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    Clinical Trial Results:
    Phase III study, double blind, placebo controlled, to evaluate the efficacy and the safety of an omega-3 based drug, in patients with primary tinnitus.

    Summary
    EudraCT number
    		 2015-003514-24
    Trial protocol
    		 IT  
    Global end of trial date
    17 Oct 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Apr 2022
    First version publication date
    27 Apr 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OLEV01/2015
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IBSA Farmaceutici Italia srl
    Sponsor organisation address
    Via Martiri di Cefalonia, 2, Lodi, Italy, 26900
    Public contact
    CRO, Informa PRO S.r.l., +39 065758926, segreteria@informa.pro
    Scientific contact
    CRO, Informa PRO S.r.l., +39 065758926, segreteria@informa.pro
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Nov 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Oct 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Oct 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluation of the efficacy and safety of Olevia (omega-3 polyunsatured acid based drug) in both genders patients affected by primary tinnitus.
    Protection of trial subjects
    Patients were monitored for any possible adverse events ocurred between each visits.
    Background therapy
    		 -
    Evidence for comparator
    		 NA
    Actual start date of recruitment
    05 Sep 2016
    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
    Italy: 99
    Worldwide total number of subjects
    99
    EEA total number of subjects
    99
    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)
    80
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First Patient First Visit: 05-09-2016; Last Patient First Visit: 27-03-2018; Last Patient Last Visit: 17-10-2018 The trial was conducted on 5 Sites: Site 01 - Salerno; Site 02 - Bologna; Site 03- Catanzaro; Site 04- Pisa; Site 05- Torino.

    Pre-assignment
    Screening details
    		 14 subjects did not meet the Inclusion/Exclusion Criteria.

    Pre-assignment period milestones
    Number of subjects started
    		 99
    Number of subjects completed
    		 99

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A PP
    Arm description
    		 Subjects treated with Olevia
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olevia 1000 mg
    Investigational medicinal product code
    042639029
    Other name
    OMEGAIBSA2
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    2000 mg/die for the first 2 months (2 capsule); 1000 mg/die for the third month (1 capsule).

    Arm title
    		 Arm B PP
    Arm description
    		 Subjects treated with placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    2000 mg/die for the first 2 months (2 capsule); 1000 mg/die for the third month (1 capsule).

    Number of subjects in period 1
    		Arm A PP Arm B PP
    Started
    49
    50
    Completed
    39
    41
    Not completed
    10
    9
         Lost to Follow up
    3
    3
         Physician decision
    1
    3
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    5
    -
         Lack of compliance
    -
    1
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A PP
    Reporting group description
    		 Subjects treated with Olevia

    Reporting group title
    Arm B PP
    Reporting group description
    		 Subjects treated with placebo

    Reporting group values
    		 Arm A PP Arm B PP Total
    Number of subjects
    		 49 50 99
    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)
    		 41 42 83
        From 65-84 years
    		 8 8 16
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 20 17 37
        Male
    		 29 33 62
    Subject analysis sets

    Subject analysis set title
    Arm A ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects with at least one efficay parameter assessment.

    Subject analysis set title
    Arm B ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects with at least one efficacy parameter assessment.

    Subject analysis set title
    Arm A PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects completed the study according to Protocol

    Subject analysis set title
    Arm B PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects completed the study according to Protocol

    Subject analysis sets values
    		 Arm A ITT Arm B ITT Arm A PP Arm B PP
    Number of subjects
    45
    45
    39
    41
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
        Adults (18-64 years)
    37
    37
    31
    34
        From 65-84 years
    8
    8
    8
    7
        85 years and over
    0
    0
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    18
    14
    16
    12
        Male
    27
    31
    23
    29

    End points

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    End points reporting groups
    Reporting group title
    Arm A PP
    Reporting group description
    		 Subjects treated with Olevia

    Reporting group title
    Arm B PP
    Reporting group description
    		 Subjects treated with placebo

    Subject analysis set title
    Arm A ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects with at least one efficay parameter assessment.

    Subject analysis set title
    Arm B ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects with at least one efficacy parameter assessment.

    Subject analysis set title
    Arm A PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects completed the study according to Protocol

    Subject analysis set title
    Arm B PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects completed the study according to Protocol

    Primary: Evaluation of the level of reduction of the primary tinnitus, through THI scale, in both groups.

