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    Clinical Trial Results:
    NEUPRO OL, Efficacy profile of Neurexan® in an experimental acute stress setting – an explorative open-label study in healthy probands

    Summary
    EudraCT number
    		 2012-002359-40
    Trial protocol
    		 DE  
    Global end of trial date
    04 Apr 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Oct 2017
    First version publication date
    28 Oct 2017
    Other versions
    Summary report(s)
    		 C1202 NEUPRO Open label study (Neurexan)

    Trial information

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    Trial identification
    Sponsor protocol code
    C1202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01703832
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Biologische Heilmittel Heel GmbH
    Sponsor organisation address
    Dr.-Reckeweg-Str. 2-4, Baden-Baden, Germany, 76532
    Public contact
    Biologische Heilmittel Heel GmbH, Biologische Heilmittel Heel GmbH, +49 7221-501-0, info@heel.com
    Scientific contact
    Biologische Heilmittel Heel GmbH, Biologische Heilmittel Heel GmbH, +49 7221-501-0, info@heel.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
    04 Apr 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Apr 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Apr 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is the efficacy of Neurexan® on tension and nervousness perception using visual analogue scales (VAS) when study participants undergo an emotional stressful condition as compared to natural course. The test method for this study is the TSST protocol.
    Protection of trial subjects
    Routine monitoring was performed to verify that rights and well being of participants were protected.
    Background therapy
    		 8 subjects took contraceptives (5 in the Neurexan Group, 3 in the Placebo Group)
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Oct 2012
    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: 65
    Worldwide total number of subjects
    65
    EEA total number of subjects
    65
    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)
    65
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was carried out in 2 outpatient clinics in Germany (Marburg and Essen).

    Pre-assignment
    Screening details
    		 Telephone pre-screening was carried out and individuals received gross Information about the study. If they were suited for study participation an appointment for the medical and psychological screening was made. Interested volunteers were invited to the study site for the 1st visit and received oral and written Information about study and ICF.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Neurexan group
    Arm description
    		 33 participants were randomized to Neurexan. One premature terminator could not be evaluated for primary efficacy, so 32 participants in the Neurexan group formed the full analysis Set for analysis of efficacy. All randomised subjects were included in the analysis of safety.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Neurexan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One Neurexan tablet contains: 0.6 mg Avena sativa (dil. D2), 0.6 mg Coffea arabica (dil. D12), 0.6 mg Passiflora incarnata (dil. D2), 0.6 mg Zincum isovalerianum (dil. D4), lactose monohydrate and magnesium stearate Route of administration: oral Total administered: 6 tablets (over a period of 2.5 hours - one tablet every 30 minutes)

    Arm title
    		 Natoural course group
    Arm description
    		 All of the 32 participants randomised to the Natural Course group formed the full analysis set for analysis of efficacy and safety.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Neurexan group Natoural course group
    Started
    33
    32
    Completed
    32
    32
    Not completed
    1
    0
         Consent withdrawn by subject
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Neurexan group
    Reporting group description
    		 33 participants were randomized to Neurexan. One premature terminator could not be evaluated for primary efficacy, so 32 participants in the Neurexan group formed the full analysis Set for analysis of efficacy. All randomised subjects were included in the analysis of safety.

    Reporting group title
    Natoural course group
    Reporting group description
    		 All of the 32 participants randomised to the Natural Course group formed the full analysis set for analysis of efficacy and safety.

    Reporting group values
    		 Neurexan group Natoural course group Total
    Number of subjects
    		 33 32 65
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 33 32 65
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.6 ( 8.4 ) 41.3 ( 8.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 17 17 34
        Male
    		 16 15 31
    Ethnic origin
    Units: Subjects
        white
    		 33 32 65
    Body Mass Index (BMI)
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 24.47 ( 2.76 ) 23.11 ( 2.83 ) -
    Trier Inventory for Chronic Stress - screening scale of chronic stress (SSCS)
    Includes scores from five scales (chronic worrying, work and social overload, excessive demands and lack of acceptance).
    Units: score points
        median (full range (min-max))
    		 8 (0 to 19) 9.5 (1 to 23) -
    Global Severity Index (GSI) of psychological distress
    derived from Symptom Checklist 90
    Units: score points
        median (full range (min-max))
    		 0.133 (0 to 0.82) 0.189 (0 to 1.21) -
    Screening height
    Units: cm
        arithmetic mean (standard deviation)
    		 175 ( 9.7 ) 177.2 ( 10.7 ) -
    Screening weight
    Units: kg
        arithmetic mean (standard deviation)
    		 75.35 ( 12.89 ) 73.04 ( 13.81 ) -

