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    Clinical Trial Results:
    A single centre, randomised, single-blind, parallel group single dose study to compare the speed of onset of ibuprofen gel, ibuprofen gel with levomenthol, and diclofenac gel in the relief of pain from strains, sprains and sports injuries.

    Summary
    EudraCT number
    		 2015-005240-33
    Trial protocol
    		 GB  
    Global end of trial date
    15 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 May 2017
    First version publication date
    26 May 2017
    Other versions
    Summary report(s)
    		 Clinical study report

    Trial information

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    Trial identification
    Sponsor protocol code
    MENTH001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Ascension Trial: Short name
    Sponsors
    Sponsor organisation name
    The Mentholatum Company
    Sponsor organisation address
    1 Redwood Avenue,Peel Park Campus, East Kilbride, United Kingdom, G74 5PE
    Public contact
    Dr Gordon Crawford, CPS Research and Patients Direct, +44 0141 946 7888, gordon@cpsresearch.co.uk
    Scientific contact
    Dr Gordon Crawford, CPS Research and Patients Direct, +44 0141 946 7888, gordon@cpsresearch.co.uk
    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
    15 Jun 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jun 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to determine the time to onset of significant pain relief in patients with soft tissue injuries of ibuprofen gel, ibuprofen gel with levomenthol, and diclofenac gel.
    Protection of trial subjects
    This was a non-invasive trial measuring pain relief in marketed products. The marketed products used have a well established pain relief profile.
    Background therapy
    		 -
    Evidence for comparator
    		 Deep Relief (contains ibuprofen and levomenthol) and an ibuprofen gel product were compared in this study in terms of speed of onset so that any differences could be attributed to the levomenthol in Deep Relief. Voltarol Pain-eze Emugel was used to compare the speed of onset between diclofenac and ibuprofen.
    Actual start date of recruitment
    01 Mar 2016
    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
    United Kingdom: 182
    Worldwide total number of subjects
    182
    EEA total number of subjects
    182
    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)
    5
    Adults (18-64 years)
    176
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited into the study via referrals from local pharmacies, healthcare professionals, or by direct responses from study advertising. Those who referred to the study or responding to an advertisement spoke to a trained representative who asked them questions to determine whether they should be included in the trial.

    Pre-assignment
    Screening details
    		 A total of 762 repondents were screened by telephone. Patients admitted if they gave written informed consent, were between the ages of 16 and 75 (inclusive), had an acute soft tissue injury, and had at least moderate pain (greater than or equal to 6 on an NRS for pain) at baseline. Patients randomised to one of 3 treatment groups.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    Randomised treatment was administered by 1 trained member of staff and another supervised the assessments. This enabled both patient and staff supervising the assessments to remain blinded. As levomenthol has a distinctive odour the assessment rooms were mentholised to mask this. Drug supplies were packaged and labelled to GMP standards according to a computer produced randomisation schedule.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ibuprofen
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ibuprofen gel 5% W/W
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Subjects received a single trial medication pack containing 35g of Ibuprofen gel 5% W/W for application to skin at baseline. A single application of gel was applied according to product instructions by a trained member of staff.

    Arm title
    		 Diclofenac
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Diclofenac gel
    Investigational medicinal product code
    Other name
    Voltarol Pain-ese Emulgel
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Patients received a single trial pack containing 30g of Diclofenac gel (Voltarol Pain-ese Emulgel 1.16%). A single application of gel was applied to the skin according to product instructions by a trained member of staff

    Arm title
    		 Deep Relief
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ibuprofen gel 5% W/W with Levomenthol 3% W/W
    Investigational medicinal product code
    Other name
    Deep Relief
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Patients received a single trial pack containing 30g of Ibuprofen gel 5% W/W with Levomenthol 3% W/W for application to the skin. A single application was made according to product instructions by a trained member of staff

