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    Clinical Trial Results:
    A randomised, controlled, open-label, single-centre, parallel group, pilot study to investigate the onset of action of a lozenge compared with a caplet in patients with sore throat.

    Summary
    EudraCT number
    2006-006769-17
    Trial protocol
    GB  
    Global end of trial date
    07 Feb 2008

    Results information
    Results version number
    v1(current)
    This version publication date
    09 Mar 2018
    First version publication date
    09 Mar 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TH0612
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Reckitt Benckiser Healthcare International Ltd
    Sponsor organisation address
    103 - 105 Bath Road, Slough, Berkshire, United Kingdom, SL1 3UH
    Public contact
    Clinical Research, Clinical Research Director, clinicalrequests@rb.com
    Scientific contact
    Clinical Research, Clinical Research Director, clinicalrequests@rb.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
    21 Oct 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Feb 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Feb 2008
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Train a UK centre in the 2-stopwatch technique to evaluate the appropriateness of the 2-stopwatch method in the sore throat indication.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice(GCP) and the ethical principles contained within the Declaration of Helsinki, as referenced in EU Directive 2001/20/EC.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    02 May 2007
    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
    United Kingdom: 23
    Worldwide total number of subjects
    23
    EEA total number of subjects
    23
    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)
    1
    Adults (18-64 years)
    22
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This was a single-centre study, recruited in United Kingdom. 132 subject were screened, out of 109 were screen failures.

    Pre-assignment
    Screening details
    Twenty-three subjects entered the study. Eleven subjects were randomised to receive a single Strefen Honey & Lemon lozenge(flurbiprofen) and 12 randomised to receive a single dose of two Ibuprofen caplets.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    1 x Strefen Honey & Lemon lozenge(flurbiprofen)
    Arm description
    Test : Strefen Honey & Lemon 8.75mg flurbiprofen one lozenge by mouth
    Arm type
    Experimental

    Investigational medicinal product name
    Strefen Honey & Lemon lozenge
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Lozenge
    Routes of administration
    Oral use
    Dosage and administration details
    Strefen Honey & Lemon 8.75mg flurbiprofen one lozenge by mouth

    Arm title
    2 x Ibuprofen Caplets
    Arm description
    Reference : Ibuprofen Caplets, 200mg ibuprofen two caplets by mouth
    Arm type
    Active comparator

    Investigational medicinal product name
    Ibuprofen Caplets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ibuprofen Caplets, 200mg ibuprofen two caplets by mouth

    Number of subjects in period 1
    1 x Strefen Honey & Lemon lozenge(flurbiprofen) 2 x Ibuprofen Caplets
    Started
    11
    12
    Completed
    11
    10
    Not completed
    0
    2
         Protocol deviation
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    1 x Strefen Honey & Lemon lozenge(flurbiprofen)
    Reporting group description
    Test : Strefen Honey & Lemon 8.75mg flurbiprofen one lozenge by mouth

    Reporting group title
    2 x Ibuprofen Caplets
    Reporting group description
    Reference : Ibuprofen Caplets, 200mg ibuprofen two caplets by mouth

    Reporting group values
    1 x Strefen Honey & Lemon lozenge(flurbiprofen) 2 x Ibuprofen Caplets Total
    Number of subjects
    11 12 23
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    33.5 ± 10.6 34.8 ± 14.2 -
    Gender categorical
    Units: Subjects
        Female
    5 9 14
        Male
    6 3 9
    Race
    Units: Subjects
        Caucasian
    11 12 23
    Height
    Units: cm
        arithmetic mean (standard deviation)
    171.4 ± 6.9 167.2 ± 7.4 -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    74.9 ± 16.2 80.7 ± 17.4 -

    End points

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    End points reporting groups
    Reporting group title
    1 x Strefen Honey & Lemon lozenge(flurbiprofen)
    Reporting group description
    Test : Strefen Honey & Lemon 8.75mg flurbiprofen one lozenge by mouth

    Reporting group title
    2 x Ibuprofen Caplets
    Reporting group description
    Reference : Ibuprofen Caplets, 200mg ibuprofen two caplets by mouth

