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    Clinical Trial Results:
    Safety of intravesical bladder instillations among patients with severe interstitial cystitis

    Summary
    EudraCT number
    		 2015-004495-30
    Trial protocol
    		 FI  
    Global end of trial date
    02 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Nov 2024
    First version publication date
    20 Nov 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CYCLOIC-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Oulu University Hospital
    Sponsor organisation address
    Kajaanintie 50, Oulu, Finland,
    Public contact
    Urologian avohoitoyksikkö, Oulu University Hospital, markku.h.vaarala@ppshp.fi
    Scientific contact
    Urologian avohoitoyksikkö, Oulu University Hospital, markku.h.vaarala@ppshp.fi
    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
    02 Oct 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Oct 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Oct 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Safety of intravesical cyclosporine among patients with severe interstitial cystitis/painful bladder syndrome.
    Protection of trial subjects
    Regular follow up.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 4
    Worldwide total number of subjects
    4
    EEA total number of subjects
    4
    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)
    4
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study subjects were recruited from the patients of the sponsor.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 4
    Number of subjects completed
    		 4

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 cyclosporine
    Arm description
    		 Experimental arm
    Arm type
    		 Experimental

    Investigational medicinal product name
    cyclosporine
    Investigational medicinal product code
    L04AD01
    Other name
    Pharmaceutical forms
    Bladder irrigation
    Routes of administration
    Instillation
    Dosage and administration details
    Intravesical dose of 100 mg on day 1 and day 3. 200 mg on day 8 and day 10. 400 mg on day 15 and 17. 800 mg on day 22 and 24. The dose was reduced when needed.

    Number of subjects in period 1
    		cyclosporine
    Started
    4
    Completed
    4

    Baseline characteristics

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

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 4 4
    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))
    		 58 (52 to 64) -
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 3 3
    Subject analysis sets

    Subject analysis set title
    Cyclosporine dose
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Greatest tolerated cyclosporine dose

    Subject analysis set title
    Cyclosporine concentration
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Cyclosporine concentrations in blood

    Subject analysis sets values
    		 Cyclosporine dose Cyclosporine concentration
    Number of subjects
    4
    4
    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))
    58 (52 to 64)
    58 (52 to 64)
    Gender categorical
    Units: Subjects
        Female
    1
    1
        Male
    3
    3

    End points

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    End points reporting groups
    Reporting group title
    cyclosporine
    Reporting group description
    		 Experimental arm

    Subject analysis set title
    Cyclosporine dose
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Greatest tolerated cyclosporine dose

    Subject analysis set title
    Cyclosporine concentration
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Cyclosporine concentrations in blood

    Primary: Greatest tolerated cyclosporine dose

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    End point title
    		 Greatest tolerated cyclosporine dose [1]
    End point description
    End point type
    Primary
    End point timeframe
    0 to 30 days.
    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: Only four subjects enrolled, so no statistical analyses were performed.
    End point values
    		 Cyclosporine dose
    Number of subjects analysed
    4
    Units: milligram(s)/dose
        number (not applicable)
    800
    Attachments
    		 Doses
    No statistical analyses for this end point

    Secondary: Cyclosporine concentrations in blood

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    End point title
    		 Cyclosporine concentrations in blood
    End point description
    End point type
    Secondary
    End point timeframe
    0-30 days.
    End point values
    		 Cyclosporine concentration
    Number of subjects analysed
    4
    Units: microgram(s)/litre
        number (not applicable)
    29
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    0 days- 30 days.
    Adverse event reporting additional description
    Collected at the study visits.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI-CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 4 (100.00%)
    Cardiac disorders
    Hypertension
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Renal and urinary disorders
    Bladder pain
         subjects affected / exposed
    4 / 4 (100.00%)
         occurrences all number
    4
    Infections and infestations
    Cough
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1
    Upper aerodigestive tract infection
         subjects affected / exposed
    1 / 4 (25.00%)
         occurrences all number
    1

    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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