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    Clinical Trial Results:
    The effect of curcumin and genistein in CF patients with a class III mutation

    Summary
    EudraCT number
    		 2014-000817-30
    Trial protocol
    		 NL  
    Global end of trial date
    08 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Mar 2020
    First version publication date
    11 Mar 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TICTAC-2014
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UMC Utrecht
    Sponsor organisation address
    Lundlaan 6, Utrecht, Netherlands,
    Public contact
    Prof. dr. C.K. van der Ent, University Medical Center Utrecht, 0031 (0)887553201, k.vanderent@umcutrecht.nl
    Scientific contact
    Gitte Berkers, University Medical Center Utrecht, 0031 (0)887553741, g.berkers-3@umcutrecht.nl
    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
    01 Nov 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    08 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Curcumin and genistein might be a cheap alternative for treating patients with a class III gating mutation Main objective of the trial is to investigate the clinical response on treatment with curcumin and genistein in CF-patients with a class III S1251N mutation.
    Protection of trial subjects
    N.A.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Sep 2014
    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
    Netherlands: 13
    Worldwide total number of subjects
    13
    EEA total number of subjects
    13
    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)
    4
    Adolescents (12-17 years)
    4
    Adults (18-64 years)
    5
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 inclusion criteria: • CFTR genotype compound/ S1251N • Already had a rectal biopsy to produce an organoid • Male and female patients, aged 6 years or older on the date of informed consent or, where appropriate, date of assent • Signed informed consent form (IC), and where appropriate, signed assent form

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Treatment
    Arm description
    		 treatment with curcumin and genistein
    Arm type
    		 Experimental

    Investigational medicinal product name
    curcumin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    curcumin was dosed based on the weight of the patient with a minimum dose of 102.9 and maximum dose of 138.5 mg/Kg/day

    Investigational medicinal product name
    genistein
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Dose was based on weight with a minimum dose of 3.3 and a maximum dose of 4.8 mg/Kg/day

    Arm title
    		 baseline
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Treatment baseline
    Started
    13
    13
    Completed
    13
    13

    Baseline characteristics

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

    Reporting group values
    		 treatment period Total
    Number of subjects
    		 13 13
    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
        median (inter-quartile range (Q1-Q3))
    		 15.0 (10.0 to 33.0) -
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 8 8

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 treatment with curcumin and genistein

    Reporting group title
    baseline
    Reporting group description
    		 -

    Primary: Sweat chloride concentration

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    End point title
    		 Sweat chloride concentration
    End point description
    End point type
    Primary
    End point timeframe
    after 8 weeks of treatment
    End point values
    		 Treatment baseline
    Number of subjects analysed
    13
    13
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    76 (64 to 81)
    80.0 (65.5 to 91.0)
    Statistical analysis title
    		 Wilcoxon signed rank test
    Comparison groups
    baseline v Treatment
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Point estimate
    30
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18.28
         upper limit
    		 41.72
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first visit of the trial (t=0) untill the last visit (t= 8weeks)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NA
    Dictionary version
    0
    Reporting groups
    Reporting group title
    treatment period
    Reporting group description
    		 during treatment with curcumin and genistein

    Serious adverse events
    		 treatment period
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 treatment period
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 13 (92.31%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 13 (30.77%)
         occurrences all number
    5
    Vertigo
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Night sweats
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Gastrointestinal disorders
    Yellow stool
         subjects affected / exposed
    4 / 13 (30.77%)
         occurrences all number
    4
    Flatulence
         subjects affected / exposed
    3 / 13 (23.08%)
         occurrences all number
    3
    stomach ache
         subjects affected / exposed
    2 / 13 (15.38%)
         occurrences all number
    7
    diarrhea
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    throwing up
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    cough up more sputum
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jun 2014
    The effect of curcumin and genistein was evaluated but not compared to the effect of Ivacaftor treatment. This was done in a separate trial

    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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