    Number of subjects in period 1
    		Ibuprofen Diclofenac Deep Relief
    Started
    61
    61
    60
    Completed
    61
    61
    59
    Not completed
    0
    0
    1
         Data collection method failed during follow up
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 182 182
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Age distribtuion for the 182 participants eligible to take part in the study
    Units: years
        arithmetic mean (full range (min-max))
    		 36.18 (17 to 67) -
    Gender categorical
    Units: Subjects
        Female
    		 109 109
        Male
    		 73 73
    Ethnicity
    Ethnicity for the 182 subjects eligible to take part in the study
    Units: Subjects
        Caucasian
    		 171 171
        Asian
    		 6 6
        Afro-Caribbean
    		 0 0
        Other
    		 5 5
    Child bearing
    Child bearing potential for the 73 females eligible for the study
    Units: Subjects
        Yes
    		 64 64
        No
    		 118 118
    Duration of injury (days)
    Self-reported duration of injury for the 182 patients eligible to take part in the study
    Units: Subjects
        <1
    		 0 0
        1 - 3
    		 18 18
        4 - 7
    		 27 27
        >7
    		 137 137
    Site of injury
    Location of injury reported by the 182 patients eligible to take part in the study
    Units: Subjects
        Neck
    		 14 14
        Shoulder
    		 29 29
        Upper Limb
    		 15 15
        Back
    		 45 45
        Torso
    		 0 0
        Lower Limb
    		 79 79
    Type of injury
    Type of injury sustained by the 182 participants eligible for the study
    Units: Subjects
        Sprain/strain
    		 129 129
        Muscular ache
    		 42 42
        Bruise/soft tissue
    		 11 11
    Sporting injury
    Details on whether or not the injury sustained by the 182 patients eligible for the study was a sporting injury
    Units: Subjects
        Yes
    		 104 104
        No
    		 78 78
    Baseline NRS pain score
    Pain scores at baseline for the 182 patients eligible to take part in the study
    Units: Subjects
        Six
    		 41 41
        Seven
    		 76 76
        Eight
    		 51 51
        Nine
    		 11 11
        Ten
    		 3 3
    Subject analysis sets

    Subject analysis set title
    Females
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Female participants in the study.

    Subject analysis sets values
    		 Females
    Number of subjects
    73
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Age distribtuion for the 182 participants eligible to take part in the study
    Units: years
        arithmetic mean (full range (min-max))
    Gender categorical
    Units: Subjects
        Female
        Male
    Ethnicity
    Ethnicity for the 182 subjects eligible to take part in the study
    Units: Subjects
        Caucasian
        Asian
        Afro-Caribbean
        Other
    Child bearing
    Child bearing potential for the 73 females eligible for the study
    Units: Subjects
        Yes
    64
        No
    9
    Duration of injury (days)
    Self-reported duration of injury for the 182 patients eligible to take part in the study
    Units: Subjects
        <1
        1 - 3
        4 - 7
        >7
    Site of injury
    Location of injury reported by the 182 patients eligible to take part in the study
    Units: Subjects
        Neck
        Shoulder
        Upper Limb
        Back
        Torso
        Lower Limb
    Type of injury
    Type of injury sustained by the 182 participants eligible for the study
    Units: Subjects
        Sprain/strain
        Muscular ache
        Bruise/soft tissue
    Sporting injury
    Details on whether or not the injury sustained by the 182 patients eligible for the study was a sporting injury
    Units: Subjects
        Yes
        No
    Baseline NRS pain score
    Pain scores at baseline for the 182 patients eligible to take part in the study
    Units: Subjects
        Six
        Seven
        Eight
        Nine
        Ten

    End points

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    End points reporting groups
    Reporting group title
    Ibuprofen
    Reporting group description
    		 -

    Reporting group title
    Diclofenac
    Reporting group description
    		 -

    Reporting group title
    Deep Relief
    Reporting group description
    		 -

    Subject analysis set title
    Females
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Female participants in the study.

    Primary: time to onset of significant pain relief

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    End point title
    		 time to onset of significant pain relief
    End point description
    Time to onset of significant pain relief recorded at defined intervals from gel application (t=0 min) and end of study (t=120 min) Significant pain relief defined as a 2-point drop in pain score from baseline (measured by an 11-point ordinal NRS pain scale)
    End point type
    Primary
    End point timeframe
    Time to onset of significant pain relief difference from 0 to 2 hrs
    End point values
    		 Ibuprofen Diclofenac Deep Relief
    Number of subjects analysed
    61
    61
    59
    Units: minute
        median (standard error)
    25 ± 4.875
    20 ± 3.219
    20 ± 3.189
    Statistical analysis title
    		 Equality of survival distributions (120min)
    Statistical analysis description
    Survival analysis used to test for equality of survival distributions at 120 min
    Comparison groups
    Diclofenac v Ibuprofen v Deep Relief
    Number of subjects included in analysis
    181
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 = 0.313 [1]
    Method
    		 Logrank
    Confidence interval
    Notes
    [1] - P-value was greater than the 5% significance level. Therefore, there was no evidence of a difference between the three treatment groups at 120 min
    Statistical analysis title
    		 Equality of survival distribution (30min)
    Statistical analysis description
    Survival analysis to examine the equality of the survival times for the three treatments at 30 minutes
    Comparison groups
    Diclofenac v Deep Relief v Ibuprofen
    Number of subjects included in analysis
    181
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 = 0.238 [2]
    Method
    		 Logrank
    Confidence interval
    Notes
    [2] - The p-value was greater than the 5% significance level. Therefore, there was no evidence of a difference between the three treatment groups at 30 minutes

