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    Clinical Trial Results:
    Randomised, double-blind trial to compare the treatment effects of Ginkgo biloba extract EGb 761® and pentoxifylline in patients with sub-chronic and chronic tinnitus focussing on psycho-social problems

    Summary
    EudraCT number
    		 2011-004697-28
    Trial protocol
    		 CZ  
    Global end of trial date
    22 Aug 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Mar 2016
    First version publication date
    06 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    523001.01.099
    Additional study identifiers
    ISRCTN number
    		 ISRCTN68772788
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dr. W. Schwabe GmbH & Co. KG
    Sponsor organisation address
    Willmar Schwabe Str. 4, Karlsruhe, Germany, 76227
    Public contact
    Clinical Research Department, Dr. W. Schwabe GmbH & Co. KG, +49 72140058573,
    Scientific contact
    Clinical Research Department, Dr. W. Schwabe GmbH & Co. KG, +49 7214005573,
    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
    05 Aug 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Aug 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the treatment effects of Ginkgo biloba extract EGb 761® and pentoxifylline in patients with sub-chronic or chronic tinnitus focussing on psycho-social problems
    Protection of trial subjects
    Possibility to withdraw consent by patient. Monitoring of adverse events and laboratory parameters.
    Background therapy
    		 -
    Evidence for comparator
    		 Pentoxifylline improves haemorrheology and tissue perfusion by increasing red blood cell deformability and decreasing blood viscosity. It inhibits the aggregation of red blood cells and thrombocytes and decreases plasma fibrinogen levels. Pentoxifylline also inhibits the activation of leucocytes and their adhesion to the endothelium. The drug is registered and frequently prescribed to treat disorders of the inner ear that are related to impaired perfusion.
    Actual start date of recruitment
    13 Sep 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
    Czech Republic: 202
    Worldwide total number of subjects
    202
    EEA total number of subjects
    202
    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)
    164
    From 65 to 84 years
    38
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 In total, 202 patients were screened for inclusion into the trial. Two patients were not randomized and did not receive the investigational product since they terminated the trial before randomization and dispensation of the investigational product.

    Pre-assignment period milestones
    Number of subjects started
    		 202
    Number of subjects completed
    		 200

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 lost to follow-up: 2
    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 EGb 761®
    Arm description
    		 Film-coated tablets containing 120 mg of Gingko biloba special extract EGb 761® (SMC: 5560) and pentoxifylline-placebo tablets (SMC: 9076P). One patient was randomized and started treatment but had no post-baseline measurements of the 11-Point Box Scales during the randomized 12-week treatment period and did not undergo at least 42 days of observation. The patient was excluded from the FAS.
    Arm type
    		 Experimental

    Investigational medicinal product name
    EGb 761®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet in the morning and one tablet in the evening for 12 consecutive weeks. Each tablet contains 120 mg of Gingko biloba special extract EGb 761®.

    Investigational medicinal product name
    Pentoxifylline-placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet pentoxifylline-placebo in the morning and one tablet pentoxifylline-placebo in the evening for 12 consecutive weeks. The tablet pentoxifylline-placebo and the film-coated EGb 761® tablet were to be swallowed as a whole with some liquid.

    Arm title
    		 Pentoxifylline
    Arm description
    		 Extended-release tablets containing 600 mg of pentoxifylline (SMC: 9076) and EGb 761®-placebo film-coated tables (SMC: 5560P). Two patients were randomized and started treatment but had no post-baseline measurements of the 11-Point Box Scales during the randomized 12-week treatment period. One of those two patients did not undergo at least 42 days of observation and the other patient did not show a compliance between 80% and 120% for the first 42 days of observation. Both patients were excluded from the FAS.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Pentoxifylline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet in the morning and one tablet in the evening for 12 consecutive weeks. Each tablet contains 600 mg of pentoxifylline.

    Investigational medicinal product name
    EGb 761®-placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet EGb 761®-placebo in the morning and one tablet EGb 761®-placebo in the evening for 12 consecutive weeks. The tablet EGb 761®-placebo and the extended release pentoxifylline tablet were to be swallowed as a whole with some liquid.

