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    Clinical Trial Results:
    A Phase III multicenter, double-blind, placebo-controlled, study evaluating the safety, and efficacy of STR001 treatment (intratympanic injection + tablets) in adults with Sudden Sensorineural Hearing Loss

    Summary
    EudraCT number
    2017-000242-22
    Trial protocol
    DE   CZ   PL  
    Global end of trial date
    06 Feb 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    10 Sep 2020
    First version publication date
    10 Sep 2020
    Other versions
    Summary report(s)
    STR001-202_Statistical Analysis of Efficacy of Primary and Key Secondary Endpoints

    Trial information

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    Trial identification
    Sponsor protocol code
    STR001-202
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Strekin AG
    Sponsor organisation address
    Hochbergerstrasse 60C, Basel, Switzerland, 4057
    Public contact
    Alexander Bausch, PhD CEO, Strekin AG, +41 797888252, alexander.bausch@strekin.com
    Scientific contact
    Viktor Boerlin, MD Chief Medical Officer, Strekin AG, +41 791267335, viktor.boerlin@strekin.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
    27 Jul 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Feb 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Feb 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study are: - To evaluate the safety and tolerability of intratympanic administration of STR001-IT thermogel followed by oral treatment with STR001-ER in patients with Sudden Sensorineural Hearing Loss - To assess the efficacy of intratympanic administration of STR001-IT thermogel followed by oral treatment with STR001-ER in measuring hearing improvement at week 12 by PTA measurement at the 3 most contiguous affected frequencies seen at baseline
    Protection of trial subjects
    Study reviewed by independent ethics committees in all countries according to regulations. Subjects were treated within the usual settings in participating sites or were referred to them by practising ENT physicians.
    Background therapy
    All patients received the local standard of care for sudden sensorineural hearing loss, including a corticosteroid preparation.
    Evidence for comparator
    The comparison for STR001 intratympanic injection and STR001 tablets were placebo formulations. No generally approved drug for the treatment of sudden sensorineural hearing loss is available.
    Actual start date of recruitment
    01 Jun 2017
    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: 18
    Country: Number of subjects enrolled
    Czech Republic: 18
    Country: Number of subjects enrolled
    Germany: 29
    Country: Number of subjects enrolled
    Russian Federation: 84
    Country: Number of subjects enrolled
    Switzerland: 16
    Worldwide total number of subjects
    165
    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)
    126
    From 65 to 84 years
    39
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Recruitment period: 01-06-2017 to 06-12-2019 in 5 countries: Czech Republic, Germany, Poland, Russian Federation and Switzerland. First patient randomized on 24-10-2017.

    Pre-assignment
    Screening details
    Patients were recruited when they had noticed severe sudden hearing loss and contacted one of the participating sites or were referred to them by a ear-nose-throat doctor in practice. The patients had an audiogram and when the diagnosis of severe or profound sudden sensorineural hearing loss was confirmed, they were candidates for the study

    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
    Investigator, Monitor, Data analyst, Carer, Assessor, Subject
    Blinding implementation details
    Since active and placebo suspension in the ampoules did not have exactly the same appearance, the syringe was prepared by an independent study site person and handed with a cover to the injecting investigator. The active and placebo tablets were of identical appearance and were distributed to the patients in bottles.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    STR-5: Active Treatment
    Arm description
    Patients randomized to Arm 1 received an intratympanic injection of STR001 at Day 1 and underwent a 3-month oral treatment with STR001 tablets
    Arm type
    Experimental

    Investigational medicinal product name
    STR001 thermogel and STR001-ER (tablets)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion, Tablet
    Routes of administration
    Auricular use, Oral use
    Dosage and administration details
    On Day 1 all patients in Arm1 received an intratympanic injection of STR001 thermogel. For the following three months the patients were provided with STR001 tablets containing 5 mg of pioglitazone once daily.

    Arm title
    STR-0: STR001 intratympanic injection + placebo tablets
    Arm description
    Patients in Arm 2 received an intratympanic injection of STR001 at Day1, For the following three months they received one placebo tablet per day.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo tablets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All patients received at Day 1 an intratympanal injection of STR001. For the following three months they received one tablet of placebo per day.

