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    Clinical Trial Results:
    Comparative efficacy of 3 different nicotine gum products to relieve urge for smoking (urge for nicotine) in healthy smokers

    Summary
    EudraCT number
    		 2009-016679-31
    Trial protocol
    		 DK  
    Global end of trial date
    28 May 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Oct 2021
    First version publication date
    14 Oct 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    F-DK109
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fertin Pharma A/S
    Sponsor organisation address
    Dandyvej 19, Vejle, Denmark, 7100
    Public contact
    Birgitte Hyrup Andersen, Fertin Pharma A/S, bia@fertin.com
    Scientific contact
    Birgitte Hyrup Andersen, Fertin Pharma A/S, bia@fertin.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Oct 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 May 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    28 May 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare 2 test nicotine gum products and a reference nicotine gum product in abstinent smokers with regard to relief of urge for smoking and total nicotine abstinence symptoms after first dose
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Feb 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 35
    Worldwide total number of subjects
    35
    EEA total number of subjects
    35
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    35
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screening: objective examination, urinalysis (cannabis, morphine and cocaine), ECG, standard safety laboratory tests, and vital signs (blood pressure, pulse)

    Period 1
    Period 1 title
    Period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1 Gum A
    Arm description
    		 This study was a 3-way cross-over study. In period 1, arm 1 received the test treatment Gum A, Fertin Pharma A/S 2 mg nicotine gum
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fertin Pharma A/S 2 mg nicotine gum
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicated chewing-gum
    Routes of administration
    Buccal use
    Dosage and administration details
    The gum was chewed following a rhythm provided by a metronome (40 chew pr. minute) for 20 minutes

    Arm title
    		 Group 2 Gum B
    Arm description
    		 This study was a 3-way cross-over study. In period 1, arm 2 received the test treatment Gum B, Fertin Pharma A/S 2 mg nicotine gum
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fertin Pharma A/S 2 mg nicotine gum
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicated chewing-gum
    Routes of administration
    Buccal use
    Dosage and administration details
    The gum was chewed following a rhythm provided by a metronome (40 chew pr. minute) for 20 minutes

    Number of subjects in period 1
    		Group 1 Gum A Group 2 Gum B
    Started
    17
    18
    Completed
    16
    17
    Not completed
    1
    1
         Adverse event, non-fatal
    1
    1
    Period 2
    Period 2 title
    Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Reference product NF
    Arm description
    		 This study was a 3-way cross-over study. In period 2, there was only one arm with all subjects receiving the reference product NF, Nicorette Freshmint® 2 mg nicotine gum
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Nicorette Freshmint® 2 mg nicotine gum
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicated chewing-gum
    Routes of administration
    Buccal use
    Dosage and administration details
    The gum was chewed following a rhythm provided by a metronome (40 chew pr. minute) for 20 minutes

    Number of subjects in period 2
    		Reference product NF
    Started
    33
    Completed
    33
    Period 3
    Period 3 title
    Period 3
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1 Gum B
    Arm description
    		 This study was a 3-way cross-over study. In period 3, arm 1 received the test treatment Gum B, Fertin Pharma A/S 2 mg nicotine gum
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fertin Pharma A/S 2 mg nicotine gum
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicated chewing-gum
    Routes of administration
    Buccal use
    Dosage and administration details
    The gum was chewed following a rhythm provided by a metronome (40 chew pr. minute) for 20 minutes

    Arm title
    		 Group 2 Gum A
    Arm description
    		 This study was a 3-way cross-over study. In period 3, arm 2 received the test treatment Gum A, Fertin Pharma A/S 2 mg nicotine gum
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fertin Pharma A/S 2 mg nicotine gum
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicated chewing-gum
    Routes of administration
    Buccal use
    Dosage and administration details
    The gum was chewed following a rhythm provided by a metronome (40 chew pr. minute) for 20 minutes

    Number of subjects in period 3
    		Group 1 Gum B Group 2 Gum A
    Started
    16
    17
    Completed
    16
    17

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Group 1 Gum A
    Reporting group description
    		 This study was a 3-way cross-over study. In period 1, arm 1 received the test treatment Gum A, Fertin Pharma A/S 2 mg nicotine gum