    End points

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    End points reporting groups
    Reporting group title
    Neurexan group
    Reporting group description
    		 33 participants were randomized to Neurexan. One premature terminator could not be evaluated for primary efficacy, so 32 participants in the Neurexan group formed the full analysis Set for analysis of efficacy. All randomised subjects were included in the analysis of safety.

    Reporting group title
    Natoural course group
    Reporting group description
    		 All of the 32 participants randomised to the Natural Course group formed the full analysis set for analysis of efficacy and safety.

    Subject analysis set title
    Essen Neurexan group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The secondary endpoint "Change in natural killer (NK) cells" was analysed in the Essen subgroup only.

    Subject analysis set title
    Essen Natoural course group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The secondary endpoint "Change in natural killer (NK) cells" was analysed in the Essen subgroup only.

    Primary: Tension

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    End point title
    		 Tension
    End point description
    Tension was self-assessed by the participants on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS), ranging from 0="not at all" to 100="higly", before and after a stress test. The measurements started 30 min before intake of Neurexan or natural course and were repeated until 100 minutes after the end of the stress test. The total stress was then summarized with the Area under the curve (AUC) method. AUC of VAS Tension value was measured from -210 min to +100 min.
    End point type
    Primary
    End point timeframe
    30 min before first intake of Neurexan or natural course until 100 minutes after end of the stress test, i.e.: -210 min, -180 min, -150 min, -120 min, -90 min, -60 min, -30 min, -15 min, 0 min, +15 min, +30 min, +45 min, +60 min, +75 min, +100 min
    End point values
    		 Neurexan group Natoural course group
    Number of subjects analysed
    32
    32
    Units: mm*min
        median (full range (min-max))
    3089.4 (40 to 20940)
    3253.4 (308 to 19305)
    Statistical analysis title
    		 Descriptive statistics
    Statistical analysis description
    Standard descriptive statistics were calculated for continuous variables. All analyses were performed using Version 9.1.3 or later of SAS Software.
    Comparison groups
    Neurexan group v Natoural course group
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.1233
    Method
    		 ANCOVA
    Parameter type
    		 LS-Mean Difference
    Point estimate
    752.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -210.6
         upper limit
    		 1715.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    481.2

    Primary: Nervousness

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    End point title
    		 Nervousness
    End point description
    Nervousness was self-assessed by the participants on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS), ranging from 0="not at all" to 100="higly", before and after a stress test. The measurements started 30 min before first intake of Neurexan or natoural course and were repeated until 100 minutes after the end of the stress test. The total stress was then summarized with the Area under the curve (AUC) method. AUC of VAS Nervousness value was measured from -210 min to +100 min.
    End point type
    Primary
    End point timeframe
    30 min before first intake of Neurexan or natoural course until 100 minutes after end of the stress test, i.e.: -210 min, -180 min, -150 min, -120 min, -90 min, -60 min, -30 min, -15 min, 0 min, +15 min, +30 min, +45 min, +60 min, +75 min, +100 min
    End point values
    		 Neurexan group Natoural course group
    Number of subjects analysed
    32
    32
    Units: mm*min
        median (full range (min-max))
    2377.3 (12 to 9071)
    3426.8 (329 to 14898)
    Statistical analysis title
    		 Descriptive statistics
    Statistical analysis description
    Standard descriptive statistics were calculated for continuous variables. All analyses were performed using Version 9.1.3 or later of SAS Software.
    Comparison groups
    Neurexan group v Natoural course group
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.5153
    Method
    		 ANCOVA
    Parameter type
    		 LS-Mean Difference
    Point estimate
    334.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -687.6
         upper limit
    		 1356.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    510.7