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    End point title
    		 Evaluation of the level of reduction of the primary tinnitus, through THI scale, in both groups.
    End point description
    End point type
    Primary
    End point timeframe
    2 months and 3 months after baseline visit.
    End point values
    		 Arm A PP Arm B PP Arm A ITT Arm B ITT
    Number of subjects analysed
    39
    41
    45
    45
    Units: THI
    24
    22
    27
    24
    Statistical analysis title
    		 Evaluation of reduction in scale THI (PP)
    Statistical analysis description
    Subjects reduction in scale THI (PP)
    Comparison groups
    Arm B PP v Arm A PP
    Number of subjects included in analysis
    80
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.506 [2]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [1] - Two tailed test, alpha error = 0.05
    [2] - p=0.506 at 3 months. Both tests are not statisticaly significant
    Statistical analysis title
    		 Evaluation of reduction in scale THI (ITT)
    Statistical analysis description
    Subjects reduction in scale THI (ITT)
    Comparison groups
    Arm A ITT v Arm B ITT
    Number of subjects included in analysis
    90
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority [3]
    P-value
    		 = 0.671 [4]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [3] - Two tailed test, alpha error = 0.05
    [4] - p=0.657 at 3 months. Both tests are not statisticaly signinficant

    Secondary: Evaluation of level of compliance to treatment through, in both groups.

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    End point title
    		 Evaluation of level of compliance to treatment through, in both groups.
    End point description
    End point type
    Secondary
    End point timeframe
    2 months and 3 months after baseline visit
    End point values
    		 Arm A PP Arm B PP Arm A ITT Arm B ITT
    Number of subjects analysed
    39
    41
    45
    45
    Units: questionnary
    39
    40
    43
    44
    Statistical analysis title
    		 evaluation of compliance between groups pp
    Statistical analysis description
    evaluation of subject completing compliance
    Comparison groups
    Arm B PP v Arm A PP
    Number of subjects included in analysis
    80
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority [5]
    P-value
    		 = 1 [6]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [5] - Two tailed test, alpha error = 0.05
    [6] - p value =1 at three months both test are not staistical significant
    Statistical analysis title
    		 evaluation of compliance between groups ITT
    Comparison groups
    Arm A ITT v Arm B ITT
    Number of subjects included in analysis
    90
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority [7]
    P-value
    		 = 1 [8]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [7] - Two tailed test, alpha error = 0.05
    [8] - p value =1 at three months both test are not statistical significant

    Secondary: Evaluation of the grade of reduction of hyperacusis.

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    End point title
    		 Evaluation of the grade of reduction of hyperacusis.
    End point description
    End point type
    Secondary
    End point timeframe
    2 months and 3 months after baseline visit
    End point values
    		 Arm A PP Arm B PP Arm A ITT Arm B ITT
    Number of subjects analysed
    39
    41
    45
    45
    Units: questionnaire
    14
    19
    18
    20
    Statistical analysis title
    		 Reduction in Khalfa questionnaire (PP)
    Statistical analysis description
    Number of subjects reduction in Khalfa questionnaire (PP)
    Comparison groups
    Arm A PP v Arm B PP
    Number of subjects included in analysis
    80
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority [9]
    P-value
    		 = 0.372 [10]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [9] - Two tailed test, alpha error=0.05
    [10] - P=0.187 at 3 months. Both tests are not statisticaly significant
    Statistical analysis title
    		 Reduction in Khalfa questionnaire (ITT)
    Statistical analysis description
    Number of subjects reduction in Khalfa questionnaire (ITT)
    Comparison groups
    Arm A ITT v Arm B ITT
    Number of subjects included in analysis
    90
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority [11]
    P-value
    		 = 0.831 [12]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [11] - Two tailed test, alpha error=0.05
    [12] - p=0.191 at 3 months. Both tests are not statisticaly significant

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During all the study, from signature ICF to end of study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    Olevia
    Reporting group description
    		 Subjects treated by Olevia.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects treated by Placebo

    Serious adverse events
    		 Olevia Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 51 (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
    		 Olevia Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 49 (20.41%)
    3 / 51 (5.88%)
    Investigations
    Hypertransaminasaemia
    Additional description: MedDRA Cod. 10054889
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Hypercholesterolaemia
    Additional description: MedDRA Cod. 10020603
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 51 (1.96%)
         occurrences all number
    1
    1
    Injury, poisoning and procedural complications
    Subcutaneous haematoma
    Additional description: MedDRA Cod. 10022117.
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Hypotension
    Additional description: MedDRA Cod. 10021106
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Paraesthesia
    Additional description: MedDRA Cod. 10033987
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Tinnitus
    Additional description: MedDRA Cod. 10048029
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain upper
    Additional description: MedDRA Cod. 10064906
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Constipation
    Additional description: MedDRA Cod. 10010774
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Erythema
    Additional description: MedDRA Cod. 10015150
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Headache
    Additional description: MedDRA Cod. 10028411
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hypertriglyceridaemia
    Additional description: MedDRA Cod. 10020870
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 51 (3.92%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Feb 2016
    1) Background rational extension. 2) Added Follow Up Visit (Visit V4) 6 months after Baseline Visit. 3) At Drop Out section was added "Not compliance to treatment".

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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