    Reporting group title
    Group 2 Gum B
    Reporting group description
    		 This study was a 3-way cross-over study. In period 1, arm 2 received the test treatment Gum B, Fertin Pharma A/S 2 mg nicotine gum
    Reporting group title
    Reference product NF
    Reporting group description
    		 This study was a 3-way cross-over study. In period 2, there was only one arm with all subjects receiving the reference product NF, Nicorette Freshmint® 2 mg nicotine gum
    Reporting group title
    Group 1 Gum B
    Reporting group description
    		 This study was a 3-way cross-over study. In period 3, arm 1 received the test treatment Gum B, Fertin Pharma A/S 2 mg nicotine gum

    Reporting group title
    Group 2 Gum A
    Reporting group description
    		 This study was a 3-way cross-over study. In period 3, arm 2 received the test treatment Gum A, Fertin Pharma A/S 2 mg nicotine gum

    Subject analysis set title
    Gum A
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This set of subjects received the test product Gum A, Fertin Pharma A/S 2 mg nicotine

    Subject analysis set title
    Gum B
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This set of subjects received the test product Gum B, Fertin Pharma A/S 2 mg nicotine

    Subject analysis set title
    NF
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This set of subjects received the reference product, Nicorette Freshmint® 2 mg nicotine gum

    Primary: Comparative analysis

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    End point title
    		 Comparative analysis
    End point description
    The primary objective was to compare 2 test nicotine gum products and a reference nicotine gum product in abstinent smokers with regard to relief of urge for smoking and total nicotine abstinence symptoms after first dose. The subjects' urge for smoking and abstinence symptoms were evaluated by questioning the subject. The questions concerned urge for smoking (urge for nicotine) and total nicotine abstinence symptoms and were rated by the subjects on a 100-mm visual analogue scale with words anchored at each end that expressed the 2 most extreme ratings. The efficacy was expressed by C max and AUC(0-35 minutes).
    End point type
    Primary
    End point timeframe
    5-10 minutes before dosing and 2.5, 5.0, 7.5, 10.0, 12.5, 15.0, 17.5 20.0, 25.0, 30.0 and 35.0 minutes after dosing
    End point values
    		 Gum A Gum B NF
    Number of subjects analysed
    12
    10
    11
    Units: 100
    12
    10
    11
    Statistical analysis title
    		 AUC (0-35 min) A-NF
    Comparison groups
    Gum A v NF
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 > 0.05 [1]
    Method
    		 Regression, Linear
    Confidence interval
    Notes
    [1] - The overall ability to relieve urge for smoking expressed as the mean AUC from 0 minutes to 35 minutes did not differ between Gum A versus Gum NF: p= 0.302
    Statistical analysis title
    		 AUC (0-35) B-NF
    Comparison groups
    Gum B v NF
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 > 0.05 [2]
    Method
    		 Regression, Linear
    Confidence interval
    Notes
    [2] - The overall ability to relieve urge for smoking expressed as the mean AUC from 0 minutes to 35 minutes did not differ between Gum B versus Gum NF: p= 0.081
    Statistical analysis title
    		 C max (A-NF)
    Comparison groups
    NF v Gum A
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 > 0.05 [3]
    Method
    		 Regression, Linear
    Confidence interval
    Notes
    [3] - Expressed by Cmax, Gum A compared with Gum NF showed a borderline statistically significant difference (p=0.0575)
    Statistical analysis title
    		 C max (B-NF)
    Comparison groups
    Gum B v NF
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05 [4]
    Method
    		 Regression, Linear
    Confidence interval
    Notes
    [4] - Expressed by Cmax, Gum B was more effective to relieve urge for smoking than Gum NF (p=0.0004)

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Subjects were monitored for adverse events on the days of dosing
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Gum A
    Reporting group description
    		 -

    Reporting group title
    Gum B
    Reporting group description
    		 -

    Reporting group title
    Reference product NF
    Reporting group description
    		 -

    Serious adverse events
    		 Gum A Gum B Reference product NF
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 33 (0.00%)
    0 / 33 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Gum A Gum B Reference product NF
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 33 (9.09%)
    2 / 33 (6.06%)
    0 / 33 (0.00%)
    Gastrointestinal disorders
    Nausea
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 33 (9.09%)
    2 / 33 (6.06%)
    0 / 33 (0.00%)
         occurrences all number
    3
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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