    Primary: Median Time to first confirmed perceptible sore throat pain relief

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    End point title
    Median Time to first confirmed perceptible sore throat pain relief
    End point description
    KM median - Kaplan-Meier median Intention-to-treat (ITT) population consisted of all patients who were randomized to the study, who completed the baseline efficacy assessments and who had at least one post-baseline assessment.
    End point type
    Primary
    End point timeframe
    At Baseline (pre-dose), 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 75, 90, 105 and 120 minutes post-dose
    End point values
    1 x Strefen Honey & Lemon lozenge(flurbiprofen) 2 x Ibuprofen Caplets
    Number of subjects analysed
    11
    12
    Units: minutes
    median (confidence interval 95%)
        Overall
    7.2 (2.6 to 22.6)
    17.6 (15.0 to 22.9)
    Statistical analysis title
    Sore throat relief: lozenge Vs Caplets
    Comparison groups
    1 x Strefen Honey & Lemon lozenge(flurbiprofen) v 2 x Ibuprofen Caplets
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1205
    Method
    Regression, Cox
    Confidence interval

    Secondary: Median time to meaningful sore throat pain relief

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    End point title
    Median time to meaningful sore throat pain relief
    End point description
    KM median - Kaplan-Meier median ITT population.
    End point type
    Secondary
    End point timeframe
    At Baseline (pre-dose), 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 75, 90, 105 and 120 minutes post-dose
    End point values
    1 x Strefen Honey & Lemon lozenge(flurbiprofen) 2 x Ibuprofen Caplets
    Number of subjects analysed
    11
    12
    Units: minutes
        median (confidence interval 95%)
    17.3 (10.2 to 120.7)
    61.3 (32.6 to 78.2)
    No statistical analyses for this end point

    Secondary: Median Time to first unconfirmed perceptible sore throat pain relief

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    End point title
    Median Time to first unconfirmed perceptible sore throat pain relief
    End point description
    KM median - Kaplan-Meier median ITT population.
    End point type
    Secondary
    End point timeframe
    At Baseline (pre-dose), 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 75, 90, 105 and 120 minutes post-dose
    End point values
    1 x Strefen Honey & Lemon lozenge(flurbiprofen) 2 x Ibuprofen Caplets
    Number of subjects analysed
    11
    12
    Units: minutes
        median (confidence interval 95%)
    4.1 (1.1 to 7.2)
    17.6 (16.0 to 22.9)
    No statistical analyses for this end point

    Secondary: Mean change from baseline in throat soreness sore throat relief

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    End point title
    Mean change from baseline in throat soreness sore throat relief
    End point description
    Changes in throat soreness measured using 11-point ordinal scale where 0 = “Not Sore” and 10 = “Very Sore”. ITT population.
    End point type
    Secondary
    End point timeframe
    At Baseline (pre-dose), 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 75, 90, 105 and 120 minutes post-dose
    End point values
    1 x Strefen Honey & Lemon lozenge(flurbiprofen) 2 x Ibuprofen Caplets
    Number of subjects analysed
    11
    12
    Units: unit on scale
    arithmetic mean (standard deviation)
        Baseline
    7.36 ± 0.81
    7.33 ± 0.98
        Post-dose : 5 Minutes
    -1.27 ± 1.62
    -0.25 ± 0.62
        Post-dose : 10 Minutes
    -1.55 ± 1.57
    -0.25 ± 0.62
        Post-dose : 15 Minutes
    -1.82 ± 1.47
    -0.42 ± 0.67
        Post-dose : 20 Minutes
    -1.82 ± 1.54
    -0.75 ± 0.97
        Post-dose : 25 Minutes
    -2.00 ± 1.48
    -1.00 ± 1.04
        Post-dose : 30 Minutes
    -2.00 ± 1.48
    -1.33 ± 1.15
        Post-dose : 35 Minutes
    -2.18 ± 1.40
    -1.55 ± 1.29
        Post-dose : 40 Minutes
    -2.00 ± 1.48
    -1.91 ± 1.14
        Post-dose : 45 Minutes
    -2.00 ± 1.41
    -2.09 ± 1.22
        Post-dose : 60 Minutes
    -2.27 ± 1.85
    -2.64 ± 1.43
        Post-dose : 75 Minutes
    -2.18 ± 1.66
    -3.20 ± 1.40
        Post-dose : 90 Minutes
    -2.09 ± 1.58
    -3.40 ± 1.35
        Post-dose : 105 Minutes
    -2.27 ± 1.56
    -3.90 ± 1.60
        Post-dose : 120 Minutes
    -2.09 ± 1.81
    -3.80 ± 1.87
    No statistical analyses for this end point

