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    Clinical Trial Results:
    Double-blind, randomised, placebo-controlled study evaluating the efficacy and Safety of Tavipec® capsules in acute Rhinosinusitis A prospective, multi-centre, parallel group, interventional clinical phase IV study

    Summary
    EudraCT number
    		 2013-002977-23
    Trial protocol
    		 AT   PL  
    Global end of trial date
    24 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Jul 2022
    First version publication date
    31 Jul 2022
    Other versions
    Summary report(s)
    		 TAV02-13_Synospsis_Final Study Report

    Trial information

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    Trial identification
    Sponsor protocol code
    TAV2-13
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pharmazeutische Fabrik Montavit Ges.m.b.H.
    Sponsor organisation address
    Salzbergstraße 96, Absam, Austria, 6067
    Public contact
    Head of the Clinical Trial Department, Montavit Head Quarter Mag. Gabriele Zacke, 0043 0522357926234, gabriele.zacke@montavit.com
    Scientific contact
    Head of the Clinical Trial Department, Montavit Head Quarter Mag. Gabriele Zacke, 0043 0522357926234, gabriele.zacke@montavit.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
    11 Oct 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Oct 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Mean difference of an investigator-evaluated Major Symptom Score (MSS) of 20% between the verum group and the placebo group after 4 days of full medication dose
    Protection of trial subjects
    Acute rhinosinusitis is generally a self-limiting disease and care for acute rhinosinusitis is primarily supportive and aims on alleviation of symptoms. Therefore, no problems of ethics, acceptability, and feasibility are assumed to arise from the use of a placebo-concurrent control group. Patients were advised about re-consulting at any time during the study if there was a significant worsening of symptoms or occurrence of complications. For safety reason, these subjects would have been deemed clinical failures and promptly scheduled for a treatment failure visit. A close monitoring of patients was done. After baseline next evaluation was performed following four days of treatment, so the detection of a possible worsening of the clinical condition has been guaranteed. In case of treatment failure at this time point, treatment would have been discontinued.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Nov 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
    Poland: 222
    Country: Number of subjects enrolled
    Austria: 46
    Worldwide total number of subjects
    268
    EEA total number of subjects
    268
    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)
    251
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited between Jan 2014 and Oct 2016 in 4 study sites in Austria and in 6 study sites in Poland by general practitioner, specialist of ENT or by hospital doctors from ENT clinics. Moreover, recruitment advertising campaigns in Vienna and Innsbruck were carried out (e.g. posters and postcards, which were released by ECs).

    Pre-assignment
    Screening details
    		 There was no screening period as it was an acute treatment. Only patients suffering from uncomplicated acute viral rhinosinusitis with onset of first symptoms within two days before start of treatment were recruited. In summery, 288 patients were assessed for eligibility (safety group) of which 20 patients were excluded after inclusion (n= 268).

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    The IMPs were supplied in a double blind way. Each patient received a medication bottle with capsules. In the placebo group the bottles contained placebo identical in appearance, shape and taste to verum, being indistinguishable from their respective active investigational drug. Neither the labelled bottle nor the capsules of the placebo and the verum group differ. Moreover, Investigators received an emergency envelope of each patient. During the conduct of the trial no unblinding was performed

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 In summary 288 patients were assessed and randomised. Placebo (n = 141) 9 patients were excluded after inclusion: - Not meeting inclusion criteria (n = 7) - Not allowed concomitant medication (n = 1) - No pregnancy test done (n = 1)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo capsules, enteric-coated
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo capsules with gastroresistant coating were filled with medium-chain triglycerides. Patients were instructed to swallow placebo capsules as a whole with some liquid, 30 minutes before a meal. The application was three times daily two capsules (2-2-2)

    Arm title
    		 Tavipec
    Arm description
    		 In summary 288 patients were assessed and randomised. Tavipec group (n = 147) 11 patients were excluded after inclusion: - Not meeting inclusion criteria (n = 8) - Not allowed concomitant medication (n = 1) - Use of expired drug (n = 1) - No pregnancy test done (n = 1)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tavipec® capsule, enteric-coated
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Tavipec capsules with gastroresistant coating contained 150 mg Spicae aetheroleum (per capsule) as the active ingredient. Patients were instructed to swallow Tavipec capsules as a whole with some liquid, 30 minutes before a meal. The application was three times daily two capsules (2-2-2)

