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    Summary
    EudraCT Number:2011-000843-26
    Sponsor's Protocol Code Number:201102-TR
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-06-28
    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 ConcernedGermany - BfArM
    A.2EudraCT number2011-000843-26
    A.3Full title of the trial
    Veränderungen im autonomen Nervensystem während der Tabakentwöhnung – Mögliche Effekte pharmakologischer Interventionen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Alterations in the autonomic nervous system during smoking cessation - Possible effects of smoking cessation medication
    A.3.2Name or abbreviated title of the trial where available
    Sympathovagales Gleichgewicht im akuten Tabakentzug
    A.4.1Sponsor's protocol code number201102-TR
    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 SponsorUniversity Medical Center Goettingen
    B.1.3.4CountryGermany
    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 Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Goettingen
    B.5.2Functional name of contact pointStudienzentrum Kardiologie
    B.5.3 Address:
    B.5.3.1Street AddressRobert-Koch-Straße 40
    B.5.3.2Town/ cityGoettingen
    B.5.3.3Post code37075
    B.5.3.4CountryGermany
    B.5.4Telephone number+495513912797
    B.5.5Fax number+49551396887
    B.5.6E-mailraupach@med.uni-goettingen.de
    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 Champix 1 mg Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.1Product nameChampix
    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.3.9.1CAS 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 typeequal
    D.3.10.3Concentration number1
    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 Nicorette TX Pflaster 10 mg
    D.2.1.1.2Name of the Marketing Authorisation holderMcNeil Consumer Healthcare GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.1Product nameNicorette
    D.3.4Pharmaceutical form Transdermal 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.3.9.1CAS 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 typeequal
    D.3.10.3Concentration number10
    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: 3
    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 Nicorette TX Pflaster 15 mg
    D.2.1.1.2Name of the Marketing Authorisation holderMcNeil Consumer Healthcare GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.1Product nameNicorette
    D.3.4Pharmaceutical form Transdermal 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.3.9.1CAS 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 typeequal
    D.3.10.3Concentration number15
    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: 4
    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 Champix 0,5 mg Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.1Product nameChampix
    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.3.9.1CAS 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 typeequal
    D.3.10.3Concentration number0,5
    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: 5
    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 Nicorette TX Pflaster 25 mg
    D.2.1.1.2Name of the Marketing Authorisation holderMcNeil Consumer Healthcare GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.1Product nameNicorette
    D.3.4Pharmaceutical form Transdermal 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.3.9.1CAS 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 typeequal
    D.3.10.3Concentration number25
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    smoking
    E.1.1.1Medical condition in easily understood language
    smoking
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10008374
    E.1.2Term Cessation of smoking
    E.1.2System Organ Class 10041244 - Social circumstances
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assessment of the effect of smoking cessation on the sympathovagal balance in smokers without medication or with Varenicline vs. Placebo or nicotine replacement therapy
    Das primäre Ziel dieser Studie ist, die Auswirkungen eines Tabakentzuges auf das sympathovagale Gleichgewicht bei Rauchern ohne Medikation oder mit Nikotinersatztherapie bzw. Vareniclin vs. Plazebo zu untersuchen.
    E.2.2Secondary objectives of the trial
    • die Bestimmung der basalen sympathischen Nerven-Aktivität bei Rauchern im Vergleich zu Nie-Rauchern
    • Untersuchung anderer Parameter des autonomen Systems wie Baroreflexsensitivität und Herzfrequenzvariabilität vor und während eines Entzuges
    • Bestimmung von Entzugserscheinungen und Craving vor, während und nach dem Entzug
    • Untersuchung der Auswirkung von smoking cues auf das Craving und sympathovagale Gleichgewicht
    • Untersuchung der Rückfallquote nach einem Entzug und Korrelation mit den erhobenen Parametern
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Männliche und weibliche Patienten im Alter von 25 bis 60 Jahren
    • Für Gruppe A-D: Raucher mit der Bereitschaft zur Tabakentwöh-nung und FTNA (Fagerström-Test für Nikotinabhängigkeit) ≥ 5
    • Für die Kontrollgruppe (E): Nie-Raucher
    • Schriftliche Einwilligung der teilnehmenden Person nach erfolgter Aufklärung
    E.4Principal exclusion criteria
