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    Clinical Trial Results:
    Clinical Trials with lozenge as local anaesthesia as treatment of oral pain in burning mouth syndrome and Sjögrens syndrome

    Summary
    EudraCT number
    		 2011-006196-19
    Trial protocol
    		 DK  
    Global end of trial date
    15 Jan 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Sep 2019
    First version publication date
    21 Sep 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OC003SB
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01584947
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Clinical Research Centre, Amager and Hvidovre Hospital
    Sponsor organisation address
    Kettegård allé 30, Hvidovre, Denmark,
    Public contact
    Charlotte Treldal, Clinical Research Centre, Amager and Hvidovre Hospital, 0045 38626077, sugetablet@gmail.com
    Scientific contact
    Charlotte Treldal, Clinical Research Centre, Amager and Hvidovre Hospital, 0045 38626077, sugetablet@gmail.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
    14 Jan 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jan 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jan 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The effect of the treatment with respectively bupivacaine- and placebo lozenges on subjective symptoms in burning mouth syndrome, Sjögren's syndrome and lichen planus such as pain in the oral mucosa, oral dryness and taste disturbances
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 25
    Worldwide total number of subjects
    25
    EEA total number of subjects
    25
    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)
    21
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The participants were recruited among patients attending or referred to the Oral Medicine clinic, Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen, during the period from April 2012 to January 2014

    Pre-assignment
    Screening details
    		 The inclusion criteria were a diagnosis of BMS, age of 18 to 75 years, fertile women had to use effective contraception, ability to speak and understand Danish and ability to give informed consent. The patients were diagnosed with BMS on the basis of symptoms and clinical and paraclinical investigations.

    Period 1
    Period 1 title
    baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    The randomization allocation list was done by a statistician and was carried out using the statistical program R version 3.0.1. The containers with the lozenges were sequentially numbered and assigned period 1 or period 2 in correlation with the randomization list. The first patient then received container 1, period 1 and container 1, period 2 and so forth.

    Arms
    Arm title
    		 baseline
    Arm description
    		 -
    Arm type
    		 baseline

    Investigational medicinal product name
    Bupivacaine lozenge
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Lozenge
    Routes of administration
    Oral use
    Dosage and administration details
    Lozenges containing 5 mg bupivacaine and placebo lozenges both with a size of 12-mm diameter were manufactured by direct compression, at the Pharmacy of the Capital Region, Denmark. Both the placebo and the bupivacaine lozenge were taste masked with liquorice powder as it can disguise the bitter taste of bupivacaine. Patients were asked to take three lozenges each day in the treatment period, one after breakfast, one after lunch and one after dinner. The lozenges were administrated after meals to sustain the local anesthetic effect as long as possible. Patients were instructed to suck on the lozenge until it was completely dissolved, to avoid the use of other medical lozenges and to avoid intake of food and drinks for a minimum of 30 minutes after the lozenge was dissolved.

    Investigational medicinal product name
    Placebo lozenge
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Lozenge
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Lozenges containing 5 mg bupivacaine and placebo lozenges both with a size of 12-mm diameter were manufactured by direct compression, at the Pharmacy of the Capital Region, Denmark. Both the placebo and the bupivacaine lozenge were taste masked with liquorice powder as it can disguise the bitter taste of bupivacaine. Patients were asked to take three lozenges each day in the treatment period, one after breakfast, one after lunch and one after dinner. The lozenges were administrated after meals to sustain the local anesthetic effect as long as possible. Patients were instructed to suck on the lozenge until it was completely dissolved, to avoid the use of other medical lozenges and to avoid intake of food and drinks for a minimum of 30 minutes after the lozenge was dissolved.

    Number of subjects in period 1
    		baseline
    Started
    25
    Completed
    25
    Period 2
    Period 2 title
    Treatment period 1
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    The patients were randomized to receive bupivacaine lozenges in one treatment period and placebo lozenges in another treatment period.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lozenge active
    Arm description
    		 The patients were randomized to receive bupivacaine lozenges
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bupivacaine lozenge
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Lozenge
    Routes of administration
    Oral use
    Dosage and administration details
    Lozenges containing 5 mg bupivacaine and placebo lozenges both with a size of 12-mm diameter were manufactured by direct compression, at the Pharmacy of the Capital Region, Denmark. Both the placebo and the bupivacaine lozenge were taste masked with liquorice powder as it can disguise the bitter taste of bupivacaine. Patients were asked to take three lozenges each day in the treatment period, one after breakfast, one after lunch and one after dinner. The lozenges were administrated after meals to sustain the local anesthetic effect as long as possible. Patients were instructed to suck on the lozenge until it was completely dissolved, to avoid the use of other medical lozenges and to avoid intake of food and drinks for a minimum of 30 minutes after the lozenge was dissolved.

    Arm title
    		 Lozenge placebo
    Arm description
    		 The patients were randomized to placebo lozenges
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo lozenge
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Lozenge
    Routes of administration
    Oral use
    Dosage and administration details
    Lozenges containing 5 mg bupivacaine and placebo lozenges both with a size of 12-mm diameter were manufactured by direct compression, at the Pharmacy of the Capital Region, Denmark. Both the placebo and the bupivacaine lozenge were taste masked with liquorice powder as it can disguise the bitter taste of bupivacaine. Patients were asked to take three lozenges each day in the treatment period, one after breakfast, one after lunch and one after dinner. The lozenges were administrated after meals to sustain the local anesthetic effect as long as possible. Patients were instructed to suck on the lozenge until it was completely dissolved, to avoid the use of other medical lozenges and to avoid intake of food and drinks for a minimum of 30 minutes after the lozenge was dissolved.