    Arm title
    Placebo
    Arm description
    Patients in Arm 3 received an intratympanic injection of placebo at Day 1 and for the following three months a placebo tablet per day.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo injection solution and placebo tablets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection, Tablet
    Routes of administration
    Intratympanic use , Oral use
    Dosage and administration details
    On Day 1 all patients in Arm3 received an intratympanic injection of placebo thermogel. For the following three months the patients were provided with placebo tablets once daily.

    Number of subjects in period 1
    STR-5: Active Treatment STR-0: STR001 intratympanic injection + placebo tablets Placebo
    Started
    56
    56
    53
    Completed
    50
    52
    50
    Not completed
    6
    4
    3
         Consent withdrawn by subject
    3
    1
    2
         Subject not dosed
    -
    -
    1
         Adverse event, non-fatal
    -
    1
    -
         patient randomized but not dosed
    1
    -
    -
         Lost to follow-up
    2
    1
    -
         Physician's decision
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    STR-5: Active Treatment
    Reporting group description
    Patients randomized to Arm 1 received an intratympanic injection of STR001 at Day 1 and underwent a 3-month oral treatment with STR001 tablets

    Reporting group title
    STR-0: STR001 intratympanic injection + placebo tablets
    Reporting group description
    Patients in Arm 2 received an intratympanic injection of STR001 at Day1, For the following three months they received one placebo tablet per day.

    Reporting group title
    Placebo
    Reporting group description
    Patients in Arm 3 received an intratympanic injection of placebo at Day 1 and for the following three months a placebo tablet per day.

    Reporting group values
    STR-5: Active Treatment STR-0: STR001 intratympanic injection + placebo tablets Placebo Total
    Number of subjects
    56 56 53 165
    Age categorical
    Subjects enrolled per age group
    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)
    43 44 42 129
        From 65-84 years
    13 12 11 36
        85 years and over
    0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    30 32 31 93
        Male
    26 24 22 72
    Subject analysis sets

    Subject analysis set title
    Intention-to-treat
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Includes all randomized patients

    Subject analysis set title
    Safety Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Includes patients who have received at least one dose of study drug.

    Subject analysis set title
    Per Protocol Set
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Patients who completed the trial according to the protocol without major protocol violations influencing the efficacy results.

    Subject analysis sets values
    Intention-to-treat Safety Set Per Protocol Set
    Number of subjects
    165
    162
    134
    Age categorical
    Subjects enrolled per age group
    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)
    129
    124
    104
        From 65-84 years
    36
    38
    30
        85 years and over
    0
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    93
    83
    70
        Male
    72
    79
    64

    End points

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    End points reporting groups
    Reporting group title
    STR-5: Active Treatment
    Reporting group description
    Patients randomized to Arm 1 received an intratympanic injection of STR001 at Day 1 and underwent a 3-month oral treatment with STR001 tablets

    Reporting group title
    STR-0: STR001 intratympanic injection + placebo tablets
    Reporting group description
    Patients in Arm 2 received an intratympanic injection of STR001 at Day1, For the following three months they received one placebo tablet per day.

    Reporting group title
    Placebo
    Reporting group description
    Patients in Arm 3 received an intratympanic injection of placebo at Day 1 and for the following three months a placebo tablet per day.

    Subject analysis set title
    Intention-to-treat
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Includes all randomized patients

    Subject analysis set title
    Safety Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Includes patients who have received at least one dose of study drug.

    Subject analysis set title
    Per Protocol Set
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Patients who completed the trial according to the protocol without major protocol violations influencing the efficacy results.

    Primary: Absolute hearing improvement using average pure tone audiogram thresholds

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    End point title
    Absolute hearing improvement using average pure tone audiogram thresholds [1]
    End point description
    Improvement of absolute hearing measured as the average of the three most affected contiguous frequencies using pure tone audiometry.
    End point type
    Primary
    End point timeframe
    Baseline to Week 12
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The statistical analysis was planned in two steps: firstly the comparison of STR-5 and placebo for the endpoints, secondly the comparison of STR-0 and placebo. Details are in the attachment
    End point values
    STR-5: Active Treatment STR-0: STR001 intratympanic injection + placebo tablets Placebo Intention-to-treat
    Number of subjects analysed
    53
    53
    50
    156
    Units: dB
        arithmetic mean (standard deviation)
    45 ± 21
    40 ± 17
    44 ± 18
    43 ± 19
    No statistical analyses for this end point

