Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   38482   clinical trials with a EudraCT protocol, of which   6323   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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%)
    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
    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

    More information

    Close Top of page

    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
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA