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    Summary
    EudraCT Number:2014-003720-43
    Sponsor's Protocol Code Number:NIK-08-2014
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-10-03
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2014-003720-43
    A.3Full title of the trial
    "Prevention of nicotine abstinence in critically ill patients after major surgery"
    „Prevence nikotinové abstinence u kriticky nemocných pacientů po velkých chirurgických výkonech“
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention of nicotine abstinence symptoms in critically ill patients
    Prevence příznaků nikotinové abstinence u kriticky nemocných pacientů
    A.3.2Name or abbreviated title of the trial where available
    NIKOTIN
    NIKOTIN
    A.4.1Sponsor's protocol code numberNIK-08-2014
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFakultní nemocnice Ostrava
    B.1.3.4CountryCzech Republic
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFakultní nemocnice Ostrava
    B.4.2CountryCzech Republic
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFakultní nemocnice Ostrava
    B.5.2Functional name of contact pointEthical committee
    B.5.3 Address:
    B.5.3.1Street AddressTřída 17.listopadu 1790
    B.5.3.2Town/ cityOstrava
    B.5.3.3Post code70852
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number+420597372516
    B.5.5Fax number+420597372516
    B.5.6E-mailmartina.robenkova@fno.cz
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Niquitin Clear 21mg
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKlein
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Cutaneous patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeSyntetic medicinal product
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCutaneous patch
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Nicotin abstinence delirium
    Delirium nikotinové abstinence
    E.1.1.1Medical condition in easily understood language
    The risk of nicotine abstinence delirium development in critically ill patients
    Riziko deliria při nokotinové abstinenci u kriticky nemocných pacientů
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to determine whether the application of transdermal nicotine patches in critically ill patients after major surgery with nicotine abstinence condition is associated with a lower incidence of delirium.
    Primárním cílem této studie je zjistit, zda je aplikace transdermálních nikotinových náplastí u kriticky nemocných pacientů po velkém chirurgickém výkonu s předpokladem nikotinové abstinence spojena s nižším výskytem deliria.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to determine whether the application of transdermal nicotine patches in critically ill patients after major surgery with the assumption of nicotine abstinence is associated with shorter duration of mechanical ventilation in these patients.
    Sekundárním cílem této studie je zjistit, zda je aplikace nikotinových transdermálních náplastí u kriticky nemocných pacientů po velkém chirurgickém výkonu s předpokladem nikotinové abstinence spojena s kratší dobou umělé plicní ventilace těchto pacientů.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients older than 18 years.
    • Patients with the assumption of nicotine abstinence. Prerequisite sudden nicotine abstinence as a risk factor for development of delirium will be assessed by the Test for Nicotine Dependence according to the Fagerstrom. The questionnaire will be filled by the patient within medical examination before anesthesia.

    • Patients included in the group of patients undergoing major surgery within the abdominal region, urology and thoracic surgery and to subsequent ICU clinics KARIM FNO> 48 hours. Presumption of hospitalization in the ICU clinics KARIM FNO> 48 hours will be determined based on the prediction of the medical assessment.

    • Obtaining informed consent (signed and dated) approved MEK.
    • Pacienti starší 18 let.

    • Pacienti s předpokladem nikotinové abstinence. Předpoklad náhlé nikotinové abstinence jakožto rizikového faktoru vzniku deliria bude posuzován podle Testu nikotinové závislosti dle Fagerstroma. Dotazník bude vyplňován samotným pacientem v rámci předanestetického vyšetření.

    • Pacienti spadající do souboru nemocných podstupujících velký chirurgický výkon spadající do oblasti břišní, urologické a hrudní chirurgie a předpokladem následného pobytu na JIP kliniky KARIM FNO > 48 hod. Předpoklad hospitalizace na JIP kliniky KARIM FNO > 48 hod bude stanoven na základě predikce lékařského posouzení.

    • Získání informovaného souhlasu (podepsaného a datovaného) schváleného MEK.
    E.4Principal exclusion criteria
    • Age <18 years.
    • failure to obtain informed consent approved by the Ethics Committee.
    • Patients undergoing neurosurgical operation, patients diagnosed with cranial trauma.
    • Patients diagnosed with psychiatric illness.
    • Known allergy to nicotine or any other component of the transdermal patch NiQuitin CLEAR 21 mg.
    • Known allergy to surgical bandage Curapor.
    • patients with recent heart attack, unstable or worsening angina or patients with serious heart rhythm disorders, patients with a fresh stroke.
    • Pregnant and nursing women.
    • Patients with concomitant treatment with products containing nicotine.
    • Věk < 18 let.
    • Nezískání Informovaného souhlasu schváleného Etickou komisí.
    • Pacienti po neurochirurgickém výkonu, pacienti s diagnostikovaným kraniotraumatem.
    • Pacienti s diagnostikovaným psychiatrickým onemocněním.
    • Známá alergie na nikotin či jinou složku transdermální náplasti NIQUITIN CLEAR 21 mg.
    • Známá alergie na chirurgický obvaz Curapor.
    • Pacienti s čerstvým srdečním infarktem, nestabilní nebo zhoršující se anginou pectoris nebo pacienti se závažnými poruchami srdečního rytmu, pacienti s čerstvou mozkovou mrtvicí.
    • Těhotné a kojící ženy.
    • Pacienti se současnou léčbou přípravky obsahujícími nikotin.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint (primary endpoint) to achieve a statistically significant (significance level p ≤ 0.05) reduction in the incidence of delirium in the group of patients with the application of the study drug.
    Základním parametrem účinnosti (primární endpoint) je dosažení statisticky významné (hladina významnosti p ≤ 0,05) snížení incidence deliria ve skupině pacientů s aplikací studijního léčiva.
    E.5.1.1Timepoint(s) of evaluation of this end point
    When 100 patients complete study after 18 month.
    Po ukončení studie náborem 100 pacientů po uplynutí 18 měsíců
    E.5.2Secondary end point(s)
    The secondary efficacy parameter (secondary endopoint) to achieve a statistically significant (significance level p ≤ 0.05) reduction of the number of hours of mechanical ventilation in patients.
    Vedlejším parametrem účinnosti (sekundární endopoint) je dosažení statisticky významného (hladina významnosti p ≤ 0,05) zkrácení počtu hodin umělé plicní ventilace u pacientů.
    E.5.2.1Timepoint(s) of evaluation of this end point
    18 month of Follow-uo
    Po uplynutí 18 měsíců sledování
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of the last patient in the study
    Poslední vizita posledního randomizovaného pacienta
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will be further followed through out the hospitalization at the Clinic for anesthesia, resuscitation and intensive medical care.
    Pacienti budou sledování v rámci hospitalizace na klinice anestezie a resuscitace a intenzivní medicíny
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-12-31
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