    Number of subjects in period 1
    		Placebo Tavipec
    Started
    132
    136
    Follow-up
    132
    136
    PP Analysis day 5
    125
    128
    PP Analysis day 8
    116
    122
    Completed
    116
    122
    Not completed
    16
    14
         Consent withdrawn by subject
    9
    8
         Adverse event, non-fatal
    -
    1
         Need for antibiotic treatment
    6
    5
         Retrospective data entry
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 In summary 288 patients were was assessed for eligibility and randomised ( Tavipec = 147 patients / Placebo = 141 patients). This number of patients was considered as Safety population (Safety analysis). 11 patients were excluded after Inclusion in the Tavipec group (n = 136) and 9 patients were excluded after Inclusion in the Placebo group (n = 132). This was considered as intended-to-treat (ITT) population, which received allocated intervention at least once.

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 268 268
    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 (full range (min-max))
    		 39.4020 (18 to 74) -
    Gender categorical
    Units: Subjects
        Female
    		 150 150
        Male
    		 118 118
    Weight
    Units: kg
        arithmetic mean (full range (min-max))
    		 74,0493 (44,20 to 136) -
    Height
    Units: cm
        arithmetic mean (full range (min-max))
    		 172.26 (154 to 196) -
    Body temperature
    Units: °C
        arithmetic mean (full range (min-max))
    		 37.1412 (34.20 to 38.20) -
    Onset of rhinosinusitis
    Units: day
        arithmetic mean (standard deviation)
    		 2.2351 ( 0.73487 ) -
    MSS at baseline
    MSS = major symptom score
    Units: MSS
        arithmetic mean (standard deviation)
    		 8.6866 ( 1.29775 ) -
    Subject analysis sets

    Subject analysis set title
    Placebo group
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Received allocated intervention at least once (ITT-population)

    Subject analysis set title
    Tavipec group
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Received allocated intervention at least once (ITT-population)

    Subject analysis sets values
    		 Placebo group Tavipec group
    Number of subjects
    132
    136
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    40.447 (18 to 74)
    38,3897 (18 to 72)
    Gender categorical
    Units: Subjects
        Female
    70
    80
        Male
    62
    56
    Weight
    Units: kg
        arithmetic mean (full range (min-max))
    73.9129 (48.00 to 118.00)
    74.1816 (44.20 to 136.00)
    Height
    Units: cm
        arithmetic mean (full range (min-max))
    171.92 (154 to 190)
    172.60 (156 to 196)
    Body temperature
    Units: °C
        arithmetic mean (full range (min-max))
    37.0908 (34.20 to 38.20)
    37.1897 (34.80 to 38.20)
    Onset of rhinosinusitis
    Units: day
        arithmetic mean (standard deviation)
    2.2045 ( 0.72826 )
    2.2647 ( 0.74272 )
    MSS at baseline
    MSS = major symptom score
    Units: MSS
        arithmetic mean (standard deviation)
    8.6288 ( 1.32161 )
    8.7426 ( 1.27655 )

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 In summary 288 patients were assessed and randomised. Placebo (n = 141) 9 patients were excluded after inclusion: - Not meeting inclusion criteria (n = 7) - Not allowed concomitant medication (n = 1) - No pregnancy test done (n = 1)

    Reporting group title
    Tavipec
    Reporting group description
    		 In summary 288 patients were assessed and randomised. Tavipec group (n = 147) 11 patients were excluded after inclusion: - Not meeting inclusion criteria (n = 8) - Not allowed concomitant medication (n = 1) - Use of expired drug (n = 1) - No pregnancy test done (n = 1)

    Subject analysis set title
    Placebo group
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Received allocated intervention at least once (ITT-population)

    Subject analysis set title
    Tavipec group
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Received allocated intervention at least once (ITT-population)

    Primary: Mean difference of an investigator-evaluated MSS between the verum group and the placebo group after 4 days of full medication dose (PP day 5)

