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    Summary
    EudraCT Number:2011-002796-41
    Sponsor's Protocol Code Number:NICTDP0002
    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:2011-08-31
    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 number2011-002796-41
    A.3Full title of the trial
    A PROOF OF CONCEPT WITH A NEW NICOTINE INHALER IN COMPARISON WITH NICOTINE INHALER 10 MG
    - AN EXPLORATORY STUDY IN ADULT HEALTHY SMOKERS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A PROOF OF CONCEPT WITH A NEW NICOTINE INHALER IN COMPARISON WITH NICOTINE INHALER 10 MG
    - AN EXPLORATORY STUDY IN ADULT HEALTHY SMOKERS
    A.4.1Sponsor's protocol code numberNICTDP0002
    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 pointJohan Berglund
    B.5.3 Address:
    B.5.3.1Street AddressNorrbroplatsen 2 / P.O. Box 941
    B.5.3.2Town/ cityHelsingborg
    B.5.3.3Post code25109
    B.5.3.4CountrySweden
    B.5.4Telephone number4642288204
    B.5.5Fax number4642288130
    B.5.6E-mailjberglun@its.jnj.com
    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 Short Filter 1/3 Inhaler 5 mg
    D.3.2Product code N1/3-I5
    D.3.4Pharmaceutical form Inhalation vapour
    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.3.9.1CAS 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 number5
    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 inhalator 10mg
    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 10mg
    D.3.4Pharmaceutical form Inhalation vapour
    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.3.9.1CAS 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/g milligram(s)/gram
    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.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
    Nicotine withdrawal symptoms
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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
    The primary objective of this study is to compare the steady-state nicotine pharmacokinetics (as described by the maximum observed nicotine plasma concentration, Cmax; average nicotine plasma concentration, Cav; and the area under the nicotine plasma concentration-vs.-time curve, AUCt during the last dosing interval) of Nicotine Short Filter 1/3 Inhaler 5 mg (N1/3-I5) given every hour with that of Nicotine Inhaler 10 mg given every hour.
    E.2.2Secondary objectives of the trial
    •to further describe the steady-state nicotine pharmacokinetics with respect to the time to Cmax (tmax), the minimum observed nicotine plasma concentration (Cmin), the peak-trough fluctuation (PTF), and the swing during the last dosing interval,
    •to compare treatments with respect to baseline-corrected nicotine plasma concentrations immediately before each user session (Cn),
    •to compare treatments with respect to easiness of use,
    •to compare treatments with respect to overall liking,
    •to assess urges to smoke at specified time points during both treatments,
    •to compare treatments with respect to the amounts of nicotine released from N1/3-I5 and Nicotine Inhaler 10 mg,
    •to evaluate the tolerability of the treatments in terms of reported and observed adverse events (AE).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Healthy male or female subjects between the ages of 19 and 50 years, inclusive. Health is defined as the absence of clinically relevant abnormalities, as judged by the investigator or an authorized physician on the basis of a detailed medical history, physical examination, blood pressure and pulse rate measurements, 12-lead electrocardiogram as well as clinical laboratory tests. The responsible physician may request additional investigations or analyses if considered necessary.
    2.Smoking of at least 10 cigarettes daily during at least one year preceding inclusion.
    3.For females: Postmenopausal state (absence of menstrual discharge for at least two years and a serum FSH level exceeding 30 IU/L) or premenopausal/perimenopausal state with an effective means of contraception (oral, injected or implanted hormonal contraceptives, intrauterine device, or status after operative sterilization), or declared absence of sexual contact with a male partner during the study. For males: No pregnant spouse or partner at screening and willingness to protect potential spouse or partner from becoming pregnant during the study.
    4.Body Mass Index (BMI) between 17.5 and 30.0 kg/m2 and a total body weight more or equal to 55.0 kg.
    5.A personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
    6.Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified in the protocol.
    E.4Principal exclusion criteria
    1.Evidence or history of an acute or chronic medical or psychiatric condition or allergy or laboratory abnormality, or of use of drugs that, in the judgment of the investigator or an authorized study physician, may increase the risk associated with study participation or interfere with the interpretability of study results.
    2.Females: Pregnancy, breast-feeding, premenopausal, or perimenopausal, state with insufficient contraception as specified under Inclusion Criteria.
    Males: Pregnant spouse or partner or no willingness to prevent conception in a spouse or partner.
    3.History of regular alcohol consumption in the 6 months before screening exceeding weekly limits of 2 L of wine or 5 L of beer or 0.6 L of spirits for females and 3 L of wine or 7.5 L of beer or 0.9 L of spirits for males. The investigator may lower these limits if a subject consumes different types of alcoholic beverages.
    4.Treatment with an investigational drug within 3 months preceding the first dose of study treatment.
    5.Donation or loss of blood within 3 months prior to the first treatment visit if the estimated lost blood volume equaled or exceeded 450 mL.
    6.Known sensitivity to heparin or history of heparin-induced thrombocytopenia.
    7.Pathological oral status interfering with normal muscular, sensory, or absorptive function of the oral cavity. Piercing of tongue and lips is considered to impair oral function.
    8.Relationship to persons involved directly with the conduct of the study (i.e., principal investigator, subinvestigators, study coordinators, other study personnel, employees or contractors of the sponsor or Johnson & Johnson subsidiaries, and the family of each).
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoints are the maximum observed concentration (Cmax) and the average concentration (Cav) during the last dosing interval, and the area under the nicotine plasma concentration-vs.-time curve during the last 60-minute dosing interval (AUCt).
    The dosing interval (t) in this study will be one (1) hour. Consequently, Cav will have the same value as AUCt (but with a different unit), since Cav is calculated as AUCt divided by t. Therefore Cav will not be displayed in the report, only AUCt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    11 hours, 11 hours and 5 minutes, 11 hours and 10 minutes, 11 hours and 15 minutes, 11 hours and 20 minutes, 11 hours and 25 minutes, 11 hours and 30 minutes, 11 hours and 45 minutes, and 12 hours after start of the first administration.
    E.5.2Secondary end point(s)
    Secondary endpoints are time to Cmax (tmax), the minimum observed concentration (Cmin), the peak-trough fluctuation (PTF) and the swing during the last dosing interval, subjects ratings of easiness of use, overall liking and urges to smoke, released amount of nicotine from inhalers, and the occurrence of adverse events (AEs).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pharmacokinetic: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 hours, 11 hours and 5 minutes, 11 hours and 10 minutes, 11 hours and 15 minutes, 11 hours and 20 minutes, 11 hours and 25 minutes, 11 hours and 30 minutes, 11 hours and 45 minutes, and 12 hours after start of the first administration.
    Easiness of use: 10 minutes after the start of administrations at 3, 6, and 9 hours.
    Overall liking: 12 hours
    Urges to smoke: Immediately before and at 15 minutes after the first administration, and as well as before and 15 minutes after the start of administrations at 3, 6, and 9 hours, and at 12 hours.
    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 No
    E.6.6Pharmacokinetic Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    exploratory comparison of different formulations
    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 No
    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 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 years0
    E.8.9.1In the Member State concerned months2
    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 months2
    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: 36
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 36
    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)
    No treatment.
    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 Decision2011-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-12-14
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