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    Clinical Trial Results:
    Pilot study with St. Gero for heartburn

    Summary
    EudraCT number
    		 2013-001584-22
    Trial protocol
    		 DE  
    Global end of trial date
    28 Aug 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 May 2020
    First version publication date
    22 May 2020
    Other versions
    Summary report(s)
    		 2013-001584-22_Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    VDM/032711
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gerolsteiner Brunnen GmbH & Co. KG
    Sponsor organisation address
    Vulkanring, Gerolstein, Germany,
    Public contact
    Leiter Techn. Entw. u. Ressourcen, Gerolsteiner Brunnen GmbH & Co. KG, 0049 659114423, drthomas.hens@gerolsteiner.com
    Scientific contact
    Leiter Techn. Entw. u. Ressourcen, Gerolsteiner Brunnen GmbH & Co. KG, 0049 659114423, drthomas.hens@gerolsteiner.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Jun 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Aug 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Investigation of the efficacy and tolerability of St. Gero in the pre / post comparison. Efficacy parameters: -Therapeutic course based on the questionnaire data (questionnaires "Reflux Disease Questionnaire" (RDQ) / "Quality of Life in Reflux and Dyspepsia" (QOLRAD) / "Gastrointestinal Quality of Life Index" (GLQI)) -Difference in the frequency of heartburn episodes per week -Difference in the subjective perception of well-being (SF-12 questionnaire ) -Global assessment of efficacy by patient and investigator Tolerability parameters: -Adverse events (AEs) -Difference in blood pressure/heart rate -Differences in safety laboratory parameters -Global assessment of tolerability by patient and investigator
    Protection of trial subjects
    The investigators ensured that the subjects were given full and adequate oral and written information (subject information) about the nature, purpose, consequences and possible risk of the clinical study. The subjects were given the opportunity to ask questions and were allowed sufficient time to consider the information provided. Subjects provided informed consent before the conduct of any study specific procedure. The collected data were made available to the CRO and the study’s sponsor only in pseudonymous form, to minimize the chances of matching the data to an individual person.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 2013
    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
    Germany: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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)
    50
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period: July 2013 - April 2014 Subjects were recruited in Berlin, Germany.

    Pre-assignment
    Screening details
    		 56 Patients were screened; 6 patients were excluded from further participation mainly due to violations of in-/exclusion criteria and non-compliance in the run-in period.

    Period 1
    Period 1 title
    Intervention (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Intervention
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    St. Gero
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    1,5 l of St. Gero per day: 3 times a day 300 ml before or with a meal; the remaining volume should be consumed over the day.

    Number of subjects in period 1
    		Intervention
    Started
    50
    Completed
    49
    Not completed
    1
         Consent withdrawn by subject
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 -

    Reporting group values
    		 Intervention Total
    Number of subjects
    		 50 50
    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
        arithmetic mean (standard deviation)
    		 40.9 ( 11.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 22 22
        Male
    		 28 28

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 -

    Primary: Difference in the frequency of heartburn episodes per week

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    End point title
    		 Difference in the frequency of heartburn episodes per week [1]
    End point description
    End point type
    Primary
    End point timeframe
    Pre / post comparison (V5-V2)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    48
    Units: Heartburn/week
        arithmetic mean (standard deviation)
    -5.06 ( 4.81 )
    No statistical analyses for this end point

    Primary: Global assessment of efficacy by patient

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    End point title
    		 Global assessment of efficacy by patient [2]
    End point description
    End point type
    Primary
    End point timeframe
    post intervention
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    47
    Units: Number of patients
        Very good
    18
        Good
    24
        Moderate
    4
        Poor
    1
    No statistical analyses for this end point

    Primary: Global assessment of tolerability by patient

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    End point title
    		 Global assessment of tolerability by patient [3]
    End point description
    End point type
    Primary
    End point timeframe
    Post intervention
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    47
    Units: Number of patients
        Very good
    41
        Good
    4
        Moderate
    2
        Poor
    0
    No statistical analyses for this end point

