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    Summary
    EudraCT Number:2008-006845-13
    Sponsor's Protocol Code Number:A6431111
    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:2008-11-28
    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 number2008-006845-13
    A.3Full title of the trial
    Efficacy and safety following use of a novel nicotine replacement therapy. A multicenter, randomized, double blind, placebo-controlled, parallel group, 52-week study in smokers motivated to quit.
    A.4.1Sponsor's protocol code numberA6431111
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMcNeil AB (Johnson & Johnson Consumer and Personal Products Worldwide, J&J CPPW)
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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 nameNicotine Mouth Spray and/or Oromucosal Nicotine Spray
    D.3.2Product code NMS and/or ONS
    D.3.4Pharmaceutical form Oromucosal spray
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 54115
    D.3.9.3Other descriptive nameNicotine
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number13,6
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboOromucosal spray
    D.8.4Route of administration of the placeboOromucosal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    For the treatment of tobacco dependence by relieving nicotine craving and withdrawal symptoms, thereby facilitating smoking cessation in smokers motivated to quit abruptly.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10008374
    E.1.2Term Cessation of smoking
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10053325
    E.1.2Term Smoking cessation therapy
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10059612
    E.1.2Term Tobacco withdrawal symptoms
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of NMS versus placebo in smokers to achieve continuous abstinence from smoking from the week 2 visit until and including the week 6, week 24, and week 52 visits, respectively.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of NMS versus placebo in smokers to achieve continuous abstinence from smoking from the week 2 visit through all other time points throughout the study (i.e. until and including the week 4, 8, 12, 16, and 20 visits, respectively),
    To evaluate the efficacy of NMS versus placebo in smokers on 7-day point prevalence abstinence from smoking at week 4 and all remaining visits,
    To assess the efficacy of NMS versus placebo in smokers on craving and withdrawal symptoms during the initial four weeks on study (daily ratings), as well as point ratings at weeks 4, 6, 8, 12, 16, 20 and 24,
    To document the compliance of NMS,
    To assess the level of nicotine substitution by measuring saliva cotinine levels,
    To document smoking status throughout the study,
    To evaluate the safety and adverse event profile of NMS, including vital signs,
    To evaluate the product acceptability of NMS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. males and females 18 years or older,
    2. daily cigarette smoker for the last three years or more,
    3. CO level of at least 10 ppm after at least 15 smoke-free minutes,
    4. motivated and willing to completely stop smoking from the day after the baseline visit and to stay smokefree,
    5. willing to use NMS for at least 12 weeks,
    6. female participants of child-bearing potential should have used a medically acceptable means of birth control for at least one month prior to the baseline visit and continue to use birth control during the study period and for one month after the last dose of study drug,
    7. evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and consents to participate,
    8. be willing and able to comply with all study procedures and attend the 11 scheduled visits for the 52 weeks duration of the study,
    9. be willing and able to use an eDiary according to the provided instructions and willing to return the eDiary at the 12-week visit
    E.4Principal exclusion criteria
    1. current use of tobacco-containing products, other than cigarettes (e.g., snuff/snus, chewing tobacco, cigars, or pipe), or smoking of other substances,
    2. use of other NRT, bupropion, or varenicline, or undergoing any treatment for tobacco dependence (e.g. acupuncture), during the previous 6 months,
    3. unstable angina pectoris or myocardial infarction or stroke during the previous 3 months,
    4. pregnancy, lactation or intended pregnancy (non-pregnancy will be verified by urine pregnancy test for female participants of child-bearing potential),
    5. suspected alcohol or drug abuse,
    6. have a member of the same household who is also a subject in the current study,
    7. participation in other clinical trials within the previous 3 months and during study participation,
    8. an acute or chronic medical or psychiatric condition or previously diagnosed clinically important renal or hepatic disease, that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    9. subjects with presence of an oral lesion (suspected malignant lesion and/or erosive lesion), requiring further investigation such as biopsy.
    E.5 End points
    E.5.1Primary end point(s)
    self-reported continuous abstinence from smoking from the week 2 visit until and including the week 6, week 24 and week 52 visits, respectively, verified by an exhaled carbon monoxide (CO) level of less than 10 ppm at all clinic visits from week 2 until and including weeks 6, 24 and 52, respectively. Missing CO measurements at weeks 8, 16 and/or 20 will not disqualify success if subject claims continuous abstinence from smoking, verified by an exhaled CO level of less than 10 ppm at later visits.

    Thus, to be classified as a treatment success:

    - after 6 weeks a subject will have to report no smoking between weeks 2 and 6 and to present a CO level of less than 10 ppm at visits weeks 2, 4 and 6, respectively. Subjects who report use of other-than-study NRT, varenicline or bupropion for smoking cessation anytime between weeks 2 and 6 will be classified as treatment failures.
    - after 24 weeks a subject will have to report no smoking between weeks 2 and 24 and to present a CO level of less than 10 ppm at visits from week 2 to 24, inclusive. Subjects who report use of other-than-study NRT, varenicline or bupropion for smoking cessation anytime between weeks 2 and 24 will be classified as treatment failures. A subject with a missing CO-value at weeks 8, 16 and/or 20 will not be regarded a treatment failure if verified abstinent at later visits, including the 24 weeks visit.
    - after 52 weeks a subject will have to report no smoking between weeks 2 and 52 and to present a CO level of less than 10 ppm at visits from week 2 to 24, inclusive, as well as at visit week 52. Subjects who report use of use other-than-study NRT, varenicline or bupropion for smoking cessation anytime between weeks 2 and 52 will be classified as treatment failures. A subject with a missing CO-value at weeks 8, 16 and/or 20 will not be regarded a treatment failure if verified abstinent at later visits, including the 52 weeks visit.
    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) 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 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.8.3 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 Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 Information not present in EudraCT
    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 in all participating countries is defined as the 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 months2
    E.8.9.1In the Member State concerned days19
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days19
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 No
    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 state310
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 465
    F.4.2.2In the whole clinical trial 465
    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)
    Participants who still smoke at the end of the study will be offered standard smoking cessation treatment at a specialist clinic.
    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 Decision2009-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-06-16
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