    Number of subjects in period 1 [1]
    		EGb 761® Pentoxifylline
    Started
    100
    100
    Completed
    93
    83
    Not completed
    7
    17
         Consent withdrawn by subject
    -
    1
         Physician decision
    -
    1
         Adverse event, non-fatal
    6
    14
         Private reasons
    1
    -
         Lost to follow-up
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: In total, 2 of the 202 subjects screened for inclusion into the trial were not included into the baseline period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    EGb 761®
    Reporting group description
    		 Film-coated tablets containing 120 mg of Gingko biloba special extract EGb 761® (SMC: 5560) and pentoxifylline-placebo tablets (SMC: 9076P). One patient was randomized and started treatment but had no post-baseline measurements of the 11-Point Box Scales during the randomized 12-week treatment period and did not undergo at least 42 days of observation. The patient was excluded from the FAS.

    Reporting group title
    Pentoxifylline
    Reporting group description
    		 Extended-release tablets containing 600 mg of pentoxifylline (SMC: 9076) and EGb 761®-placebo film-coated tables (SMC: 5560P). Two patients were randomized and started treatment but had no post-baseline measurements of the 11-Point Box Scales during the randomized 12-week treatment period. One of those two patients did not undergo at least 42 days of observation and the other patient did not show a compliance between 80% and 120% for the first 42 days of observation. Both patients were excluded from the FAS.

    Reporting group values
    		 EGb 761® Pentoxifylline Total
    Number of subjects
    		 100 100 200
    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)
    		 77 85 162
        From 65-84 years
    		 23 15 38
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55.3 ( 10.48 ) 53 ( 10.84 ) -
    Gender categorical
    Units: Subjects
        Female
    		 41 39 80
        Male
    		 59 61 120
    Subject analysis sets

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full analysis set (FAS) included all subjects who received an investigational product at least once and had at least one post-baseline measurement of one of the 11-Point Box Scales. Subjects that dropped out after dispensation of the investigational product without measurements of the 11-Point Box Scales for both parameters during the randomised treatment period and intake of the investigational product at least once were included in the FAS if they had at least 42 days of observation, a compliance between 80% and 120% for this period and at least one of the following conditions was met for the reason of drop out: 1) “Lack of efficacy" or “Unexpected improvement/ remission of disease relevant for trial indication” or 2) “Adverse event" and a causal relationship of the AE with the investigational product was not excluded (causal relationship assessed as "unlikely", "possible" or "probable")

    Subject analysis sets values
    		 Full analysis set
    Number of subjects
    197
    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)
    159
        From 65-84 years
    38
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    54.3 ( 10.75 )
    Gender categorical
    Units: Subjects
        Female
    80
        Male
    117

    End points

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    End points reporting groups
    Reporting group title
    EGb 761®
    Reporting group description
    		 Film-coated tablets containing 120 mg of Gingko biloba special extract EGb 761® (SMC: 5560) and pentoxifylline-placebo tablets (SMC: 9076P). One patient was randomized and started treatment but had no post-baseline measurements of the 11-Point Box Scales during the randomized 12-week treatment period and did not undergo at least 42 days of observation. The patient was excluded from the FAS.

    Reporting group title
    Pentoxifylline
    Reporting group description
    		 Extended-release tablets containing 600 mg of pentoxifylline (SMC: 9076) and EGb 761®-placebo film-coated tables (SMC: 5560P). Two patients were randomized and started treatment but had no post-baseline measurements of the 11-Point Box Scales during the randomized 12-week treatment period. One of those two patients did not undergo at least 42 days of observation and the other patient did not show a compliance between 80% and 120% for the first 42 days of observation. Both patients were excluded from the FAS.