    Number of subjects in period 2
    		Lozenge active Lozenge placebo
    Started
    12
    13
    Completed
    10
    13
    Not completed
    2
    0
         Consent withdrawn by subject
    2
    -
    Period 3
    Period 3 title
    Treatment period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    The randomization allocation list was done by a statistician and was carried out using the statistical program R version 3.0.1. The containers with the lozenges were sequentially numbered and assigned period 1 or period 2 in correlation with the randomization list. The first patient then received container 1, period 1 and container 1, period 2 and so forth.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active lozenge
    Arm description
    		 The patients were randomized to receive bupivacaine lozenges
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bupivacaine lozenge
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Lozenge
    Routes of administration
    Oral use
    Dosage and administration details
    Lozenges containing 5 mg bupivacaine and placebo lozenges both with a size of 12-mm diameter were manufactured by direct compression, at the Pharmacy of the Capital Region, Denmark. Both the placebo and the bupivacaine lozenge were taste masked with liquorice powder as it can disguise the bitter taste of bupivacaine. Patients were asked to take three lozenges each day in the treatment period, one after breakfast, one after lunch and one after dinner. The lozenges were administrated after meals to sustain the local anesthetic effect as long as possible. Patients were instructed to suck on the lozenge until it was completely dissolved, to avoid the use of other medical lozenges and to avoid intake of food and drinks for a minimum of 30 minutes after the lozenge was dissolved.

    Arm title
    		 Placebo lozenge
    Arm description
    		 The patients were randomized to receive placebo lozenges
    Arm type
    		 Placebo

    Investigational medicinal product name
    Bupivacaine lozenge
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Lozenge
    Routes of administration
    Oral use
    Dosage and administration details
    Lozenges containing 5 mg bupivacaine and placebo lozenges both with a size of 12-mm diameter were manufactured by direct compression, at the Pharmacy of the Capital Region, Denmark. Both the placebo and the bupivacaine lozenge were taste masked with liquorice powder as it can disguise the bitter taste of bupivacaine. Patients were asked to take three lozenges each day in the treatment period, one after breakfast, one after lunch and one after dinner. The lozenges were administrated after meals to sustain the local anesthetic effect as long as possible. Patients were instructed to suck on the lozenge until it was completely dissolved, to avoid the use of other medical lozenges and to avoid intake of food and drinks for a minimum of 30 minutes after the lozenge was dissolved.

    Number of subjects in period 3
    		Active lozenge Placebo lozenge
    Started
    10
    13
    Completed
    7
    8
    Not completed
    3
    5
         Consent withdrawn by subject
    1
    1
         Protocol deviation
    2
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    baseline
    Reporting group description
    		 -

    Reporting group values
    		 baseline Total
    Number of subjects
    		 25 25
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 21 21
        From 65-84 years
    		 4 4
    Age continuous
    Units: years
        median (full range (min-max))
    		 60 (39 to 71) -
    Gender categorical
    Units: Subjects
        Female
    		 21 21
        Male
    		 4 4

    End points

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    End points reporting groups
    Reporting group title
    baseline
    Reporting group description
    		 -
    Reporting group title
    Lozenge active
    Reporting group description
    		 The patients were randomized to receive bupivacaine lozenges

    Reporting group title
    Lozenge placebo
    Reporting group description
    		 The patients were randomized to placebo lozenges
    Reporting group title
    Active lozenge
    Reporting group description
    		 The patients were randomized to receive bupivacaine lozenges

    Reporting group title
    Placebo lozenge
    Reporting group description
    		 The patients were randomized to receive placebo lozenges

    Primary: Effect

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    End point title
    		 Effect
    End point description
    End point type
    Primary
    End point timeframe
    Each treatment period lasted for two weeks.
    End point values
    		 Lozenge active Lozenge placebo Active lozenge Placebo lozenge
    Number of subjects analysed
    12
    13
    10
    13
    Units: millimeter(s)
        median (full range (min-max))
    -5.5 (-7.4 to -3.6)
    -5.5 (-7.4 to -3.6)
    -5.5 (-7.4 to -3.6)
    -5.5 (-7.4 to -3.6)
    Statistical analysis title
    		 Effect
    Comparison groups
    Lozenge active v Lozenge placebo v Active lozenge v Placebo lozenge
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 > 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.4
         upper limit
    		 -3.6
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    • Bivirkninger eller hændelser relateret til medicinen vil blive registreret fra det øjeblik, patienten modtager medicinen og de efterfølgende 24 timer. • Opstår der bivirkninger eller hændelser vil de blive fulgt, til de er ophørt.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Lægemiddelstyrelsen
    Dictionary version
    NA
    Reporting groups
    Reporting group title
    Burning Mouth Syndrome
    Reporting group description
    		 -

    Serious adverse events
    		 Burning Mouth Syndrome
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Burning Mouth Syndrome
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 25 (52.00%)
    Skin and subcutaneous tissue disorders
    Burning sensation
    Additional description: The side effects regarding the bupivacaine lozenge were mild and included increased but tolerable burning or stinging sensation, swallowing discomfort and ceased or altered taste sensation. Side effects experienced after treatment with the placebo lo
         subjects affected / exposed
    13 / 25 (52.00%)
         occurrences all number
    13

    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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