
    9 / 162 (5.56%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Placental insufficiency
    Additional description: Serious adverse events affected both mother and child
         subjects affected / exposed
    25 / 155 (16.13%)
    30 / 162 (18.52%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 30
         deaths causally related to treatment / all
    0 / 5
    0 / 6
    Pre-eclampsia
    Additional description: Serious adverse events affected both mother and child
         subjects affected / exposed
    14 / 155 (9.03%)
    23 / 162 (14.20%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Premature labour
         subjects affected / exposed
    10 / 155 (6.45%)
    20 / 162 (12.35%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Verum arm placebo arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    63 / 155 (40.65%)
    88 / 162 (54.32%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    15 / 155 (9.68%)
    16 / 162 (9.88%)
         occurrences all number
    17
    25
    Headache
         subjects affected / exposed
    43 / 155 (27.74%)
    41 / 162 (25.31%)
         occurrences all number
    107
    63
    Pregnancy, puerperium and perinatal conditions
    Gestational hypertension
         subjects affected / exposed
    2 / 155 (1.29%)
    12 / 162 (7.41%)
         occurrences all number
    2
    12
    HELLP syndrome
         subjects affected / exposed
    7 / 155 (4.52%)
    9 / 162 (5.56%)
         occurrences all number
    7
    9
    Placental insufficiency
         subjects affected / exposed
    25 / 155 (16.13%)
    31 / 162 (19.14%)
         occurrences all number
    26
    31
    Pre-eclampsia
         subjects affected / exposed
    14 / 155 (9.03%)
    23 / 162 (14.20%)
         occurrences all number
    14
    23
    Premature labour
         subjects affected / exposed
    11 / 155 (7.10%)
    20 / 162 (12.35%)
         occurrences all number
    11
    20
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    13 / 155 (8.39%)
    13 / 162 (8.02%)
         occurrences all number
    28
    20
    Diarrhoea
         subjects affected / exposed
    11 / 155 (7.10%)
    8 / 162 (4.94%)
         occurrences all number
    21
    11
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    25 / 155 (16.13%)
    19 / 162 (11.73%)
         occurrences all number
    28
    25

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Dec 2018
    Extension of recruitment period Specifying the termination criteria Concretization of the statistical methods
    09 Dec 2019
    Extension of recruitment period
    15 Mar 2021
    Correction of secundary outcome (Writing error)

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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