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full analysis set (FAS) included all subjects who received an investigational product at least once and had at least one post-baseline measurement of one of the 11-Point Box Scales. Subjects that dropped out after dispensation of the investigational product without measurements of the 11-Point Box Scales for both parameters during the randomised treatment period and intake of the investigational product at least once were included in the FAS if they had at least 42 days of observation, a compliance between 80% and 120% for this period and at least one of the following conditions was met for the reason of drop out: 1) “Lack of efficacy" or “Unexpected improvement/ remission of disease relevant for trial indication” or 2) “Adverse event" and a causal relationship of the AE with the investigational product was not excluded (causal relationship assessed as "unlikely", "possible" or "probable")

    Primary: Change in 11-Point Box Scales for tinnitus loudness between baseline and end of treatment

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    End point title
    		 Change in 11-Point Box Scales for tinnitus loudness between baseline and end of treatment
    End point description
    The 11-Point Box Scales for tinnitus loudness and annoyance were assessed at each day during the trial. The evaluation of the scales was based on mean weekly values per subject. The baseline value was determined by calculating the mean of all documented assessments from the screening visit onwards (including) until randomization. Note: No formal hypotheses were formulated, there was no formal differentiation between primary and secondary end points and data were analyzed descriptively. The effectiveness of EGb 761® in comparison to pentoxifylline was described primarily using the changes of the 11-point box scales for tinnitus loudness and annoyance and the changes of the Mini-TQ total score during the 12 weeks of treatment.
    End point type
    Primary
    End point timeframe
    Baseline and End of Treatment (12-week treatment period)
    End point values
    		 EGb 761® Pentoxifylline
    Number of subjects analysed
    99
    98
    Units: points
        arithmetic mean (standard deviation)
    -0.4 ( 1.34 )
    -0.45 ( 1.3 )
    Statistical analysis title
    		 ANCOVA
    Statistical analysis description
    ANCOVA with factor treatment and the respective baseline score as covariate, LOCF method was used
    Comparison groups
    EGb 761® v Pentoxifylline
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.36
         upper limit
    		 0.39
    Notes
    [1] - The confidence intervals of differences of LS means were computed to compare the effectiveness of the treatments. Difference EGb 761® - Pentoxifylline was calculated.

    Primary: Change in 11-Point Box Scales for tinnitus annoyance between baseline and end of treatment

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    End point title
    		 Change in 11-Point Box Scales for tinnitus annoyance between baseline and end of treatment
    End point description
    The 11-Point Box Scales for tinnitus loudness and annoyance were assessed at each day during the trial. The evaluation of the scales was based on mean weekly values per subject. The baseline value was determined by calculating the mean of all documented assessments from the screening visit onwards (including) until randomization. Note: No formal hypotheses were formulated, there was no formal differentiation between primary and secondary end points and data were analyzed descriptively. The effectiveness of EGb 761® in comparison to pentoxifylline was described primarily using the changes of the 11-point box scales for tinnitus loudness and annoyance and the changes of the Mini-TQ total score during the 12 weeks of treatment.
    End point type
    Primary
    End point timeframe
    Baseline and End of Treatment (12-week treatment period)
    End point values
    		 EGb 761® Pentoxifylline
    Number of subjects analysed
    99
    98
    Units: points
        arithmetic mean (standard deviation)
    -0.54 ( 1.48 )
    -0.56 ( 1.4 )
    Statistical analysis title
    		 ANCOVA
    Statistical analysis description
    ANCOVA with factor treatment and respective baseline score as covariate, LOCF method was used.
    Comparison groups
    EGb 761® v Pentoxifylline
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.42
         upper limit
    		 0.39
    Notes
    [2] - The confidence intervals of differences of LS means were computed to compare the effectiveness of the treatments. Difference EGb 761® - Pentoxifylline was calculated.

    Primary: Change in Abridged Tinnitus Questionnaire (Mini-TQ) between baseline and end of treatment

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    End point title
    		 Change in Abridged Tinnitus Questionnaire (Mini-TQ) between baseline and end of treatment
    End point description
    The abridged Tinnitus Questionnaire (Mini-TQ) includes 12 items with questions related to the subjective perception of coping attitudes and beliefs about tinnitus. Each item of the questionnaire is to be rated on a 3-point scale (2=true, 1=partly true, 0=not true). The maximum score is 24 points with higher scores indicating more severe distress. Note: No formal hypotheses were formulated, there was no formal differentiation between primary and secondary end points and data were analyzed descriptively. The effectiveness of EGb 761® in comparison to pentoxifylline was described primarily using the changes of the 11-point box scales for tinnitus loudness and annoyance and the changes of the Mini-TQ total score during the 12 weeks of treatment.
    End point type
    Primary
    End point timeframe
    Baseline and End of Treatment (12-week treatment period)
    End point values
    		 EGb 761® Pentoxifylline
    Number of subjects analysed
    95
    90
    Units: Points
        arithmetic mean (standard deviation)
    -1.55 ( 3.06 )
    -1.97 ( 3.73 )
    Statistical analysis title
    		 ANCOVA
    Statistical analysis description
    ANCOVA with factor treatment and respective baseline score as covariate, LOCF method was used.
    Comparison groups
    EGb 761® v Pentoxifylline
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 1.35
    Notes
    [3] - The confidence intervals of differences of LS means were computed to compare the effectiveness of the treatments. Difference EGb 761® - Pentoxifylline was calculated.