    Secondary: Alpha amylase

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    End point title
    		 Alpha amylase
    End point description
    The stress biomarker salivary alpha amylase was measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.
    End point type
    Secondary
    End point timeframe
    60 minutes before until 100 minutes after stress test, i.e.: -60 min, +15 min, +45 min, +100 min
    End point values
    		 Neurexan group Natoural course group
    Number of subjects analysed
    32 [1]
    32
    Units: IU/ml
    median (full range (min-max))
        -60 min
    155.6 (21.6 to 594.86)
    133.2 (11.5 to 591.83)
        +15 min
    242.8 (28.19 to 620.26)
    204.9 (9.82 to 819.87)
        +45 min
    171.3 (21.04 to 786.54)
    138.6 (9.61 to 812.83)
        +100 min
    195.8 (17.35 to 597.39)
    144 (8.02 to 509.27)
    Notes
    [1] - Parameter was measured in only 31participants at timepoint -60 min.
    No statistical analyses for this end point

    Secondary: Saliva cortisol

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    End point title
    		 Saliva cortisol
    End point description
    The stress biomarker saliva cortisol was measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.
    End point type
    Secondary
    End point timeframe
    60 minutes before until 100 minutes after stress test, i.e.: -60 min, +15 min, +45 min, +100 min
    End point values
    		 Neurexan group Natoural course group
    Number of subjects analysed
    32 [2]
    32
    Units: nmol/l
    median (full range (min-max))
        -60 min
    7.9 (1.58 to 27.64)
    8.1 (2.84 to 26.39)
        +15 min
    20.3 (2.46 to 121.11)
    19.8 (3.37 to 112.89)
        +45 min
    18.8 (1.22 to 65.42)
    20.6 (2.59 to 33.61)
        +100 min
    8.6 (1.77 to 24.89)
    9.4 (3.44 to 89.56)
    Notes
    [2] - Parameter was measured in only 31participants at timepoint -60 min.
    No statistical analyses for this end point

    Secondary: Adrenocorticotropic Hormone (ACTH)

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    End point title
    		 Adrenocorticotropic Hormone (ACTH)
    End point description
    The stress biomarker Adrenocorticotropic Hormone was measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.
    End point type
    Secondary
    End point timeframe
    60 minutes before until 100 minutes after stress test, i.e.: -60 min, +15 min, +45 min, +100 min
    End point values
    		 Neurexan group Natoural course group
    Number of subjects analysed
    31 [3]
    24
    Units: ng/l
    median (full range (min-max))
        -60 min
    20.8 (6.07 to 283.81)
    20 (7.95 to 112.99)
        +15 min
    35.4 (13.38 to 116.92)
    31 (11.36 to 158.12)
        +45 min
    20.4 (9.05 to 55.69)
    20.6 (7.51 to 84.08)
        +100 min
    11.8 (6.99 to 32.99)
    13.7 (3.3 to 31.58)
    Notes
    [3] - Parameter was measured in only 30 participants at timepoint -60 min
    No statistical analyses for this end point

    Secondary: Epinephrine

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    End point title
    		 Epinephrine
    End point description
    The stress biomarker epinephrine (adrenaline) measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.
    End point type
    Secondary
    End point timeframe
    60 minutes before until 100 minutes after stress test, i.e.: -60 min, +15 min, +45 min, +100 min
    End point values
    		 Neurexan group Natoural course group
    Number of subjects analysed
    30
    23
    Units: ng/l
    median (full range (min-max))
        -60 min
    44.6 (10 to 108)
    37 (11 to 98.6)
        +15 min
    35.4 (10 to 146)
    31 (10 to 88.4)
        +45 min
    37.3 (10 to 105)
    32 (9.1 to 95.5)
        +100 min
    29.8 (0 to 87.7)
    33 (10 to 104)
    No statistical analyses for this end point

    Secondary: Norepinephrine

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    End point title
    		 Norepinephrine
    End point description
    The stress biomarker norepinephrine was measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.
    End point type
    Secondary
    End point timeframe
    60 minutes before until 100 minutes after stress test, i.e.: -60 min, +15 min, +45 min, +100 min
    End point values
    		 Neurexan group Natoural course group
    Number of subjects analysed
    30
    23
    Units: ng/l
    median (full range (min-max))
        -60 min
    484.5 (249 to 923)
    457 (195 to 797)
        +15 min
    575.5 (299 to 1128)
    529 (279 to 1688)
        +45 min
    458 (220 to 889)
    459 (223 to 858)
        +100 min
    467 (269 to 938)
    372 (189 to 839)
    No statistical analyses for this end point