    Secondary: Change in pain scores

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    End point title
    		 Change in pain scores
    End point description
    End point type
    Secondary
    End point timeframe
    Change in the median pain score between baseline and 2 hours
    End point values
    		 Ibuprofen Diclofenac Deep Relief
    Number of subjects analysed
    61
    61
    59
    Units: number
        number (not applicable)
    -2
    -3
    -3
    Statistical analysis title
    		 Median change in pain scores
    Comparison groups
    Ibuprofen v Diclofenac v Deep Relief
    Number of subjects included in analysis
    181
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.087 [3]
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [3] - The p-value is greater than the 5% significance level and so there is no evidence of a difference between the three groups

    Secondary: Warming sensations within the first five minutes

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    End point title
    		 Warming sensations within the first five minutes
    End point description
    End point type
    Secondary
    End point timeframe
    Number of patients experiencing warming sensations within the first five minutes
    End point values
    		 Ibuprofen Diclofenac Deep Relief
    Number of subjects analysed
    61
    61
    59
    Units: number
        Reported cooling
    5
    12
    16
    Statistical analysis title
    		 Analysis of warming
    Comparison groups
    Ibuprofen v Diclofenac v Deep Relief
    Number of subjects included in analysis
    181
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.026 [4]
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [4] - P-value less than the 5% significance level. There was evidence to suggest an association between treatment group and reported warming within the first 5 minutes

    Secondary: Cooling sensations within five minutes

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    End point title
    		 Cooling sensations within five minutes
    End point description
    End point type
    Secondary
    End point timeframe
    Number of patients reporting cooling sensations within the first 5 minutes
    End point values
    		 Ibuprofen Diclofenac Deep Relief
    Number of subjects analysed
    61
    61
    59
    Units: number
    49
    46
    48
    Statistical analysis title
    		 Cooling sensations
    Comparison groups
    Ibuprofen v Diclofenac v Deep Relief
    Number of subjects included in analysis
    181
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.692 [5]
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [5] - Since the p-value is greater than 0.05, there is no evidence of an association between treatment group and cooling within the first five minutes

    Secondary: Functional impairment at 2 hours

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    End point title
    		 Functional impairment at 2 hours
    End point description
    End point type
    Secondary
    End point timeframe
    Changes in functional impairment between baseline and 2 hours
    End point values
    		 Ibuprofen Diclofenac Deep Relief
    Number of subjects analysed
    61
    61
    59
    Units: number
        number (not applicable)
    -2
    -2
    -2
    Statistical analysis title
    		 Analysis of changes to functional impairment
    Comparison groups
    Ibuprofen v Diclofenac v Deep Relief
    Number of subjects included in analysis
    181
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.889 [6]
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [6] - At the 5% significance level there was no evidence of a difference in the change in functional impairment scores among the three treatment groups between baseline and 2 hours

    Secondary: Assessment of general/global pain relief at 2 hours

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    End point title
    		 Assessment of general/global pain relief at 2 hours
    End point description
    End point type
    Secondary
    End point timeframe
    Between baseline and 2 hours
    End point values
    		 Ibuprofen Diclofenac Deep Relief
    Number of subjects analysed
    61
    61
    59
    Units: number
        median (full range (min-max))
    5 (1 to 7)
    4 (1 to 7)
    4 (1 to 6)
    Statistical analysis title
    		 Global pain relief
    Statistical analysis description
    Global pain relief was coded to a 7 - point scale and the median values compared between the three groups. Levels: No relief, slight relief, mild relief, moderate relief, considerable relief, almost complete relief and complete relief
    Comparison groups
    Ibuprofen v Diclofenac v Deep Relief
    Number of subjects included in analysis
    181
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.006 [7]
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [7] - P-value was less than 5% significance level so there was evidence to suggest that the general pain relief reported at 2 hours differed between the three treatment groups

