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    Summary
    EudraCT Number:2017-004715-40
    Sponsor's Protocol Code Number:BRU-VCN-2017
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-04-09
    Trial results View 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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-004715-40
    A.3Full title of the trial
    An effectiveness and safety study of Varenicline for smoking cessation in hospitalized patients with psychiatric disorders.
    Estudio de eficacia y seguridad de vareniclina para dejar de fumar en pacientes hospitalizados con trastornos psiquiátricos.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    We try to assess the effectiveness and safety of Varenicline for smoking cessation in hospitalized patients with psychiatric disorders.
    Evaluar la efectividad para dejar de fumar y la seguridad de vareniclina en pacientes hospitalizados con enfermedades psiquiátricas.
    A.4.1Sponsor's protocol code numberBRU-VCN-2017
    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 SponsorFundació Hospital Universitari Vall d’Hebron-Institut de Recerca (VHIR)
    B.1.3.4CountrySpain
    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 supportPfizer
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació Hospital Universitari Vall d’Hebron-Institut de Recerca (VHIR)
    B.5.2Functional name of contact pointPsychiatry Department Vall d’Hebron
    B.5.3 Address:
    B.5.3.1Street AddressPg. de la Vall d’Hebron, 119-129
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number3493489 42 95
    B.5.5Fax number3493489 45 87
    B.5.6E-mailebruguer@vhebron.net
    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 CHANTIX (varenicline) tablets, for oral use
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVARENICLINE
    D.3.9.1CAS number 375815-87-5
    D.3.9.3Other descriptive nameVARENICLINE TARTRATE
    D.3.9.4EV Substance CodeSUB22601
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.5 to 2
    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 No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 NICOTINELL TTS
    D.2.1.1.2Name of the Marketing Authorisation holderGSK
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNICOTINE
    D.3.9.1CAS number 54-11-5
    D.3.9.3Other descriptive nameNICOTINE
    D.3.9.4EV Substance CodeSUB14645MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number7 to 21
    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 No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Smoking cessation in hospitalized patients with psychiatric disorders.
    Cese del hábito tabáquico en pacientes hospitalizados con trastornos psiquiátricos.
    E.1.1.1Medical condition in easily understood language
    Hospitalized patients with psychiatric disorders who undergo a treatment with varenicline or nicotine to quit smoking.
    Pacientes hospitalizados con enfermedades psiquiátricas que aceptan tratamiento con vareniclina o nicotina para dejar de fumar.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    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
    This study will compare varenicline to nicotine patch initiated in-hospital on smoking abstinence rates post-discharge. In addition, safety will be assessed by comparing the incidence of severe neuropsychiatric adverse events in participants with varenicline or nicotine patch.
    Este estudio comparará la abstinencia tabáquica post-alta entre sujetos que hayan iniciado tratamiento durante la hospitalización con vareniclina o con parches de nicotina. Adicionalmente, se evaluará la seguridad comparando la incidencia de efectos adversos neuropsiquiátricos severos entre los participantes con vareniclina o con parches de nicotina.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18-65 years old.
    2. Good understanding of protocol to informed consent.
    3. Hospitalized for a mental health condition at one of the three acute psychiatric
    facilities who participate in this study.
    4. Having at least a psychiatric disorder according to DSM-5.
    5. Living in Barcelona city or in the metropolitan area.
    6. Not being at high risk of self-injury or suicidal behavior, in the opinion of the
    Investigator.
    7. Smoking an average of at least 10 cigarettes per day during the year before hospital admission.
    8. Females who are not childbearing potential (surgical sterilized or at least 2 years postmenopausal) and who are not nursing may be included. Females who are childbearing potential may be included if they agree to avoid pregnancy during the study, and agree to use a birth control method.
    9. Able to comply with schedule visits, treatment plan and study procedures.
    10. Signed and dated informed consent indicating that the participant has been
    informed of all aspects of the study.
    1. Edad de 18-65 años.
    2. Suficiente comprensión del protocolo para participar en el estudio.
    3. Hospitalización por enfermedad mental en uno de los tres centros psiquiátricos de agudos que participan en el estudio.
    4 Diagnóstico de al menos un trastorno psiquiátrico de acuerdo con el DSM-5.
    5. Residencia en Barcelona ciudad o área metropolitana.
    6. No presentar riego de conducta autolesiva o suicida, a juicio clínico del investigador.
    7. Fumar 10 cigarrillos o más al día durante el año previo a la hospitalización.
    8. Mujeres infértiles (por esterilizadción quirúrgica o menopausia, al menos 2 años previa a la hospitalización) y fuera del periodo de lactancia. Las mujeres fértiles pueden acceder bajo el compromiso de evitar el embarazo y utilizar algun método anticonceptivo durante todo el estudio.
    9. Capacidad de cumplir con las visitas programadas, el tratamiento pautado y los prodecimientos del estudio.
    10. Firmar y fechar consentimiento informado indicando que el paciente ha recibido toda la información necesaria para su participación en el estudio.
    E.4Principal exclusion criteria
    1. History of suicide attempt in the previous year.
    2. Not agree to abstain from cannabis.
    3. Taking bupropion.
    4. Recent (less than two months) myocardial infarction.
    5. Previous adverse reaction that the investigator considers due to varenicline/nicotine patch and of sufficient concern that further exposure to
    varenicline/nicotine patch would be inadvisable.
    6. Severe renal insufficiency.
    7. Pregnancy or lactation.
    8. Other severe acute or chronic medical or psychiatric condition that would make the subject inappropriate for entry into this study.
    1. Historial de intento de suicidio en el último año.
    2. No aceptar la abstinencia de cannabis.
    3. Tratamiento actual con bupropión.
    4. Infarto de miocardio reciente (menos de 2 meses).
    5. Reacciones adversas previas que el investigador asocie a vareniclina o a parches de nicotina, y que generen suficiente preocupación sobre una futura exposición a vareniclina o nicotina, desaconsejando su uso.
    6. Insuficiencia renal grave.
    7. Embarazo o lactancia.
    8. Otras condiciones médicas o psiquiátricas agudas o crónicas que desaconsejasen la entrada del paciente al estudio.
    E.5 End points
    E.5.1Primary end point(s)
    EFFICACY
    1.To compare smoking abstinence rates of varenicline relative to nicotine patch measured by CO-confirmed continuous abstinence rate (CAR) between week 9 and week 12.

