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    Summary
    EudraCT Number:2016-001267-36
    Sponsor's Protocol Code Number:CO-160310091324-SCCT
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-04-13
    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 ConcernedSweden - MPA
    A.2EudraCT number2016-001267-36
    A.3Full title of the trial
    PHARMACODYNAMIC EFFECTS OF NICOTINE MOUTH SPRAY AND CYTISINE TABLET. A STUDY IN HEALTHY SMOKERS.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PHARMACODYNAMIC EFFECTS OF NICOTINE MOUTH SPRAY AND CYTISINE TABLET. A STUDY IN HEALTHY SMOKERS.
    A.4.1Sponsor's protocol code numberCO-160310091324-SCCT
    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 SponsorMcNeil AB
    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 supportMcNeil AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMcNeil AB
    B.5.2Functional name of contact pointGlobal Regulatory Affairs OTC Hsbg
    B.5.3 Address:
    B.5.3.1Street AddressNorrbroplatsen 2 / PO Box 941
    B.5.3.2Town/ cityHelsingborg
    B.5.3.3Post code25109
    B.5.3.4CountrySweden
    B.5.4Telephone number4642288734
    B.5.5Fax number4642288578
    B.5.6E-mailGRAREGH@its.jnj.com
    D. IMP Identification
    D.IMP: 1
    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 Pepparmint 1 mg/spray, munhålespray, lösning
    D.2.1.1.2Name of the Marketing Authorisation holderMcNeil Sweden AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Pepparmint 1 mg/spray
    D.3.4Pharmaceutical form Oromucosal spray, suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal 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 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 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 Tabex 1.5 mg film coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderSopharma Warszawa Sp.
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 nameTabex
    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 INNCYTISINE
    D.3.9.1CAS number 485-35-8
    D.3.9.3Other descriptive nameCytisine
    D.3.9.4EV Substance CodeSUB31171
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    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.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
    Tobacco Dependence
    E.1.1.1Medical condition in easily understood language
    Tobacco Dependence
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
    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
    • to compare ONS, two sprays of 1 mg nicotine, and one Tabex tablet of 1.5 mg cytisine after 12 hours of overnight abstinence with respect to reduction of urges to smoke during the first 5 minutes after start of treatment, and
    • to compare the two treatments with respect to the urges-to-smoke scores at 30, 45, and 60 seconds, 3 and 5 minutes vs. baseline.
    E.2.2Secondary objectives of the trial
    • to compare the study treatments with respect to the estimated time to a 25%, 50%, 75%, and 90% reduction of the baseline urges-to-smoke score,
    • to compare the proportion of subjects reaching 25%, 50%, 75%, and 90% reduction of the baseline urges to smoke within 30, 45, and 60 seconds, 3, 5, and 10 minutes for the study treatments,
    • to describe the urges-to-smoke profile of the study treatments during 2 hours after dose,
    • to compare the study treatments with respect to the urges-to-smoke scores at 30, 45, and 60 seconds, 3 and 5 minutes vs. baseline, and during the first 5 minutes, in the fraction of the subjects reporting “tough” baseline urges to smoke,
    • to compare the study treatments with respect to negative affect related nicotine withdrawal symptoms (depressed mood, irritability, anxiety, and difficulty concentrating),
    • to evaluate preference of the study treatments with respect to craving relief,
    • to evaluate tolerability and safety of the study treatments.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Healthy male or female subject between the ages of 19 and 55 years, inclusive. Health is defined as the absence of clinically relevant abnormalities as judged by the Investigator on the basis of a detailed medical history, physical examination, blood pressure, and pulse rate measurements. The responsible Investigator may request additional investigations or analyses if necessary.
    2. Smoking of at least 10 cigarettes daily during at least one year preceding inclusion.
    3. Smoking within 30 minutes of waking up.
    4. Has a Body Mass Index between 17.5 and 32.0 kg/m2 with a total body weight > 50 kg.
    5. Females: Postmenopausal state (absence of menstrual discharge for at least two years and a serum Follicle Stimulating Hormone (FSH) level exceeding 30 IU/L) or premenopausal/perimenopausal state with an effective means of contraception (oral, injected, implanted, transdermal, hormonal contraceptives, vaginal contraceptive ring, intrauterine device, or status after operative sterilization) during the study and 30 days thereafter, single male partner who has had a vasectomy, or abstinence from heterosexual intercourse, during the study and 30 days thereafter.
    6. Males: No pregnant spouse or partner at screening and willingness to protect potential spouse or partner from becoming pregnant during the study and 30 days thereafter.
    7. A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.
    8. Willingness and ability to comply with scheduled visits, treatment plan, and other study procedures specified in the protocol.
    E.4Principal exclusion criteria
    1. Use of medications other than contraceptives specified in Inclusion Criterion 5 or occasional use of other medications approved by the Investigator.
    2. Known sensitivity to any ingredient of the studied formulations.
    3. Females: pregnancy and/or breastfeeding.
    4. History of alcoholism or substance abuse, as judged by the Investigator, within the past 6 months preceding this study.
    5. Treatment with an investigational drug, other than those described in this protocol, within 3 months preceding this study and until the last treatment visit of the study.
    6. Use of drugs indicated for smoking cessation or history of a quit attempt within than 3 months preceding the screening visit.
    7. Pathological oral status interfering with absorptive function of the oral cavity.
    8. Relationship to persons involved directly with the conduct of the study (i.e., PI; sub Investigators; study coordinators; other study personnel; employees or contractors of the sponsor or Johnson & Johnson subsidiaries; and the families of each).
    E.5 End points
    E.5.1Primary end point(s)
    The primary study endpoints are the mean average score changes from baseline up to 30, 45, and 60 seconds, 3 and 5 minutes and, furthermore, the mean reduction in urges to smoke scores at 30, 45, and 60 seconds, 3 and 5 minutes vs. baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pre-dose and 30, 45, and 60 seconds, 3, and 5 minutes after treatment is given.
    E.5.2Secondary end point(s)
    Secondary endpoints include the times to 25%, 50%, 75%, and 90% reduction of baseline urges-to-smoke scores, the proportion of subjects reaching 25%, 50% 75%, and 90% reduction of the baseline urges to smoke within 30, 45, and 60 seconds, and 3, 5, and 10 minutes, depressed mood, irritability, anxiety and difficulty concentrating, preference of study treatments with respect to craving relief, and observed or spontaneously reported AEs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    30, 45, and 60 seconds, 3, 5 and 10 minutes after treatment is given.
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 Yes
    E.8.2.3.1Comparator description
    Tabex tablet
    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
    End of Study is defined as the time of the last visit of the last subject.
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months2
    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: 64
    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 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 state64
    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 Decision2016-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-07
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