    Secondary: Plasma cortisol

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    End point title
    		 Plasma cortisol
    End point description
    The stress biomarker plasma cortisol was measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.
    End point type
    Secondary
    End point timeframe
    60 minutes before until 100 minutes after stress test, i.e.: -60 min, +15 min, +45 min, +100 min
    End point values
    		 Neurexan group Natoural course group
    Number of subjects analysed
    32
    24
    Units: nmol/l
    median (full range (min-max))
        -60 min
    365.9 (105.11 to 917.95)
    337.6 (125.51 to 836.49)
        +15 min
    554.3 (72.19 to 971.2)
    544.3 (124.52 to 942.52)
        +45 min
    466.8 (73.66 to 842.18)
    506.8 (121.6 to 815.16)
        +100 min
    285.1 (83.99 to 735.4)
    285.1 (136.69 to 637.67)
    No statistical analyses for this end point

    Secondary: Change in Natural killer cells

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    End point title
    		 Change in Natural killer cells
    End point description
    The Natural Killer (NK) Cells as immune cells and stress biomarkers were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.
    End point type
    Secondary
    End point timeframe
    60 minutes before until 100 minutes after stress test, i.e.: -60 min, +15 min, +45 min, +100 min
    End point values
    		 Essen Neurexan group Essen Natoural course group
    Number of subjects analysed
    15
    12
    Units: % of lymphocytes
    median (full range (min-max))
        -60 min
    11.8 (5.8 to 22.6)
    11.2 (5.6 to 16.5)
        +15 min
    21.3 (9.8 to 28.1)
    17.7 (10.1 to 26.2)
        +45 min
    11.6 (4.6 to 14.8)
    8.6 (4.3 to 12.7)
        +100 min
    11.1 (6.1 to 18.2)
    7.8 (4 to 20.3)
    No statistical analyses for this end point

    Secondary: Systolic blood presssure

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    End point title
    		 Systolic blood presssure
    End point description
    Systolic blood pressure was measured before and after a stress test by continuous cardiovascular recording. The measurements started 30 minutes before stress test and were repeated until 45 minutes after the end of the stress test.
    End point type
    Secondary
    End point timeframe
    30 minutes before until 45 minutes after stress test, i.e.: -15 min, 0 min, +15 min, +45 min
    End point values
    		 Neurexan group Natoural course group
    Number of subjects analysed
    32
    32
    Units: mmHg
    median (full range (min-max))
        -15 min
    120.5 (86 to 175)
    123.5 (95 to 147)
        0 min
    131 (98 to 204)
    136.5 (96 to 171)
        +15 min
    123 (92 to 161)
    128.5 (86 to 165)
        +45 min
    121 (77 to 180)
    122 (91 to 160)
    No statistical analyses for this end point

    Secondary: Diastolic blood pressure

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    End point title
    		 Diastolic blood pressure
    End point description
    Diastoblic blood pressure was measured before and after a stress test by continuous cardiovascular recording. The measurements started 30 minutes before stress test and were repeated until 45 minutes after the end of the stress test.
    End point type
    Secondary
    End point timeframe
    30 minutes before until 45 minutes after stress test, i.e.: -15 min, 0 min, +15 min, +45 min
    End point values
    		 Neurexan group Natoural course group
    Number of subjects analysed
    32
    32
    Units: mmHg
    median (full range (min-max))
        -15 min
    78 (51 to 120)
    79 (56 to 103)
        0 min
    83.5 (59 to 138)
    88.5 (60 to 114)
        +15 min
    81.5 (54 to 115)
    83 (54 to 109)
        +45 min
    78 (40 to 124)
    81 (41 to 109)
    No statistical analyses for this end point

    Secondary: Heart rate

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    End point title
    		 Heart rate
    End point description
    Heart rate was measured before and after a stress test by continuous cardiovascular recording. The measurements started 30 minutes before stress test and were repeated until 45 minutes after the end of the stress test.
    End point type
    Secondary
    End point timeframe
    30 minutes before until 45 minutes after stress test, i.e.: -15 min, 0 min, +15 min, +45 min
    End point values
    		 Neurexan group Natoural course group
    Number of subjects analysed
    32
    32
    Units: beats per minute
    median (full range (min-max))
        -15 min
    67 (55 to 96)
    69 (49 to 98)
        0 min
    87 (67 to 135)
    83 (56 to 125)
        +15 min
    68 (54 to 90)
    71 (44 to 93)
        +45 min
    68 (56 to 96)
    72 (48 to 92)
    No statistical analyses for this end point