    Secondary: Improvement of speech recognition at 60 dB

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    End point title
    Improvement of speech recognition at 60 dB
    End point description
    Improvement in the percentage of 20 words in local language at 60dB understood
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 12
    End point values
    STR-5: Active Treatment STR-0: STR001 intratympanic injection + placebo tablets Placebo Intention-to-treat
    Number of subjects analysed
    51
    50
    50
    151
    Units: words understood
    38
    40
    40
    39
    No statistical analyses for this end point

    Secondary: Improvement in speech recognition at 80 dB

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    End point title
    Improvement in speech recognition at 80 dB
    End point description
    Improvement in the percentage of words out of 20 in local language understood at 80 dB
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    STR-5: Active Treatment STR-0: STR001 intratympanic injection + placebo tablets Placebo Intention-to-treat
    Number of subjects analysed
    50
    51
    50
    151
    Units: words understood
    29
    28
    28
    28
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Patients were followed for 24 Weeks after randomization. After Week 12, the patients did not receive any study medication.
    Adverse event reporting additional description
    Advere events were collected from patient reporting, physical findings and laboratory results.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    STR-5
    Reporting group description
    See description in the results section: STR001 intratympanic injection at Day1 followed by three months oral tablet treatment with 5 mg of STR001.

    Reporting group title
    STR-0
    Reporting group description
    Patients in this treatment group received at Day 1 an intratympanic injection of STR001, followed by three months once daily intake of a placebo tablet.

    Reporting group title
    Placebo
    Reporting group description
    Patients received at Day 1 an intratympanic injection of placebo followed by a three months oral administration of placebo tablets once daily.

    Serious adverse events
    STR-5 STR-0 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 56 (0.00%)
    0 / 52 (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
    STR-5 STR-0 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 54 (27.78%)
    21 / 56 (37.50%)
    15 / 52 (28.85%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 54 (3.70%)
    7 / 56 (12.50%)
    2 / 52 (3.85%)
         occurrences all number
    2
    7
    2
    Headache
         subjects affected / exposed
    6 / 54 (11.11%)
    1 / 56 (1.79%)
    6 / 52 (11.54%)
         occurrences all number
    6
    1
    6
    Ear and labyrinth disorders
    Tinnitus
    Additional description: Tinnitus can be a symptom of sudden sensorineural hearing loss. Whether tinnitus was caused by the disease to study or the study drug cannot be determined.3
         subjects affected / exposed
    3 / 54 (5.56%)
    7 / 56 (12.50%)
    1 / 52 (1.92%)
         occurrences all number
    3
    7
    1
    Vertigo
    Additional description: Vertigo may be a symptom of sudden sensorineural hearing loss. Whether patients' vertigo was caused by administration of the study drug or by the disease to study could not be determined.
         subjects affected / exposed
    1 / 54 (1.85%)
    5 / 56 (8.93%)
    4 / 52 (7.69%)
         occurrences all number
    1
    6
    4
    Infections and infestations
    Viral upper respiratory tract infection
         subjects affected / exposed
    3 / 54 (5.56%)
    1 / 56 (1.79%)
    2 / 52 (3.85%)
         occurrences all number
    3
    1
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Feb 2018
    Amendment 1 - substantial - Change and clearer description of secondary study objectives - Increase in severity of hearing loss from average pure tone audiometric threshold from 60 dB to 75 dB. Change in inclusion criterion 4. - Removal of exclusion criterion 2: no upper limit of hearing threshold defined. - Change in exclusion criterion 5: definition of air-bone gap in the most affected frequencies at baseline. - Amendment of protective measures for contraception - Change in storage condition requirement for study drug tablets - Addition of hyperbaric oxygen therapy among the prohibited treatments during study - Restriction of time frame to one month prior baseline for capturing medications in the eCRF - Change for guidance in microscopic urinalysis (only if positive findings with dipstick) - Reduction of blood safety parameters to be analysed - Change in BCTA frequency assessment - Plan for blinded interim analysis (not conducted eventually) - Minor change in schedule of assessments
    05 Jul 2019
    Amendment 2 - considered administrative amendment Change affected the timepoint of a blinded interim analysis for the primary endpoint. It was moved to the time when all patients had reached the Week 12 visit and terminated study treaments. This analysis was performed by an independent statistician and the study team were kept blinded with regard to individual data.

    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.
    The template did not allow to enter the statistical analyses data. Therefore they will be supplied by a summary attachment of the statistical analyses for the primary and the key secondary endpoint.
    For support, Contact us.
    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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