    Secondary: Mean change from baseline in difficulty in swallowing

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    End point title
    Mean change from baseline in difficulty in swallowing
    End point description
    Difficulty in swallowing measured using 100 mm VAS with “Not Difficult” on the left hand side of the 100mm line and “Very Difficult” on the right hand side. ITT population.
    End point type
    Secondary
    End point timeframe
    At Baseline (pre-dose), 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 75, 90, 105 and 120 minutes post-dose
    End point values
    1 x Strefen Honey & Lemon lozenge(flurbiprofen) 2 x Ibuprofen Caplets
    Number of subjects analysed
    11
    12
    Units: unit on scale
    arithmetic mean (standard deviation)
        Baseline
    66.5 ± 6.8
    68.0 ± 6.3
        Post-dose : 5 Minutes
    -10.8 ± 16.1
    -0.3 ± 6.4
        Post-dose : 10 Minutes
    -12.7 ± 15.0
    -0.7 ± 6.8
        Post-dose : 15 Minutes
    -13.9 ± 15.2
    -2.4 ± 9.1
        Post-dose : 20 Minutes
    -13.9 ± 14.1
    -9.1 ± 14.5
        Post-dose : 25 Minutes
    -17.3 ± 14.4
    -11.9 ± 15.0
        Post-dose : 30 Minutes
    -17.4 ± 14.6
    -12.3 ± 16.5
        Post-dose : 35 Minutes
    -17.7 ± 16.0
    -14.5 ± 15.9
        Post-dose : 40 Minutes
    -18.2 ± 16.5
    -19.5 ± 15.8
        Post-dose : 45 Minutes
    -18.6 ± 17.2
    -20.2 ± 16.6
        Post-dose : 60 Minutes
    -18.4 ± 18.8
    -23.4 ± 18.8
        Post-dose : 75 Minutes
    -17.5 ± 17.0
    -29.1 ± 17.2
        Post-dose : 90 Minutes
    -18.2 ± 18.0
    -33.0 ± 16.7
        Post-dose : 105 Minutes
    -20.9 ± 19.5
    -37.1 ± 19.6
        Post-dose : 120 Minutes
    -19.1 ± 22.4
    -38.5 ± 23.3
    No statistical analyses for this end point

    Secondary: Mean change for sore throat relief at various time points

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    End point title
    Mean change for sore throat relief at various time points
    End point description
    Sore throat relief measured using 7 point rating scale where assessed to 7 = complete relief, 6 = almost complete relief, 5 = considerable relief, 4 = moderate relief, 3 = mild relief, 2 = slight relief and 1 = no relief. ITT population
    End point type
    Secondary
    End point timeframe
    At 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 75, 90, 105 and 120 minutes post-dose
    End point values
    1 x Strefen Honey & Lemon lozenge(flurbiprofen) 2 x Ibuprofen Caplets
    Number of subjects analysed
    11
    12
    Units: unit on scale
    arithmetic mean (standard deviation)
        Post-dose : 5 Minutes
    2.36 ± 1.57
    1.17 ± 0.39
        Post-dose : 10 Minutes
    2.73 ± 1.42
    1.17 ± 0.39
        Post-dose : 15 Minutes
    2.91 ± 1.45
    1.42 ± 0.67
        Post-dose : 20 Minutes
    2.91 ± 1.51
    1.75 ± 0.62
        Post-dose : 25 Minutes
    3.0 ± 1.48
    2.0 ± 0.74
        Post-dose : 30 Minutes
    3.09 ± 1.51
    2.33 ± 0.89
        Post-dose : 35 Minutes
    3.09 ± 1.58
    2.45 ± 1.13
        Post-dose : 40 Minutes
    3.0 ± 1.55
    2.73 ± 1.10
        Post-dose : 45 Minutes
    3.09 ± 1.51
    3.0 ± 1.34
        Post-dose : 60 Minutes
    3.27 ± 1.56
    3.55 ± 1.44
        Post-dose : 75 Minutes
    2.91 ± 1.30
    4.10 ± 1.45
        Post-dose : 90 Minutes
    2.91 ± 1.38
    4.10 ± 1.60
        Post-dose : 105 Minutes
    2.64 ± 1.57
    4.30 ± 1.64
        Post-dose : 120 Minutes
    2.91 ± 1.76
    4.30 ± 1.83
    No statistical analyses for this end point