    Secondary: Change in anxiety score of Hospital Anxiety and Depression Scale (HADS) between baseline and end of treatment

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    End point title
    		 Change in anxiety score of Hospital Anxiety and Depression Scale (HADS) between baseline and end of treatment
    End point description
    The HADS contains of 14 questions, of which seven each are assigned to anxiety and to depression. The answers to each question are rated on a scale from 0 to 3, with higher scores corresponding to a higher degree of anxiety or depression. Note: Mean changes (+95%-CIs) from baseline to week 12 for EGb 761® and pentoxifylline were used to compare the two treatments descriptively.
    End point type
    Secondary
    End point timeframe
    Baseline and End of Treatment (12-week treatment period)
    End point values
    		 EGb 761® Pentoxifylline
    Number of subjects analysed
    95
    90
    Units: points
        arithmetic mean (confidence interval 95%)
    -1.3 (-1.82 to -0.85)
    -1.1 (-1.55 to -0.56)
    No statistical analyses for this end point

    Secondary: Change in depression score of Hospital Anxiety and Depression Scale (HADS) between baseline and end of treatment

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    End point title
    		 Change in depression score of Hospital Anxiety and Depression Scale (HADS) between baseline and end of treatment
    End point description
    The HADS contains of 14 questions, of which seven each are assigned to anxiety and to depression. The answers to each question are rated on a scale from 0 to 3, with higher scores corresponding to a higher degree of anxiety or depression. Note: Mean changes (+95%-CIs) from baseline to week 12 for EGb 761® and pentoxifylline were used to compare the two treatments descriptively.
    End point type
    Secondary
    End point timeframe
    Baseline and End of Treatment (12-week treatment period)
    End point values
    		 EGb 761® Pentoxifylline
    Number of subjects analysed
    95
    90
    Units: Points
        arithmetic mean (confidence interval 95%)
    -0.4 (-0.89 to 0.15)
    -0.5 (-0.92 to 0.01)
    No statistical analyses for this end point

    Secondary: Change in global impairment score of the Sheehan Disability Score (SDS) between baseline and end of treatment

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    End point title
    		 Change in global impairment score of the Sheehan Disability Score (SDS) between baseline and end of treatment
    End point description
    The Sheehan Disability Scale is a brief self-report (patient-rated) inventory. All items are scored on a 0-10 scale, where 0 represents no impairment, 1-3 mild impairment, 4-6 moderate impairment, 7-9 marked impairment and 10 extreme impairment. A total score named “global impairment” is calculated as the sum of the first three items of the questionnaire.
    End point type
    Secondary
    End point timeframe
    Baseline and End of Treatment (12-week treatment period)
    End point values
    		 EGb 761® Pentoxifylline
    Number of subjects analysed
    94
    90
    Units: Points
        arithmetic mean (standard deviation)
    -1.67 ( 4.9 )
    -1.88 ( 5.41 )
    Statistical analysis title
    		 ANCOVA
    Statistical analysis description
    ANCOVA with factor treatment and respective score as covariate, LOCF method was used
    Comparison groups
    EGb 761® v Pentoxifylline
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.69
         upper limit
    		 1.02
    Notes
    [4] - The confidence intervals of differences of LS means were computed to compare the effectiveness of the treatments. Difference EGb 761® - Pentoxifylline was calculated.