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    End point title
    		 Mean difference of an investigator-evaluated MSS between the verum group and the placebo group after 4 days of full medication dose (PP day 5)
    End point description
    Primary efficacy evaluation was the mean difference of an investigator-evaluated MSS (of >5 and <12 (of a maximum 15 score points)) of 20 % between the verum and placebo group after 4 days of full medication dose. During a 4-day treatment course the MSS improved by a mean of 3,7266 and 3,0800 score points in the Tavipec and placebo group, respectively in the PP day 5 population. Resulting in a difference between both groups of 0,6466 score points. The difference between both groups in terms of improvement was in favour of Tavipec, however reached no statistical significance.
    End point type
    Primary
    End point timeframe
    Assessed after 4 days of full medication dose (PP day 5)
    End point values
    		 Placebo group Tavipec group
    Number of subjects analysed
    125 [1]
    128 [2]
    Units: MSS
    arithmetic mean (standard deviation)
        MSS Diff
    3.080 ( 2.52 )
    3.727 ( 2.04 )
    Notes
    [1] - PP-population
    [2] - PP-population
    Statistical analysis title
    		 2-sided (α= 5%) Mann-Whitney test (rank-sum test)
    Statistical analysis description
    Primary efficacy parameter was the mean difference of an investigator-evaluated Major Symptom Score (of >5 & <12 (of max. 15 score points)) of 20% between the Tavipec and Placebo group after 4 days of full medication dose. A sum sore from signs and symptoms was formed (0= none, 1 = mild, 2 = moderate, 3 = severe), comparing changes from baseline in both treatment groups.
    Comparison groups
    Placebo group v Tavipec group
    Number of subjects included in analysis
    253
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation
    Notes
    [3] - The main efficacy variable is quantitative, however, not necessarily normally distributed; therefore a two-sided (α= 5%) Mann-Whitney test (rank-sum test) was applied to test the following hypothesis (null hypothesis): H0: μ MSS (day 5) placebo = μ MSS (day 5) verum H1: μ MSS (day 5) placebo ≠ μ MSS (day 5) verum

    Secondary: Mean difference of an investigator-evaluated MSS between the verum group and the placebo group after 7 days of full medication dose (PP day 8)

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    End point title
    		 Mean difference of an investigator-evaluated MSS between the verum group and the placebo group after 7 days of full medication dose (PP day 8)
    End point description
    After 7 days of full medication dose the mean change of MSS from baseline was 6.1885 score points in the Tavipec group and 5.0689 score points in the placebo group. The Mann-Whitney test shows a significance level of p = 0.049. Thus it can be concluded that the MSS at day 8 for the Tavipec group is significantly lower than in the placebo group. Taking the aimed 20 % difference into account the significance level decreases to p = 0.893
    End point type
    Secondary
    End point timeframe
    Assessed after 7 days of full medication dose (PP day 8)
    End point values
    		 Placebo group Tavipec group
    Number of subjects analysed
    116 [4]
    122 [5]
    Units: MSS
    arithmetic mean (standard deviation)
        MSS day 0
    8.5948 ( 1.29197 )
    8.7295 ( 1.27944 )
        MSS day 7
    3.5259 ( 2.83905 )
    2.5410 ( 1.76816 )
    Notes
    [4] - PP-population day 8
    [5] - PP-population day 8
    Statistical analysis title
    		 2-sided (α= 5%) Mann-Whitney test (rank-sum test)
    Comparison groups
    Tavipec group v Placebo group
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Mean difference of the adapted investigator-evaluated MSS of 20% between the verum group and the placebo group after 4 days of full medication dose (PP day 5)

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    End point title
    		 Mean difference of the adapted investigator-evaluated MSS of 20% between the verum group and the placebo group after 4 days of full medication dose (PP day 5)
    End point description
    During a 4-day treatment course the adapted MSS dropped from 10.4375 and 10.3280 score points in the Tavipec and placebo group, respectively at baseline to 5.9531 and 6.7040 score points at day 5, corresponding to an improvement of 4.4844 and 3.6240 score points in those patients. The difference between both groups in terms of improvement was in favour of Tavipec, however reached no statistical significance (p = 0.065). Taking the aimed 20 % difference into account, the significance level decrease to p = 0.456.
    End point type
    Secondary
    End point timeframe
    Assessed after 4 days of full medication dose (PP day 5).
    End point values
    		 Placebo group Tavipec group
    Number of subjects analysed
    125 [6]
    128 [7]
    Units: MSS
    arithmetic mean (standard deviation)
        adapted MSS day 0
    10.3280 ( 1.58509 )
    10.4375 ( 1.44042 )
        adapted MSS day 5
    6.7040 ( 3.26028 )
    5.9531 ( 2.58968 )
    Notes
    [6] - PP-population (day 5)
    [7] - PP-population (day 5)
    Statistical analysis title
    		 2-sided (α= 5%) Mann-Whitney test (rank-sum test)
    Comparison groups
    Tavipec group v Placebo group
    Number of subjects included in analysis
    253
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Mean difference of the adapted investigator-evaluated MSS of 20% between the verum group and the placebo group after 7 days of full medication dose