    Primary: Global assessment of tolerability by investigator

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    End point title
    		 Global assessment of tolerability by investigator [4]
    End point description
    End point type
    Primary
    End point timeframe
    post intervention
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    47
    Units: Number of cases
        Very good
    42
        Good
    3
        Moderate
    2
        Poor
    0
    No statistical analyses for this end point

    Primary: Global assessment of efficacy by investigator

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    End point title
    		 Global assessment of efficacy by investigator [5]
    End point description
    End point type
    Primary
    End point timeframe
    Post intervention
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    47
    Units: Number of cases
        Very good
    18
        Good
    25
        Moderate
    3
        Poor
    1
    No statistical analyses for this end point

    Primary: "Reflux Disease Questionnaire" (RDQ)- heartburn

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    End point title
    		 "Reflux Disease Questionnaire" (RDQ)- heartburn [6]
    End point description
    End point type
    Primary
    End point timeframe
    Pre / post comparison (V2-V5)
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    47
    Units: Score
    arithmetic mean (standard deviation)
        Frequency
    1.66 ( 1.86 )
        Intensity
    1.91 ( 2.03 )
    No statistical analyses for this end point

    Primary: "Reflux Disease Questionnaire" (RDQ)- regurgitation

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    End point title
    		 "Reflux Disease Questionnaire" (RDQ)- regurgitation [7]
    End point description
    End point type
    Primary
    End point timeframe
    pre / post comparison (V2-V5)
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    46
    Units: Score
    arithmetic mean (standard deviation)
        Frequency
    2.48 ( 2.31 )
        Intensity
    2.54 ( 2.79 )
    No statistical analyses for this end point

    Primary: "Reflux Disease Questionnaire" (RDQ)- GERD

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    End point title
    		 "Reflux Disease Questionnaire" (RDQ)- GERD [8]
    End point description
    End point type
    Primary
    End point timeframe
    pre / post comparison (V2-V5)
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    46
    Units: Score
    arithmetic mean (standard deviation)
        Frequency
    4.17 ( 3.27 )
        Intensity
    4.50 ( 4.09 )
    No statistical analyses for this end point

    Primary: "Reflux Disease Questionnaire" (RDQ)- dyspepsia

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    End point title
    		 "Reflux Disease Questionnaire" (RDQ)- dyspepsia [9]
    End point description
    End point type
    Primary
    End point timeframe
    pre / post comparison (V2-V5)
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    45
    Units: Score
    arithmetic mean (standard deviation)
        Frequency
    1.73 ( 2.17 )
        Intensity
    1.80 ( 2.40 )
    No statistical analyses for this end point

    Primary: "Quality of Life in Reflux and Dyspepsia" (QOLRAD)

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    End point title
    		 "Quality of Life in Reflux and Dyspepsia" (QOLRAD) [10]
    End point description
    End point type
    Primary
    End point timeframe
    Pre / post comparison (V5-V2)
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    48
    Units: Mean score
    arithmetic mean (standard deviation)
        Emotional distress
    0.84 ( 1.05 )
        Sleep disturbances
    0.71 ( 1.03 )
        Food/drink problems
    1.10 ( 1.20 )
        Physical/social functioning
    0.63 ( 0.84 )
        Vitality
    0.83 ( 1.12 )
    No statistical analyses for this end point

    Primary: "Gastrointestinal Quality of Life Index" (GLQI)

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    End point title
    		 "Gastrointestinal Quality of Life Index" (GLQI) [11]
    End point description
    End point type
    Primary
    End point timeframe
    pre / post comparison (V5-V2)
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    48
    Units: Score
    arithmetic mean (standard deviation)
        Total
    16.6 ( 16.2 )
        Symptoms
    10.8 ( 9.4 )
        Emotions
    2.2 ( 3.1 )
        Physical function
    2.6 ( 4.9 )
        Social function
    1.0 ( 2.2 )
    No statistical analyses for this end point