    Secondary: Change of Item 4 score of the Sheehan Disability Scale (SDS)

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    End point title
    		 Change of Item 4 score of the Sheehan Disability Scale (SDS)
    End point description
    Number of days lost in the last week (with regard to missed school or work or unable to carry out normal daily responsibilities)
    End point type
    Secondary
    End point timeframe
    Baseline and End of Treatment (12-week treatment period)
    End point values
    		 EGb 761® Pentoxifylline
    Number of subjects analysed
    95
    90
    Units: Points
        arithmetic mean (standard deviation)
    0.01 ( 0.23 )
    -0.07 ( 0.95 )
    Statistical analysis title
    		 ANCOVA
    Statistical analysis description
    ANCOVA with factor treatment and respective baseline score as covariate, LOCF method was used
    Comparison groups
    Pentoxifylline v EGb 761®
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.16
         upper limit
    		 0.12
    Notes
    [5] - The confidence intervals of differences of LS means were computed to compare the effectiveness of the treatments. Difference EGb 761® - Pentoxifylline was calculated.

    Secondary: Change of Item 5 score of the Sheehan Disability Scale (SDS)

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    End point title
    		 Change of Item 5 score of the Sheehan Disability Scale (SDS)
    End point description
    Number of days with reduced productivity (with regard to school, work)
    End point type
    Secondary
    End point timeframe
    Baseline and End of Treatment (12-week treatment period)
    End point values
    		 EGb 761® Pentoxifylline
    Number of subjects analysed
    95
    90
    Units: Points
        arithmetic mean (standard deviation)
    -0.32 ( 1.51 )
    -0.22 ( 1.8 )
    Statistical analysis title
    		 ANCOVA
    Statistical analysis description
    ANCOVA with factor treatment and respective baseline score as covariate, LOCF method was used
    Comparison groups
    EGb 761® v Pentoxifylline
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.54
         upper limit
    		 0.11
    Notes
    [6] - The confidence intervals of differences of LS means were computed to compare the effectiveness of the treatments. Difference EGb 761® - Pentoxifylline was calculated.

    Secondary: Speech audiometry: percentage of words comprehended with sound level 60 dB with the right ear

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    End point title
    		 Speech audiometry: percentage of words comprehended with sound level 60 dB with the right ear
    End point description
    The change between baseline and end of treatment was evaluated for the percentage of words comprehended. Note: Mean changes (+95%-CIs) from baseline to week 12 for EGb 761® and pentoxifylline were used to compare the two treatments descriptively.
    End point type
    Secondary
    End point timeframe
    Baseline and End of Treatment (12-week treatment period)
    End point values
    		 EGb 761® Pentoxifylline
    Number of subjects analysed
    93
    83
    Units: Percentage
        arithmetic mean (confidence interval 95%)
    1.6 (-1.27 to 4.5)
    1.9 (-0.47 to 4.33)
    No statistical analyses for this end point

    Secondary: Speech audiometry: percentage of words comprehended with sound level 60 dB with the left ear

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    End point title
    		 Speech audiometry: percentage of words comprehended with sound level 60 dB with the left ear
    End point description
    The change between baseline and end of treatment was evaluated for the percentage of words comprehended. Note: Mean changes (+95%-CIs) from baseline to week 12 for EGb 761® and pentoxifylline were used to compare the two treatments descriptively.
    End point type
    Secondary
    End point timeframe
    Baseline and End of Treatment (12-week treatment period)
    End point values
    		 EGb 761® Pentoxifylline
    Number of subjects analysed
    93
    83
    Units: Percentage
        arithmetic mean (confidence interval 95%)
    0.2 (-1.97 to 2.29)
    -0.6 (-2.21 to 1.01)
    No statistical analyses for this end point

    Secondary: Speech audiometry: percentage of words comprehended with sound level 80 dB with the right ear

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    End point title
    		 Speech audiometry: percentage of words comprehended with sound level 80 dB with the right ear
    End point description
    The change between baseline and end of treatment was evaluated for the percentage of words comprehended. Note: Mean changes (+95%-CIs) from baseline to week 12 for EGb 761® and pentoxifylline were used to compare the two treatments descriptively.
    End point type
    Secondary
    End point timeframe
    Baseline and End of Treatment (12-week treatment period)
    End point values
    		 EGb 761® Pentoxifylline
    Number of subjects analysed
    93
    83
    Units: Percentage
        arithmetic mean (confidence interval 95%)
    1.4 (-0.65 to 3.45)
    1.4 (-1.26 to 4.16)
    No statistical analyses for this end point