    Secondary: Modified somatic SCL90

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    End point title
    		 Modified somatic SCL90
    End point description
    The SCL90 has 90 items and covers dimensions like depression, somatization, obsessive-compulsive disorder, social insecurity, anxiety, phobic anxiety, aggression/hostility, paranoid ideation, psychoticism. A new instrument covering potential somatic stress consequences was used in this study, the modified somatic SCL90 that uses the SCL90 somatization items, but instead of a 7 day timeframe asking for "now" (current state). The corresponding items from SCL90 were: 1, 4, 12, 27, 40, 42, 48, 49, 52, 53, 56, 58 and the introductory question had to be: “How much do you currently suffer from...” ("Wie sehr leiden Sie momentan unter:").
    End point type
    Secondary
    End point timeframe
    210 minutes before and 100 minutes after stress test, i.e: -210 min, +100 min
    End point values
    		 Neurexan group Natoural course group
    Number of subjects analysed
    32
    32
    Units: score points
    median (full range (min-max))
        -210 min
    0.042 (0 to 0.67)
    0.083 (0 to 1.08)
        +100 min
    0 (0 to 0.5)
    0 (0 to 0.33)
    No statistical analyses for this end point

    Secondary: State anxiety and stress perception measured by State-Trait

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    End point title
    		 State anxiety and stress perception measured by State-Trait
    End point description
    State anxiety and stress perception were measured by State-Trait Anxiety Inventory X1 before and after a stress test. The measurements took place 90 minutes before stress test and were repeated 15 and 100 minutes after the end of the stress test.
    End point type
    Secondary
    End point timeframe
    90 minutes before stress test and 15 and 100 minutes after the end of the stress test, i.e.: -90 min, +15 min, +100 min
    End point values
    		 Neurexan group Natoural course group
    Number of subjects analysed
    32
    32
    Units: score points
    median (full range (min-max))
        -90 min
    32 (21 to 49)
    33 (22 to 43)
        +15 min
    51 (33 to 73)
    56 (29 to 78)
        +100 min
    32 (21 to 43)
    32 (20 to 52)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Randomization until individual study end, i.e.: i.e.: -180 min, -150 min, -120 min, -90 min, -60 min, -30min, -15 min, 0 min, +15 min, +30 min, +45 min, +60 min, +75 min, +100 min
    Adverse event reporting additional description
    All adverse events that occurred after the participant has received at least one dose of the product under investigation (or same timepoint without intake for natural course) were to be collected and reported
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Neurexan group
    Reporting group description
    		 33 participants were randomized to Neurexan. One premature terminator could not be evaluated for primary efficacy, so 32 participants in the Neurexan group formed the full analysis Set for analysis of efficacy. All randomised subjects were included in the analysis of safety.

    Reporting group title
    Natoural course group
    Reporting group description
    		 All of the 32 participants randomised to the Natural Course group formed the full analysis set for analysis of efficacy and safety.

    Serious adverse events
    		 Neurexan group Natoural course group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Neurexan group Natoural course group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 33 (12.12%)
    3 / 32 (9.38%)
    Investigations
    Alanin aminotransferase increased
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 32 (3.13%)
         occurrences all number
    1
    1
    Procedural dizziness
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Procedural nausea
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Dry mouth
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0

    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? 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/17615391
    http://www.ncbi.nlm.nih.gov/pubmed/16952284
    http://www.ncbi.nlm.nih.gov/pubmed/8255414
    http://www.ncbi.nlm.nih.gov/pubmed/19837490
    http://www.ncbi.nlm.nih.gov/pubmed/4303377
    http://www.ncbi.nlm.nih.gov/pubmed/5535207
    http://www.ncbi.nlm.nih.gov/pubmed/10600217
    http://www.ncbi.nlm.nih.gov/pubmed/8598500
    http://www.ncbi.nlm.nih.gov/pubmed/9491439
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