    Secondary: Mean scores for overall treatment rating

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    End point title
    Mean scores for overall treatment rating
    End point description
    Overall Treatment Rating assessed using an 11-point ordinal scale where 0 = “Poor” and 10 = “Excellent”. ITT population
    End point type
    Secondary
    End point timeframe
    At 120 mins
    End point values
    1 x Strefen Honey & Lemon lozenge(flurbiprofen) 2 x Ibuprofen Caplets
    Number of subjects analysed
    11
    12
    Units: unit on scale
        arithmetic mean (standard deviation)
    6.27 ± 2.41
    7.80 ± 1.62
    No statistical analyses for this end point

    Secondary: Number of patients issued with Strepsils at Discharge

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    End point title
    Number of patients issued with Strepsils at Discharge
    End point description
    ITT population
    End point type
    Secondary
    End point timeframe
    At 120 minutes post-dose
    End point values
    1 x Strefen Honey & Lemon lozenge(flurbiprofen) 2 x Ibuprofen Caplets
    Number of subjects analysed
    11
    12
    Units: Number of subjects
    11
    12
    No statistical analyses for this end point

    Secondary: Number of Subjects With Adverse Events (AEs)

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    End point title
    Number of Subjects With Adverse Events (AEs)
    End point description
    Intensity was determined by the Investigator. For symptomatic AEs the following definitions were applied: Mild = AE does not limit usual activities; the subject may experience slight discomfort. Moderate = AE results in some limitation of usual activities; the subject may experience significant discomfort. Severe = AE results in an inability to carry out usual activities; the subject may experience intolerable discomfort or pain. Relationship to Investigational Medicinal Products (IMP): Possible = Reasonable suspicion that the AE was caused by the IMP. Unlikely = Slight, but remote, chance that the AE was caused by the IMP, but the balance of judgment is that it was most likely not due to the IMP. Unrelated = No possibility that the AE was caused by the IMP.
    End point type
    Secondary
    End point timeframe
    Up to 12 hours (Visit 1) Safety population consist of all patients taking at least one dose of study medication.
    End point values
    1 x Strefen Honey & Lemon lozenge(flurbiprofen) 2 x Ibuprofen Caplets
    Number of subjects analysed
    11
    12
    Units: Subjects
        Intensity - Mild
    0
    1
        Intensity - Moderate
    0
    0
        Intensity - Severe
    0
    0
        Relationship - Possible
    0
    1
        Relationship - Unlikely
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 12 hours (Visit 1)
    Adverse event reporting additional description
    Safety population.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    1 x Strefen Honey & Lemon lozenge(flurbiprofen)
    Reporting group description
    -

    Reporting group title
    2 x Ibuprofen Caplets
    Reporting group description
    -

    Serious adverse events
    1 x Strefen Honey & Lemon lozenge(flurbiprofen) 2 x Ibuprofen Caplets
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    1 x Strefen Honey & Lemon lozenge(flurbiprofen) 2 x Ibuprofen Caplets
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jun 2007
    The substantial amendments to a clinical trial, dated 20 June 2007, 21 June 2007, 10 October 2007 and 18 October 2007, initiated by the Investigator, documented the study suspension, study recommencement, and a minor change to the Patient Information Sheet, respectively.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    18 Jun 2007
    The temporary halt from 18 June 2007 was due to poor recruitment during the spring/summer season where sore throat of the required intensity was uncommon. The recommencement of the study was in November 2007. The minor change to the Patient Information Sheet included additional side effects (taste perversion and mouth ulcers) of Strefen Honey & Lemon lozeng (flurbiprofen). These changes were made after 7 of 23 subjects had been enrolled and 6 of 21 subjects completed the study.
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was stopped prematurely, before the planned number of subjects was recruited. The study was ended after 23 subjects had been enrolled and 21 of the 23 enrolled subjects completed the study.
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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