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    End point title
    		 Mean difference of the adapted investigator-evaluated MSS of 20% between the verum group and the placebo group after 7 days of full medication dose
    End point description
    As a secondary efficacy parameter the mean difference of an adapted investigator-evaluated MSS of 20% between the verum group and the placebo group after 7 days of full medication dose was evaluated. The analysis was performed on the PP-day 8 population, consisting of 238 subjects (122 Tavipec group, 116 placebo group). The difference of the adapted MSS (day 0 and day 8) was 7.4590 score points in the verum group and 5.9741 score points in the placebo group. The Mann-Whitney test shows significance level of p = 0.040 and it can be concluded that the adapted MSS at day 8 for the verum group is significantly lower than in the placebo group. Taking the aimed 20 % difference into account, the significance level decreased to p = 0.770.
    End point type
    Secondary
    End point timeframe
    Assessed after after 7 days of full medication dose
    End point values
    		 Placebo group Tavipec group
    Number of subjects analysed
    116 [8]
    122 [9]
    Units: MSS
    arithmetic mean (standard deviation)
        Adapted MSS day 0
    10.2500 ( 1.55968 )
    10.4590 ( 1.46670 )
        Adapted MSS day 8
    4.2759 ( 3.49555 )
    3.0000 ( 2.10862 )
    Notes
    [8] - PP-population day 8
    [9] - PP-population day 8
    Statistical analysis title
    		 2-sided (α= 5%) Mann-Whitney test (rank-sum test)
    Comparison groups
    Tavipec group v Placebo group
    Number of subjects included in analysis
    238
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Global impact of disease on QOL as assessed by patient

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    End point title
    		 Global impact of disease on QOL as assessed by patient
    End point description
    Patients were asked to rate the impact of symptoms on their quality of life on a verbal rating scale (VRS) ranging from 0 (not troublesome) to 10 (worst thinkable troublesome). Valuations from 0-3, 4-7 and 8-10 indicating mild, moderate and severe impact. The mean QoL score dropped from 6.84 at baseline to 3.60 after 4 days of full medication dose and to 1.60 score points after 7 days of full medication dose in the Tavipec group and from 6.91 at baseline, to 4.59 and 3.04 in the placebo group. The Mann-Whitney test shows a significane level of p = 0.0000027678 at day 5 and p=0,0000000051 at day 8 and therefore it can be concluded that the QoL score in the Tavipec group is significantly lower than for the placebo group after 4 and 7 days of full medication dose. Below, the results for day 0 and day 5 are shown. Complete Results are attachment.
    End point type
    Secondary
    End point timeframe
    Assessed after 4 and 7 days of full medication dose
    End point values
    		 Placebo group Tavipec group
    Number of subjects analysed
    125 [10]
    128 [11]
    Units: QOL score
    arithmetic mean (standard deviation)
        QoL day 0
    6.91 ( 1.556 )
    6.84 ( 1.673 )
        QoL day 5
    4.59 ( 1.972 )
    3.60 ( 1.638 )
    Attachments
    		 TAV02-13_Results sec. endpint_QoL
    Notes
    [10] - PP-population day 8
    [11] - PP-population (day 0 and day 5)
    Statistical analysis title
    		 2-sided (α= 5%) Mann-Whitney test (rank-sum test)
    Comparison groups
    Placebo group v Tavipec group
    Number of subjects included in analysis
    253
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: % of patients with improvement of health-related QOL score as revealed by SNOT-22 by at least ten score points

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    End point title
    		 % of patients with improvement of health-related QOL score as revealed by SNOT-22 by at least ten score points
    End point description
    Patients were asked to fill in the SNOT-22 questionnaire, a disease-specific, health-related quality-of-life-test comprising 22 items. Patients rated the severity of symptoms on a 6-point (0-5) Likert-scale, giving a total score ranging between 0 and 110 by summing up all the symptoms. Higher score indicating greater rhinosinusitis-related health burden. Below the results for SNOT-22 score points at day 0 and day 5 are shown. Complete results of % of patients with improvement of health-related QOL score as revealed by SNOT-22 by at least ten score points are shown in the attachment.
    End point type
    Secondary
    End point timeframe
    Assessed after 4 and 7 days of full medication dose
    End point values
    		 Placebo group Tavipec group
    Number of subjects analysed
    124
    128
    Units: SNOT score points
    arithmetic mean (standard deviation)
        SNOT-22 day 0
    43.5323 ( 19.05722 )
    27.5484 ( 18.90126 )
        SNOT-22 day 5
    46.6641 ( 19.05495 )
    24.2734 ( 15.12141 )
    Attachments
    		 TAV02-13_Results sec. endpoint_SNOT-22
    Statistical analysis title
    		 2-sided (α= 5%) Mann-Whitney test (rank-sum test)
    Comparison groups
    Placebo group v Tavipec group
    Number of subjects included in analysis
    252
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Chi-Square for SNOT-22
    Statistical analysis description
    Chi-Square tests for categorical variables
    Comparison groups
    Placebo group v Tavipec group
    Number of subjects included in analysis
    252
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Non-serious AEs assessed by the investigator have to be reported to Montavit by e-mail within 30 days from receipt. All SAEs have to be reported at latest within 24 hours of the first awareness of the event.
    Adverse event reporting additional description
    At each visit, all AEs either reported by the patient or observed by the investigator were evaluated and recorded into the CRF. Each AE was described by its duration, frequency, severity, its relationship to the trial medication, its influence on administration or study medication and a possible requirement of therapy.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Placebo group
    Reporting group description
    		 -