    2. To compare smoking abstinence rates of varenicline relative to nicotine patch measured by CO-confirmed continuous abstinence rate (CAR) between week 12 and week 16.

    SAFETY
    1. The primary safety endpoint is the occurrence of at least one treatment emergent “severe” neuropsychiatric event during or after hospitalization. In case of a preexisting "severe" neuropsychiatric event, only a worsening of this event will be reported.
    EFICACIA
    1. Comparar la abstinencia de tabaco de vareniclina con la de parches de nicotina, medidos mediante el índice CAR (CO-confirmed continuous Abstinence Rate), entre las semanas 9 y 12.

    2. Comparar la abstinencia de tabaco de vareniclina con la de parches de nicotina, medidos mediante el índice CAR (CO-confirmed continuous Abstinence Rate), entre las semanas 12 y 16.

    SEGURIDAD
    1. La ocurrencia de al menos un efecto adverso neuropsiquiátrico grave durante o después de la hospitalización. En caso de eventos neuropsiquiátricos graves ya pre-existentes, solamente el empeoramiento será considerado.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy: week 9-12 and week 12-16
    Safety: number of severe neuropsychiatric events from the screening to the end of study.
    Eficacia: semana 9-12 y semana 12-16.
    Seguridad: número de eventos neuropsiquiátricos graves desde el screening hasta el final del estudio.
    E.5.2Secondary end point(s)
    EFFICACY
    1. To compare smoking abstinence rates of varenicline relative to nicotine patch measured by 7-day CO-confirmed abstinence at week 16.

    2. To compare smoking withdrawal symptoms of varenicline relative to nicotine patch during and after hospitalization.

    SAFETY

    It will be individual subscales scores on the following questionnaires:

    - Hospital Anxiety and Depression Scale (HADS),
    - Columbia Suicide Severity Rating Scale (C-SSRS),
    - Clinical Global Impression of Improvement (CGI-I)
    EFICACIA
    1. Comparar la abstinencia puntual (última semana) de tabaco de vareniclina con parches de nicotina, mediante confirmación de niveles de moóxido de carbono en aire expirado (CO) en la semana 16.

    2. Comparar síndrome de abstinencia a la nicotina entre los participantes que toman vareniclina y los que usan parches de nicotina, durante y tras la hospitalización.
    E.5.2.1Timepoint(s) of evaluation of this end point
    0, week 1, week 2, week 3, week 4, week 5, week 7, week 9, week 12, week 16.
    0, semana 1, semana 2, semana 3, semana 4, semana 5, semana 7, semana 9, semana 12, semana 16.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    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
    LSVS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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: 124
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state124
    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)
    None
    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 Decision2018-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-02-15
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