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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:
    Treprostinil Iontophoresis : a Pharmacodynamic and Pharmacokinetic Study

    Summary
    EudraCT number
    		 2011-003401-21
    Trial protocol
    		 FR  
    Global end of trial date
    31 Aug 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jun 2022
    First version publication date
    25 Jun 2022
    Other versions
    Summary report(s)
    		 Tipps (2011-003401-21) - results

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    11PHR02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01554540
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHUGA
    Sponsor organisation address
    CS10217, GRENOBLE, France,
    Public contact
    M.Roustit, CIC, mroustit@chu-grenoble.fr
    Scientific contact
    M.Roustit, DCIC, mroustit@chu-grenoble.fr
    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
    26 Jul 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Jan 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Aug 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Déterminer l’effet pharmacodynamique du tréprostinil administré par iontophorèse cutanée chez le volontaire sain, au niveau de la pulpe des doigts.
    Protection of trial subjects
    projet ayant reçu l'avis favorable d'un comité de protection des personnes / favorable advice of IRB in France
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jan 2012
    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
    France: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    57
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Critères d'inclusion: Volontaires sains : Première partie - Age de 18 ans au moins - Personne affilié à la sécurité sociale ou bénéficiaire d’un tel régime - Formulaire de consentement signé Patients : Seconde partie - Age de 18 ans au moins - Personne affilié à la sécurité sociale ou bénéficiaire d’un tel régime - Formulaire de consentem

    Period 1
    Period 1 title
    Study period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 treprostinil
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    tteprostinil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Transdermal solution
    Routes of administration
    Iontophoresis
    Dosage and administration details
    different dosage

    Number of subjects in period 1
    		treprostinil
    Started
    60
    Completed
    60
    Period 2
    Period 2 title
    NaCL
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 NaCL
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    NaCL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Transdermal solution
    Routes of administration
    Iontophoresis
    Dosage and administration details
    2,56.10-4 M

    Number of subjects in period 2
    		NaCL
    Started
    60
    Completed
    60

    Baseline characteristics

    		 Close Top of page

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    treprostinil
    Reporting group description
    		 -
    Reporting group title
    NaCL
    Reporting group description
    		 -

    Primary: primary

    		 Close Top of page
    End point title
    		 primary
    End point description
    End point type
    Primary
    End point timeframe
    Aire sous la courbe de l’augmentation de flux cutané 10 heures (AUC0-10) après iontophorèse de tréprostinil (2,56.10-4 M ; 20 min jusqu’à 0,1mA.cm-2) évaluée en imagerie laser speckle, comparée à l’iontophorèse de chlorure de sodium (NaCl).
    End point values
    		 treprostinil NaCL
    Number of subjects analysed
    60
    60
    Units: AUC
        number (not applicable)
    23066.1
    11187.1
    Statistical analysis title
    		 primary end point
    Statistical analysis description
    L’amplitude de la réponse à l’iontophorèse de tréprostinil en aire sous la courbe (AUC0-10) sera comparée celle de NaCl par un test de t apparié si les données suivent une loi normale. Un test de Wilcoxon sera réalisé dans le cas contraire. Les tests seront réalisés après correction de Bonferroni pour comparaisons multiples
    Comparison groups
    treprostinil v NaCL
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 AUC
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Les effets indésirables graves seront notifiés jusqu’à 7 jours après la dernière visite au cours de laquelle une administration de tréprostinil aura été effectuée
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Treprostinil + NaCl
    Reporting group description
    		 -

    Serious adverse events
    		 Treprostinil + NaCl
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 60 (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
    		 Treprostinil + NaCl
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 60 (20.00%)
    Skin and subcutaneous tissue disorders
    dermabrasion
         subjects affected / exposed
    12 / 60 (20.00%)
         occurrences all number
    23

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 May 2015
    La modification envisagée est la suivante : - réaliser une étude ancillaire sur 12 volontaires sains supplémentaires à la concentration de 1mg/ml au lieu de 0.1 mg/ml. - Mise à jour du RCP Remodulin - Modification de la date de fin de l’étude : janvier 2016 - Durée de l’étude par sujet (42 jours) - Mise à jour des coordonnées vigilance

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri May 03 11:17:55 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA