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    Clinical Trial Results:
    Phase III, randomized, open-label, multicenter evaluation of efficacy and tolerability of Ialuril (sodium hyaluronate-chondroitin sulfate) vs. dimethyl sulfoxide (DMSO) in women with interstitial cystitis / painful bladder syndrome (IC / BPS)

    Summary
    EudraCT number
    		 2010-021556-25
    Trial protocol
    		 IT  
    Global end of trial date
    30 Sep 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Mar 2019
    First version publication date
    21 Mar 2019
    Other versions
    Summary report(s)
    		 cervigni-2016

    Trial information

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    Trial identification
    Sponsor protocol code
    IBSA 01-2010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IBSA Institut Biochimique SA
    Sponsor organisation address
    Via del Piano 29, Pambio-Noranco, Switzerland, 6915
    Public contact
    Valeria Frangione, IBSA Institut Biochimique SA, +41 583601000, valeria.frangione@ibsa.ch
    Scientific contact
    Valeria Frangione, IBSA Institut Biochimique SA, valeria.frangione@ibsa.ch
    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
    08 Jan 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Sep 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study was the assessment of the efficacy of Ialuril as compared to DMSO (RIMSO-50) in patients suffering from BPS/IC
    Protection of trial subjects
    No other intravesical drug was allowed throughout the study, either during the treatment or during the follow-up period. No other restrictions in prior or concomitant therapy were considered in the protocol.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jun 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 3 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 110
    Worldwide total number of subjects
    110
    EEA total number of subjects
    110
    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)
    91
    From 65 to 84 years
    18
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Italy FPFV: 30-Jun-2011 LPLV: 30-Sep-2013

    Pre-assignment
    Screening details
    		 110 female patients older than 18 with diagnosis of BPS/IC were screened

    Period 1
    Period 1 title
    Study Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ialuril
    Arm description
    		 intravesical instillation every 7 days for a total of 13 instillations over 3 months + 3 months of follow-up without treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ialuril
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Intravesical solution
    Routes of administration
    Intravesical use
    Dosage and administration details
    intravesical instillation every 7 days for a total of 13 instillations over 3 months

    Arm title
    		 DMSO
    Arm description
    		 intravesical instillation every 7 days for a total of 13 instillations over 3 months + 3 months of follow-up without treatment
    Arm type
    		 Active comparator

    Investigational medicinal product name
    RIMSO-50
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Intravesical solution
    Routes of administration
    Intravesical use
    Dosage and administration details
    one instillation every 7 days for a total of 13 instillations, over 3 months

    Number of subjects in period 1
    		Ialuril DMSO
    Started
    74
    36
    Completed
    59
    29
    Not completed
    15
    7
         Consent withdrawn by subject
    5
    3
         Adverse event, non-fatal
    1
    2
         Lost to follow-up
    6
    -
         Lack of efficacy
    2
    2
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ialuril
    Reporting group description
    		 intravesical instillation every 7 days for a total of 13 instillations over 3 months + 3 months of follow-up without treatment

    Reporting group title
    DMSO
    Reporting group description
    		 intravesical instillation every 7 days for a total of 13 instillations over 3 months + 3 months of follow-up without treatment

    Reporting group values
    		 Ialuril DMSO Total
    Number of subjects
    		 74 36 110
    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 (standard deviation)
    		 50.95 ( 14.97 ) 48.78 ( 17.70 ) -
    Gender categorical
    Units: Subjects
        Female
    		 74 36 110
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Ialuril
    Reporting group description
    		 intravesical instillation every 7 days for a total of 13 instillations over 3 months + 3 months of follow-up without treatment

    Reporting group title
    DMSO
    Reporting group description
    		 intravesical instillation every 7 days for a total of 13 instillations over 3 months + 3 months of follow-up without treatment

    Primary: VAS pain reduction

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    End point title
    		 VAS pain reduction
    End point description
    End point type
    Primary
    End point timeframe
    at 6 months (end of follow-up) versus baseline
    End point values
    		 Ialuril DMSO
    Number of subjects analysed
    74
    36
    Units: mm
        arithmetic mean (standard deviation)
    39.15 ( 29.14 )
    30.36 ( 30.53 )
    Statistical analysis title
    		 Primary Endpoint
    Statistical analysis description
    Difference Ialuril vs. RIMSO-50 in VAS pain reduction
    Comparison groups
    DMSO v Ialuril
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.111 [1]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [1] - between treatment groups

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The study was divided into 3 periods: screening (Visit 1), treatment (13 weekly visits), follow-up (Visit 15 after 3 months without any treatment). Adverse Events were evaluated at each visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Ialuril
    Reporting group description
    		 intravesical instillation every 7 days for a total of 13 instillations over 3 months + 3 months of follow-up without treatment

    Reporting group title
    DMSO
    Reporting group description
    		 intravesical instillation every 7 days for a total of 13 instillations over 3 months + 3 months of follow-up without treatment

    Serious adverse events
    		 Ialuril DMSO
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 36 (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
    		 Ialuril DMSO
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 74 (1.35%)
    8 / 36 (22.22%)
    Renal and urinary disorders
    Bladder pain
         subjects affected / exposed
    1 / 74 (1.35%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Bladder irritation
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Cystitis
         subjects affected / exposed
    0 / 74 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    4
    Dysuria
         subjects affected / exposed
    0 / 74 (0.00%)
    4 / 36 (11.11%)
         occurrences all number
    0
    4
    Strangury
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 36 (2.78%)
         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
    16 Jan 2012
    Urodynamic test, Cystourethroscopy and Vulvoscopy were considered as “Optional” at screening and during the study. Some inclusion criteria were better specified and, in particular: - criterion n. 2 was changed to reflect the ESSIC guideline nomenclature, as for what regards the disease under study (from “IC/PBS” to “BPS/IC”) - criterion n. 4 was changed to allow the recruitment of patients who are not sexually active.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27654012
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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
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