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    Summary
    EudraCT Number:2009-015537-67
    Sponsor's Protocol Code Number:2009-08-17
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-10-26
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-015537-67
    A.3Full title of the trial
    Untersuchung der Wirksamkeit und Sicherheit von Vareniclin in der Postakutbehandlung der Alkoholabhängigkeit - eine prospektive, bizentrische, doppelblinde, placebokontrollierte, randomisierte Phase II Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Postaktutbehandlung der Alkoholabhängigkeit
    A.4.1Sponsor's protocol code number2009-08-17
    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 SponsorUniversitätsmedizin der Johannes Gutenberg-Universität Mainz
    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 supportUniversitätsmedizin der Johannes Gutenberg-Universität Mainz
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInterdisziplinäres Zentrum Klinische Studien Mainz
    B.5.2Functional name of contact pointTobias Wittig
    B.5.3 Address:
    B.5.3.1Street AddressLangenbeckstraße 2
    B.5.3.2Town/ cityMainz
    B.5.3.3Post code55131
    B.5.3.4CountryGermany
    B.5.4Telephone number4906131179917
    B.5.5Fax number4906131179914
    B.5.6E-mailwittig@izks-mainz.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 0,5 mg Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, Great Britain
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.9.1CAS number 375815-87-5
    D.3.9.3Other descriptive nameVARENICLINE TARTRATE
    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: 2
    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 Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, Great Britain
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.9.1CAS number 375815-87-5
    D.3.9.3Other descriptive nameVARENICLINE TARTRATE
    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.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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alcohol dependence
    E.1.1.1Medical condition in easily understood language
    Alcohol dependence
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Psychological processes [F02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10001594
    E.1.2Term Alcohol dependence syndrome
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To analyse the efficacy and safety of varenicline (Champix) versus placebo for relapse prevention in post-acute treatment (7-21 after last drink) in alcohol dependent patients.
    E.2.2Secondary objectives of the trial
    Investigation of drinking-quantity reducing properties of varenicline in a group of alcohol dependent patients, as measured by
    - Amount of alcoholic drinks per drinking day
    - Percentage of heavy drinking days (more than six standard drinks for a man and four standard drinks for a woman)
    Safety and tolerability of varenicline in post-acute treatment in alcohol dependent patients
    Investigation of alcohol craving with the OCDS and VAS
    Measurement the overall clinical impression (CGI)
    Measurement of quality of life (SF-12 questionnaire)
    Measurement of the frequency of smoking (number of cigarettes per day and percentage of abstinent days)
    Measurement of nicotine dependence severity (Fagerstrom Index for Nicotine Dependence - FTND)
    Measurement of severity of depression (Beck Depression Inventory - BDI)



    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Alcohol dependent as defined by the criteria of Diagnostic and Statistical Manual of mental disorders (DSM IV)
    Male and female in- or outpatients
    Current smoker
    Aged 18 to 65 years
    Last consumption of alcohol 7-21 days before randomisation
    Detoxified and free of withdrawal symptoms at randomisation
    Sufficient knowledge of German language
    Able to follow verbal and written instructions
    Able to provide written informed consent
    E.4Principal exclusion criteria
    Delirium after current withdrawal, alcohol-induced dementia, Wernicke-Korsakoff syndrome
    Severe renal insufficiency
    Severe liver insufficiency
    Involutary Detoxification
    Female patients pregnant, breast feeding or fo child bearing age and not protected by medically acceptable contraception
    Patients with clinically relevant concomitant psychiatric discorders (including a major depressive episode, psychotic discorders, antisocial personality disorder according to DSM IV in medial history)
    Patients with an addiction or substance abuse of other addiction-inducing substances (except nicotine or cannabis) within the last 24 months before inclusion in the trial
    Patient having a current suicide risk with a score > 6 at the suicidality item C of the M.I.N.I. international neuropsychiatric interview (MINI)
    Patients with any clinically significant acute or chronic progressive neurological, gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, dermatological or respiratory disease
    Patients with a current relevant depression (Hamilton Rating Scale for Depression (German version) values ≥ 9 or Beck Depression Inventory (German version) values ≥ 12)
    Patients with a history of cancer within the last five years
    Patients with a history of stroke or myocardial infarction within the last 6 months before screening
    E.5 End points
    E.5.1Primary end point(s)
    Percent of days abstinent from any alcohol (TLFB) during 12-weeks treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 12 weeks of treatment
    E.5.2Secondary end point(s)
    • Zeit bis zum ersten alkoholischen Getränk/ Trinkzwischenfall (in Tagen), erfasst mittels Time-Line-Follow-Back Interview
    • Anteil dauerhaft abstinenter Patienten während der Behandlung
    (in Prozent der Anzahl der Patienten)
    • Anzahl der Standarddrinks pro Trinktag, erfasst mittels Time-Line-Follow-Back Interview
    • Zeit bis zum ersten schweren Trinken (in Tagen), erfasst mittels Time-Line-Follow-Back Interview
    • Anzahl der Tage mit schwerem Trinken (in Prozent der Behandlungstage), erfasst mittels Time-Line-Follow-Back Interview
    • Veränderungen der Gamma-Glutamyl-Transferase (ץ-GT)
    • Unerwünschte Ereignisse
    • Compliance der Patienten
    • Alkohol Craving gemessen mit der Obsessive Compulsive Drinking Scale (OCDS) und einer Visuellen Analog Skala des Cravings (VAS)
    • Schweregrad der Alkoholabhängigkeit gemessen mit dem EuropASI (siehe 6.1.1.9)
    • Globale Zustandsveränderung gemessen mit der
    Clinical Global Impression of Change (CGI)
    • Lebensqualität (SF-12 Fragebogen)
    • Intensität des Rauchens (Anzahl der Zigaretten/Tag und CO-Messung)
    • Die Anzahl der nikotinabstinenten Behandlungstage (in Prozent der Behandlungstage)
    • Schwere der Nikotinabhängigkeit gemessen mit dem Fagerstrom Test der Nikotinabhängigkeit (FTND)
    • Intensität der depressiven Beschwerden
    [gemessen mit dem Beck Depressions Inventar (BDI)]
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 12 weeks of treatment
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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) No
    E.8.2.2Placebo Yes
    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 concerned2
    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
    end of trial ist last visit of the last patient
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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.1.2.1Number of subjects for this age range: 40
    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 state40
    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)
    see protocoll chapter 3.6.2 and chapter 4.1.7
    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 Decision2009-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-10-04
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