    Secondary: Speech audiometry: percentage of words comprehended with sound level 80 dB with the left ear

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    End point title
    		 Speech audiometry: percentage of words comprehended with sound level 80 dB with the left ear
    End point description
    The change between baseline and end of treatment was evaluated for the percentage of words comprehended. Note: Mean changes (+95%-CIs) from baseline to week 12 for EGb 761® and pentoxifylline were used to compare the two treatments descriptively.
    End point type
    Secondary
    End point timeframe
    Baseline and End of Treatment (12-week treatment period)
    End point values
    		 EGb 761® Pentoxifylline
    Number of subjects analysed
    93
    83
    Units: Percentage
        arithmetic mean (confidence interval 95%)
    2.1 (0.09 to 4.1)
    0 (-0.76 to 0.76)
    No statistical analyses for this end point

    Secondary: Speech audiometry: percentage of words comprehended with sound level 100 dB with the right ear

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    End point title
    		 Speech audiometry: percentage of words comprehended with sound level 100 dB with the right ear
    End point description
    The change between baseline and end of treatment was evaluated for the percentage of words comprehended. Note: Mean changes (+95%-CIs) from baseline to week 12 for EGb 761® and pentoxifylline were used to compare the two treatments descriptively.
    End point type
    Secondary
    End point timeframe
    Baseline and End of Treatment (12-week treatment period)
    End point values
    		 EGb 761® Pentoxifylline
    Number of subjects analysed
    93
    83
    Units: Percentage
        arithmetic mean (confidence interval 95%)
    -0.3 (-4.02 to 3.38)
    3.4 (-0.27 to 7.13)
    No statistical analyses for this end point

    Secondary: Speech audiometry: percentage of words comprehended with sound level 100 dB with the left ear

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    End point title
    		 Speech audiometry: percentage of words comprehended with sound level 100 dB with the left ear
    End point description
    The change between baseline and end of treatment was evaluated for the percentage of words comprehended. Note: Mean changes (+95%-CIs) from baseline to week 12 for EGb 761® and pentoxifylline were used to compare the two treatments descriptively.
    End point type
    Secondary
    End point timeframe
    Baseline and End of Treatment (12-week treatment period)
    End point values
    		 EGb 761® Pentoxifylline
    Number of subjects analysed
    93
    83
    Units: Percentage
        arithmetic mean (confidence interval 95%)
    0.1 (-3.17 to 3.38)
    2.1 (-1.59 to 5.81)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 weeks + 2 days
    Adverse event reporting additional description
    During the active treatment and subsequent risk phase 19/100 (19.0%) subjects from the EGb 761® group experienced a total of 20 AEs leading to an overall incidence rate of 0.0024 AEs/day of exposure. In the pentoxifylline group 27/100 (27.0%) subjects experienced a total of 36 AEs leading to an overall incidence rate of 0.0048 AEs/day of exposure.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    PENTOXIFYLLINE
    Reporting group description
    		 Active comparator

    Reporting group title
    EGb 761
    Reporting group description
    		 Active treatment

    Reporting group title
    No active treatment
    Reporting group description
    		 No active treatment

    Serious adverse events
    		 PENTOXIFYLLINE EGb 761 No active treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PENTOXIFYLLINE EGb 761 No active treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 100 (3.00%)
    5 / 100 (5.00%)
    0 / 200 (0.00%)
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    3 / 100 (3.00%)
    5 / 100 (5.00%)
    0 / 200 (0.00%)
         occurrences all number
    3
    5
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Jul 2012
    The trial schedule was changed because due to organisational reasons the start of patients´ recruitment had to be adjusted. Inclusion criterion 1 was changed to allow the enrolment of subjects aged between 30 and 40 years in addition. Exclusion criterion “12 Alcohol or substance addiction or abuse (i.e. consumption at higher quantities or frequencies than generally socially accepted) within the last 10 years“ was added. In the section describing forbidden concomitant therapy the use of anti-epileptic drugs was added. The patient information and informed consent form (Final version from 08 March 2012) had been linguistically revised.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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