    Primary: Difference in the subjective perception of well-being (SF-12 questionnaire )

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    End point title
    		 Difference in the subjective perception of well-being (SF-12 questionnaire ) [12]
    End point description
    End point type
    Primary
    End point timeframe
    pre / post comparison (V5-V2)
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    48
    Units: Score points
    arithmetic mean (standard deviation)
        General health
    -0.44 ( 0.71 )
        Moderate activities
    0.06 ( 0.32 )
        Climbing several flights of stairs
    0.02 ( 0.33 )
        Accomplished less due to physical health
    0.11 ( 0.43 )
        Limitations in the kind of work
    0.09 ( 0.28 )
        Accomplished less to to emotional problems
    0.04 ( 0.46 )
        Carefulness
    0.02 ( 0.44 )
        Pain interfering normal work
    -0.46 ( 0.65 )
        Felt calm and peaceful
    -0.60 ( 1.27 )
        A lot of energy
    -0.54 ( 1.18 )
        Downhearted and blue
    0.44 ( 1.25 )
        Social activities
    0.19 ( 0.76 )
    No statistical analyses for this end point

    Primary: Difference in blood pressure

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    End point title
    		 Difference in blood pressure [13]
    End point description
    End point type
    Primary
    End point timeframe
    pre / post comparison (V5-V2)
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    48
    Units: mmHg
    arithmetic mean (standard deviation)
        Systolic
    -3.54 ( 8.87 )
        Diastolic
    -3.02 ( 6.50 )
    No statistical analyses for this end point

    Primary: Difference in heart rate

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    End point title
    		 Difference in heart rate [14]
    End point description
    End point type
    Primary
    End point timeframe
    pre / post comparison (V5-V2)
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    48
    Units: 1/min
        arithmetic mean (standard deviation)
    -2.21 ( 5.87 )
    No statistical analyses for this end point

    Primary: Difference in safety laboratory parameters-Hemoglobin

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    End point title
    		 Difference in safety laboratory parameters-Hemoglobin [15]
    End point description
    End point type
    Primary
    End point timeframe
    pre / post comparison (V5-V1)
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    47
    Units: mmol/l
        arithmetic mean (standard deviation)
    0.04 ( 0.45 )
    No statistical analyses for this end point

    Primary: Difference in safety laboratory parameters- hematocrit

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    End point title
    		 Difference in safety laboratory parameters- hematocrit [16]
    End point description
    End point type
    Primary
    End point timeframe
    pre / post comparison (V5-V1)
    Notes
    [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    47
    Units: l/l
        arithmetic mean (standard deviation)
    0.001 ( 0.022 )
    No statistical analyses for this end point

    Primary: Difference in safety laboratory parameters - Erythrocytes

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    End point title
    		 Difference in safety laboratory parameters - Erythrocytes [17]
    End point description
    End point type
    Primary
    End point timeframe
    pre / post comparison (V5-V1)
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    47
    Units: Tpt/l
        arithmetic mean (standard deviation)
    0.01 ( 0.23 )
    No statistical analyses for this end point

    Primary: Difference in safety laboratory parameters -Thrombocytes

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    End point title
    		 Difference in safety laboratory parameters -Thrombocytes [18]
    End point description
    End point type
    Primary
    End point timeframe
    pre / post comparison (V5-V1)
    Notes
    [18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    47
    Units: Gpt/l
        arithmetic mean (standard deviation)
    -0.49 ( 24.58 )
    No statistical analyses for this end point

    Primary: Difference in safety laboratory parameters - Leucocytes

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    End point title
    		 Difference in safety laboratory parameters - Leucocytes [19]
    End point description
    End point type
    Primary
    End point timeframe
    pre / post comparison (V5-V1)
    Notes
    [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    47
    Units: Gpt/l
        arithmetic mean (standard deviation)
    -0.01 ( 1.20 )
    No statistical analyses for this end point