    • anamnestisch bekannte Überempfindlichkeit gegenüber einem der eingesetzten Medikamente oder deren Inhaltsstoffe oder gegenüber Medikamenten mit ähnlicher chemischer Struktur
    • Teilnahme an einer anderen klinischen Prüfung während der Prüfung oder innerhalb der letzten 4 Wochen vor dem Einschluss
    • Sucht- oder sonstige Erkrankungen und Umstände, die es der oder dem Betreffenden nicht erlauben, Wesen und Tragweite sowie mögliche Folgen der klinischen Prüfung abzuschätzen
    • schwangere oder stillende Frauen
    • Frauen im gebärfähigen Alter, außer Frauen, die die folgenden Kriterien erfüllen:
    - post-menopausal (12 Monate natürliche Amenorrhoe oder 6 Monate Amenorrhoe mit Serum FSH > 40 mlU/ml)
    - postoperativ (6 Wochen nach beidseitiger Ovarektomie mit oder oh-ne Hysterektomie)
    - regelmäßige und korrekte Anwendung einer Verhütungsmethode mit Fehlerquote < 1 % pro Jahr (z. B. Implantate, Depotspritzen, orale Kontrazeptiva, Intrauterinpessar– IUP)
    - sexuelle Enthaltsamkeit
    • Anzeichen darauf, dass die teilnehmende Person den Prüfplan vo-raussichtlich nicht einhalten wird (z. B. mangelnde Kooperationsbe-reitschaft)
    • Prüfpräparat-bedingter Ausschluss (Nikotinpflaster):
    - Chronisch generalisierte Hauterkrankungen wie Psoriasis, chroni-sche Dermatitis und Urtikaria
    • Prüfpräparat-bedingter Ausschluss (Vareniclin):
    - Schwere Einschränkung der Nierenfunktion (Kreatinin-Clearance <30 ml/min)
    - Epilepsie (keine klinischen Erfahrungen mit Vareniclin)
    - Psychiatrische Erkrankungen wie Schizophrenie, bipolare Störungen und Depression (keine klinischen Erfahrungen mit Vareniclin)
    • Messmethoden-bedingte Ausschlusskriterien:
    • Erkrankungen, die den Sympathikotonus erhöhen können (z.B. Herzinsuffizienz, arterieller Bluthochdruck (>140/90), pulmonal-arterieller Bluthochdruck, obstruktive Schlafapnoe, COPD)
    • Herzrhythmusstörungen
    • Myokardinfarkt innerhalb der letzten 8 Wochen
    • Klinische Hinweise für eine Polyneuropathie
    • Erkrankungen, die mit Schädigung peripherer Nerven einher gehen können (z.B. Diabetes mellitus)
    • Schwere oder lebensbedrohliche Erkrankungen (wie z.B. eine Krebserkrankung mit einer Lebenserwartung unter 5 Jahren), terminale Niereninsuffizienz
    • Behandlung mit antihypertensiven Medikamenten, sympathomimetischen Substanzen (z.B. Theophyllin) oder Raucherentwöhnungs-medikamenten (z.B. NRT, Vareniclin)
    • Sonstige Gründe, die nach Einschätzung des Prüfarztes gegen eine Teilnahme an der Studie sprechen
    E.5 End points
    E.5.1Primary end point(s)
    Primäre Zielgröße ist die Bestimmung der muskulären sympathischen Nervenaktivität (MSNA) in bursts/100 Herzschläge vor und während des Entzuges.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Baseline-Untersuchung
    4-6 Wochen vor Rauchstopp
    • Folge-Untersuchung I
    2 Tage nach Rauchstopp bzw. 4 Wochen nach der Baseline-Untersuchung
    E.5.2Secondary end point(s)
    • Bestimmung der MSNA in bursts/min vor und nach der Exposition zu smoking cues bzw. Eiswasser während des Entzuges
    • Baroreflexsensitivität (BRS)
    • Herzfrequenzvariabilität (HRV)
    • Arterielle Pulswellengeschwindigkeit (aPWV)
    • Blutdruck (mmHg)
    • Punktwerte bei der Evaluation der psychischen Entzugserschei-nungen und Craving mittels der Mood and Physical Symptoms Scale (MPSS) und der hospital anxiety and depression scale (HADS).
    • Nachweis der Rauch-Abstinenz mittels CO in der Ausatemluft und Cotinin-Nachweis im Urin
    • Rückfallquote
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Baseline-Untersuchung
    4 (Gruppe A-C, E) bzw. 6 Wochen (Gruppe D) vor Rauchstopp
    • Medikamentenausgabe/-Rücknahme
    1 Woche vor (Gruppe A, B) bzw. 1 d vor (Gruppe C, D) Rauch-stopp, zusätzlich in Woche 4, 8 und 11 (Gruppe A, B) bzw. 12 Wo-chen (Gruppe C, D) nach Rauchstopp
    • Folge-Untersuchung I
    2 Tage nach Rauchstopp (Grupp A-C) bzw. 4 Wochen nach der Ba-seline-Untersuchung (Gruppe D, E)
    • Folge-Untersuchung II
    (6 Wochen nach Rauchstopp)
    • Folge-Untersuchung III
    (26 Wochen nach Rauchstopp)
    • Telefonische Befragungen
    (3 Tage vor bis 1 Tag nach Rauchstopp, zusätzlich nach Beendigung der medikamentösen Behandlung (Woche 11 (Gruppe A, B) bzw. Woche 12 (Gruppe C, D) nach Rauchstopp)
    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 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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    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 subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    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.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 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 state85
    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)
    Nach erfolgreicher Raucherentwöhnung ist keine Weiterbehandlung erforderlich. Die Patienten können sich jedoch jederzeit an die Raucherentwöhnungsambulanz wenden. Sollte die Raucherentwöhnung nicht erfolgreich sein, besteht jederzeit die Möglichkeit zu einer erneuten Kursteilnahme (außerhalb dieser Studie).
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Institut für anwendungsorientierte Forschung und klinische Studien
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-08-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-03-31
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