    Reporting group title
    Tavipec group
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo group Tavipec group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 141 (0.00%)
    0 / 147 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo group Tavipec group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 141 (5.67%)
    26 / 147 (17.69%)
    Investigations
    Blood pressure increased
    Additional description: Investigations (cardiac and vascular) Relationship to IMP: unlikely Severity: mild
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 147 (0.68%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
    Additional description: Relationship to IMP: possibly (n=1), unlikely (n=1) Severity: mild (n=1), moderate (n=1)
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 147 (1.36%)
         occurrences all number
    0
    2
    Ear and labyrinth disorders
    Vertigo
    Additional description: Relationship to IMP: Unlikely Severity: mild Relationship to Placebo: Unrelated Severity: moderate
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 147 (0.68%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Abdominal pain upper
    Additional description: Relationship to IMP: probably Severity: mild
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 147 (0.68%)
         occurrences all number
    0
    1
    Nausea
    Additional description: Relationship to IMP: possibly (n = 4) Severity: mild (n = 2), moderate (n = 2) Relationship to Placebo: possibly (n = 1) Severity: mild (n = 1)
         subjects affected / exposed
    1 / 141 (0.71%)
    4 / 147 (2.72%)
         occurrences all number
    1
    4
    Abdominal pain
    Additional description: Relationship to IMP: possibly (n = 13), unrelated (n = 1) Severity: mild (n = 7), moderate (n = 6), severe (n = 1) Relationship to Placebo: possibly (n = 2), unrelated (n = 1) Severity: mild (n = 3)
         subjects affected / exposed
    3 / 141 (2.13%)
    14 / 147 (9.52%)
         occurrences all number
    3
    14
    Appendicitis
    Additional description: Relationship to IMP: unrelated Severity: moderate
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 147 (0.68%)
         occurrences all number
    0
    1
    Diarrhoea
    Additional description: Relationship to IMP: possibly Severity: mild
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 147 (0.68%)
         occurrences all number
    0
    1
    Breath odour
    Additional description: Relationship to IMP: possibly Severity: mild
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 147 (0.68%)
         occurrences all number
    0
    1
    Dysgeusia
    Additional description: Relationship to IMP: probably Severity: mild
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 147 (0.68%)
         occurrences all number
    0
    1
    Feeling of fullness in abdomen
    Additional description: Relationship to Placebo: unlikely Severity: mild
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 147 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Menstrual discomfort
    Additional description: Relationship to IMP: unrelated Severity: mild
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 147 (0.68%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
    Additional description: Relationship to Placebo: unlikely Severity: mild
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 147 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Mental disorder
    Additional description: Relationship to IMP: unrelated Severity: mild
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 147 (0.68%)
         occurrences all number
    0
    1
    Sleep disturbance
    Additional description: Relationship to Placebo: unlikely Severity: moderate
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 147 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Tonsillitis
    Additional description: Relationship to IMP: unrelated Severity: mild
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 147 (0.68%)
         occurrences all number
    0
    1
    Herpes virus infection
    Additional description: Relationship to Placebo: unrelated Severity: mild
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 147 (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? Yes
    Date
    Amendment
    31 Jan 2014
    Additional study sites and centres in order to not fail to recruit to the original target within the specified time, it was decided to include additional study sites. Before site initiation visit 8 study centres withdrew their consent to participate after having been approved by the ethics committee, due to high administrative effort of conducting a clinical trial. The study was extended to Poland and six study centres have been included.

    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.
    n.a

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31210177
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    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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