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    Clinical Trial Results:
    EFFECTS OF TWO DIFFERENT DOSES OF REC 0/0438 ADMINISTERED BY INTRA-VESICAL INSTILLATION IN PATIENTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY: A REPEATED DOSES, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY

    Summary
    EudraCT number
    		 2017-000905-19
    Trial protocol
    		 PT   PL   CZ   FR  
    Global end of trial date
    27 Mar 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Dec 2020
    First version publication date
    10 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    REC 0/0438-IT-CL 0491
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03482037
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Recordati SPA
    Sponsor organisation address
    Via Civitali, 1, Milan, Italy, 20148
    Public contact
    Senior Clinical Project Leader, Recordati S.p.A, 0039 02487871, casi.m@recordati.it
    Scientific contact
    Senior Clinical Project Leader, Recordati S.p.A, 0039 02487871, casi.m@recordati.it
    Sponsor organisation name
    Recordati SPA
    Sponsor organisation address
    Via Civitali, 1, Milan, Italy, 20148
    Public contact
    Massimo Casi, MD, Medical Department, Recordati SPA, casi.m@recordati.it
    Scientific contact
    Massimo Casi, MD, Medical Department, Recordati SPA, casi.m@recordati.it
    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
    13 Mar 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Mar 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Mar 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to investigate the safety and tolerability of repeated doses of Rec 0/0438 administered by intravesical instillation for four weeks in subjects suffering from NDO
    Protection of trial subjects
    Cystometry: the procedure has been performed only by qualified and experienced operators according to international good practice guidelines and the subjects' health status has been monitored. Blood tests: the quantity of blood taken for testing did not constitute a danger for the subjects' health.
    Background therapy
    		 The use of placebo was considered acceptable in this study since it was administered on top of current treatment (antimuscarinic drugs).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Jun 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 37
    Country: Number of subjects enrolled
    Portugal: 2
    Country: Number of subjects enrolled
    Czechia: 2
    Country: Number of subjects enrolled
    France: 1
    Worldwide total number of subjects
    42
    EEA total number of subjects
    42
    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)
    42
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 FPI: 07 June 2018 LPLV: 27 March 2019

    Pre-assignment
    Screening details
    		 Male or female patients aged between 18 and 65 years and suffering from NDO due to SCI at upper motor neuron level (below C6) and emptying the bladder performing clear intermittent self-catheterisation (CISC) with at least 1 incontinence episode/day, reported in the bladder diary, despite current treatment.

    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, Monitor, Data analyst, Carer
    Blinding implementation details
    The patients, the Investigators, the Sponsor and the statistician were kept blind. DSMC received blinded data for its analysis. The study personnel were fully blinded throughout the study and remained so until unblinding after database lock. Measures were taken to ensure that test drug/investigational product and placebo were indistinguishable in regard to appearance, shape, smell, and taste of the test material.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 REC 0/0438 1 mg
    Arm description
    		 REC 0/0438 1 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    REC 0/0438 1 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for intravesical solution
    Routes of administration
    Intravesical use
    Dosage and administration details
    REC 0/0438 1 mg oad. The study drug was administered after voiding of the bladder at the end of the first self-catheterisation of the day

    Arm title
    		 REC 0/0438 2 mg
    Arm description
    		 REC 0/0438 2 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    REC 0/0438 2 mg
    Investigational medicinal product code
    REC 0/0438 2 mg
    Other name
    Pharmaceutical forms
    Powder for intravesical solution
    Routes of administration
    Intravesical use
    Dosage and administration details
    REC 0/0438 2 mg oad. The study drug was administered after voiding of the bladder at the end of the first self-catheterisation of the day

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for intravesical solution
    Routes of administration
    Intravesical use
    Dosage and administration details
    Placebo oad. The study drug was administered after voiding of the bladder at the end of the first self-catheterisation of the day

    Number of subjects in period 1
    		REC 0/0438 1 mg REC 0/0438 2 mg Placebo
    Started
    14
    13
    15
    Completed
    14
    13
    13
    Not completed
    0
    0
    2
         Consent withdrawn by subject
    -
    -
    1
         Adverse event, non-fatal
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 42 42
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 42 42
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.3 ± 10.5 -
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 36 36

    End points

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    End points reporting groups
    Reporting group title
    REC 0/0438 1 mg
    Reporting group description
    		 REC 0/0438 1 mg

    Reporting group title
    REC 0/0438 2 mg
    Reporting group description
    		 REC 0/0438 2 mg

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Primary: Safety and Tolerability

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    End point title
    		 Safety and Tolerability [1]
    End point description
    End point type
    Primary
    End point timeframe
    From Baseline to End of study treatment
    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: Due to the exploratory nature of the study and the small sample size, the safety data have been evaluated by means of descriptive statistics only and summarised by treatment group.
    End point values
    		 REC 0/0438 1 mg REC 0/0438 2 mg Placebo
    Number of subjects analysed
    14
    13
    15
    Units: Treatment Emergent AEs
        number (not applicable)
    7
    4
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline to end of study treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    REC 0/0438 1 mg
    Reporting group description
    		 -

    Reporting group title
    REC 0/0438 2 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 REC 0/0438 1 mg REC 0/0438 2 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 REC 0/0438 1 mg REC 0/0438 2 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 14 (28.57%)
    4 / 13 (30.77%)
    5 / 15 (33.33%)
    Investigations
    Body temperature increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Vascular disorders
    Emathoma
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Extrasystoles
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Reproductive system and breast disorders
    Orchitis noninfective
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    2
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Muscle spasms
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Viral pharyngitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary tract infection
         subjects affected / exposed
    2 / 14 (14.29%)
    3 / 13 (23.08%)
    4 / 15 (26.67%)
         occurrences all number
    2
    3
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

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