    Post-hoc: Proportions achieving significant pain relief

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    End point title
    		 Proportions achieving significant pain relief
    End point description
    End point type
    Post-hoc
    End point timeframe
    Differences between the proportion of people achieving significant pain relief at 30 minutes
    End point values
    		 Ibuprofen Diclofenac Deep Relief
    Number of subjects analysed
    61
    61
    59
    Units: number
        number (not applicable)
    0.557337
    0.655738
    0.711864
    Statistical analysis title
    		 Test for two proportions
    Comparison groups
    Ibuprofen v Deep Relief
    Number of subjects included in analysis
    120
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 = 0.075 [8]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [8] - P-value was greater than the 5% significance level. There was no evidence to suggest that the proportion on Ibuprofen who achieved significant pain relief was different to the proportion on Deep Relief who achieved significant pain relief
    Statistical analysis title
    		 Diclofenac vs Deep Relief
    Comparison groups
    Diclofenac v Deep Relief
    Number of subjects included in analysis
    120
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 = 0.508 [9]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [9] - P-value is greater than 5% significance level. There is no evidence to suggest that the proportion on Deep relief who achieved significant pain relief was different to the proportion on Diclofenac who achieved significant pain relief

    Post-hoc: Number of patients achieving significant pain relief

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    End point title
    		 Number of patients achieving significant pain relief
    End point description
    End point type
    Post-hoc
    End point timeframe
    Number of people achieving significant pain relief at time points 1, 2.5, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 40, 50, 60, 75, 90, 105, 120
    End point values
    		 Ibuprofen Diclofenac Deep Relief
    Number of subjects analysed
    61
    61
    59
    Units: number
        1.0
    1
    4
    1
        2.5
    5
    6
    3
        5.0
    6
    10
    9
        7.5
    12
    13
    15
        10
    17
    20
    23
        12.5
    20
    26
    26
        15
    22
    30
    29
        20
    29
    35
    32
        25
    32
    39
    41
        30
    34
    40
    42
        40
    40
    44
    45
        50
    43
    47
    48
        60
    44
    48
    48
        75
    46
    48
    50
        90
    47
    48
    51
        105
    48
    49
    52
        120
    50
    50
    53
    No statistical analyses for this end point

    Post-hoc: Number reporting cooling at 2 hours

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    End point title
    		 Number reporting cooling at 2 hours
    End point description
    End point type
    Post-hoc
    End point timeframe
    2 hours (120 minutes)
    End point values
    		 Ibuprofen Diclofenac Deep Relief
    Number of subjects analysed
    61
    61
    59
    Units: number
        Yes
    9
    10
    27
    Statistical analysis title
    		 Difference between number reporting cooling at 2 h
    Comparison groups
    Ibuprofen v Diclofenac v Deep Relief
    Number of subjects included in analysis
    181
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 < 0.001 [10]
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [10] - The p-value is less than 5% significance level so there is evidence to suggest significantly more people in the deep relief group reported cooling (46%) than in the other groups (16% and 15%)

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Patients were asked if they had any untoward signs or symptoms (not including symptoms of their injury) at the pre-dose time-point, at the end of the two hour assessment period and at the follow up (up to 72 hours after leaving the assessment centre).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Diclofenac group
    Reporting group description
    		 Subjects who were treated with diclofenac gel.

    Reporting group title
    Ibuprofen
    Reporting group description
    		 subjects who were exposed to ibuprofen gel

    Reporting group title
    Deep Relief
    Reporting group description
    		 Subjects who were exposed to Deep Relief gel.

    Serious adverse events
    		 Diclofenac group Ibuprofen Deep Relief
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Surgical and medical procedures
    Fracture treatment
    Additional description: The event was unrelated to the study medication- diclofenac group.
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Diclofenac group Ibuprofen Deep Relief
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 61 (4.92%)
    1 / 61 (1.64%)
    1 / 59 (1.69%)
    Nervous system disorders
    Head discomfort
    Additional description: Pressure on forehead. Considered not related to study medication.
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Feeling hot
    Additional description: Warming sensation on the neck. Considered unlikely to be related to the study medication.
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Application site reaction
    Additional description: Red itchy skin where gel applied. Mild severity. Considered related to study medication.
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Peripheral swelling
    Additional description: Swelling to feet and ankles. Mild severity. Considered not related to study medication.
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 61 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Pyrexia
    Additional description: Feeling high temperature. Mild severity. Considered not related to study medication.
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 61 (1.64%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Night sweats
    Additional description: Considered not related to study medication
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 61 (1.64%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal discomfort
    Additional description: Pressure at the base of back. Considered not related to study medication.
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 61 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    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
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    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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