    Primary: Difference in safety laboratory parameters - ALAT

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    End point title
    		 Difference in safety laboratory parameters - ALAT [20]
    End point description
    End point type
    Primary
    End point timeframe
    pre / post comparison (V5-V1)
    Notes
    [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    47
    Units: µkat/l
        arithmetic mean (standard deviation)
    0.004 ( 0.125 )
    No statistical analyses for this end point

    Primary: Difference in safety laboratory parameters - ASAT

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    End point title
    		 Difference in safety laboratory parameters - ASAT [21]
    End point description
    End point type
    Primary
    End point timeframe
    pre / post comparison (V5-V1)
    Notes
    [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    47
    Units: µkat/l
        arithmetic mean (standard deviation)
    0.003 ( 0.133 )
    No statistical analyses for this end point

    Primary: Difference in safety laboratory parameters - gGT

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    End point title
    		 Difference in safety laboratory parameters - gGT [22]
    End point description
    End point type
    Primary
    End point timeframe
    pre /post comparison (V5-V1)
    Notes
    [22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    47
    Units: µkat/l
        arithmetic mean (standard deviation)
    -0.032 ( 0.170 )
    No statistical analyses for this end point

    Primary: Difference in safety laboratory parameters - AP

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    End point title
    		 Difference in safety laboratory parameters - AP [23]
    End point description
    End point type
    Primary
    End point timeframe
    pre / post comparison (V5-V1)
    Notes
    [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    47
    Units: µkat/l
        arithmetic mean (standard deviation)
    -0.021 ( 0.145 )
    No statistical analyses for this end point

    Primary: Difference in safety laboratory parameters - Bilirubin

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    End point title
    		 Difference in safety laboratory parameters - Bilirubin [24]
    End point description
    End point type
    Primary
    End point timeframe
    pre / post comparison (V5-V1)
    Notes
    [24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    47
    Units: µmol/l
        arithmetic mean (standard deviation)
    1.16 ( 4.65 )
    No statistical analyses for this end point

    Primary: Difference in safety laboratory parameters - Creatinine

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    End point title
    		 Difference in safety laboratory parameters - Creatinine [25]
    End point description
    End point type
    Primary
    End point timeframe
    pre /post comparison (V5-V1)
    Notes
    [25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    47
    Units: µmol/l
        arithmetic mean (standard deviation)
    0.98 ( 6.85 )
    No statistical analyses for this end point

    Primary: Difference in safety laboratory parameters - Urea

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    End point title
    		 Difference in safety laboratory parameters - Urea [26]
    End point description
    End point type
    Primary
    End point timeframe
    (V5-V1)
    Notes
    [26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    47
    Units: mmol/l
        arithmetic mean (standard deviation)
    0.21 ( 1.10 )
    No statistical analyses for this end point

    Primary: Difference in safety laboratory parameters - Uric acid

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    End point title
    		 Difference in safety laboratory parameters - Uric acid [27]
    End point description
    End point type
    Primary
    End point timeframe
    V5-V1
    Notes
    [27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a pilot study with only one intervention arm, thus pre/post comparisons were performed in the statistical analysis. However, it is not possible to specify this using the available entry options, as an error warning comes up stating the at least two groups need to be compared.
    End point values
    		 Intervention
    Number of subjects analysed
    47
    Units: µmol/l
        arithmetic mean (standard deviation)
    3.38 ( 40.52 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    V1-V5
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 -

    Serious adverse events
    		 Intervention
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 49 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Intervention
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 49 (4.08%)
    General disorders and administration site conditions
    Headache
         subjects affected / exposed
    2 / 49 (4.08%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Nov 2013
    Change of investigator and project manager. Increase of maximal age for study participation from 55 years to 64 years.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26909240
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