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    Clinical Trial Results:
    A randomized double blind placebo controlled multicenter study to assess the efficacy and tolerability of tolperisone as add on treatment with standardized NSAID of acute non specific low back pain.

    Summary
    EudraCT number
    		 2021-006042-13
    Trial protocol
    		 HU  
    Global end of trial date
    03 Feb 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Feb 2024
    First version publication date
    18 Feb 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MEDI-TOLP-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MEDITOP Pharmaceutical Ltd.
    Sponsor organisation address
    Ady Endre utca 1., Pilisborosjenő, Hungary, 2097
    Public contact
    Dr. Orsolya Czifra Phone: (+36) 30 789 20 85 orsolya.czifra@meditop.hu info@meditop.hu, Medical Director, 36 307892085, info@meditop.hu
    Scientific contact
    Dr. Orsolya Czifra, Medical Director, 36 307892085, orsolya.czifra@meditop.hu
    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 Dec 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Nov 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Feb 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether tolperisone, when administered with standardized NSAID treatment to patients with acute non-specific low back pain is effective in reducing pain.
    Protection of trial subjects
    This study was conducted in accordance with the protocol and with the following: • Consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines • Applicable ICH Good Clinical Practice (GCP) Guidelines • Applicable laws and regulations The investigator or his/her representative explained the nature of the study to the participant and answered all questions regarding the study during the screening visit. Patients were handed over a detailed Information Leaflet (PIL) about the study. Participants were informed that their participation is voluntary. Participants were required to sign a statement of informed consent ICF approved by the Central Ethical Committee (CEC). The patients’ medical record includes a statement that written informed consent was obtained before the participant was enrolled in the study and the date the written consent was obtained. The authorized physician obtaining the informed consent must also sign the ICF. Participants were consented to the most current version of the ICF(s) during their participation in the study.
    Background therapy
    		 Every enrolled patient received standardized oral ibuprofen treatment (ie. Algoflex Rapid 3x400 mg daily for 14 days).
    Evidence for comparator
    		 Placebo was used as a comparator during the study.
    Actual start date of recruitment
    06 Apr 2022
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 3 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Hungary: 331
    Worldwide total number of subjects
    331
    EEA total number of subjects
    331
    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)
    331
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Male and female patients between the ages 18-55 years with muscle spasm associated with acute non-specific low back pain were enrolled in the study.

    Pre-assignment
    Screening details
    		 All screening evaluations were completed and reviewed to confirm that potential participants meet all eligibility criteria. The investigators maintained a screening log to record details of all participants screened and to confirm eligibility or record reasons for screening failure, as applicable. Screening and randomisation were completed on the

    Period 1
    Period 1 title
    Treatment
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    This was a double blind, placebo controlled study, both the investigators and patients were blind to study treatment. Patients received either placebo or active (matching) per os treatment. Unblinding for medical emergency in which the knowledge of the specific blinded study treatment would affect the immediate management of the participant’s condition was available for all investigators.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 Patients received 3x150 mg tolperison (IMP) and a standard 3x400 mg ibuprophen for 14 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tolperisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    3x1 tablets/day. 1 tablet contained 150 mg tolperisone. To be consumed after meal with a glass of water. Every enrolled patient received standardized oral ibuprofen treatment (ie. Algoflex Rapid 3x400 mg daily for 14 days). In addition to the standardized ibuprofen baseline therapy the patients received additional ibuprofen as rescue medication. Maximum dose of ibuprofen was not to exceed 2400 mg/day (3x800 mg).

    Arm title
    		 Placebo
    Arm description
    		 Patients received 3x150 mg placebo (IMP) and a standard 3x400 mg ibuprophen for 14 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received 3x150 mg placebo (IMP) and a standard 3x400 mg ibuprophen for 14 days. Medication was to be taken after meal, with a glass of water. Every patient received standardized ibuprophen therapy (3*400 mg) and additional ibuprophen as rescue medication (up to 3*800 mg maximum).

    Number of subjects in period 1
    		Active Placebo
    Started
    165
    166
    Completed
    164
    166
    Not completed
    1
    0
         Lost to follow-up
    1
    -
    Period 2
    Period 2 title
    Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Treatment blinding was kept until database lock.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Active Placebo
    Started
    164
    166
    Completed
    164
    165
    Not completed
    0
    1
         Sponsor's decision
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Patients received 3x150 mg tolperison (IMP) and a standard 3x400 mg ibuprophen for 14 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Patients received 3x150 mg placebo (IMP) and a standard 3x400 mg ibuprophen for 14 days.

    Reporting group values
    		 Active Placebo Total
    Number of subjects
    		 165 166 331
    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 ranged from 18 to 66 years.
    Units: years
        arithmetic mean (standard deviation)
    		 40.6 ( 10.4 ) 40.8 ( 10.3 ) -
    Gender categorical
    Male/Female
    Units: Subjects
        Female
    		 104 82 186
        Male
    		 61 84 145
    Spasticity
    Muscle spasticity of the low back pain region assessed during physical examination by the investigator.
    Units: Subjects
        0=no spasticity
    		 0 0 0
        1=slight muscle spasm
    		 0 0 0
        2=moderate muscle spasm
    		 140 142 282
        3=severe muscle spasm
    		 25 24 49
    Height
    height at baseline
    Units: cm
        arithmetic mean (standard deviation)
    		 170.9 ( 9.6 ) 171.7 ( 9.5 ) -
    Weight
    Patient body weight at baseline
    Units: kg
        arithmetic mean (standard deviation)
    		 78.5 ( 16 ) 80.7 ( 16.1 ) -
    BMI
    Body Mass Index
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 26.7 ( 4.2 ) 27.2 ( 4.3 ) -

    End points

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    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Patients received 3x150 mg tolperison (IMP) and a standard 3x400 mg ibuprophen for 14 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Patients received 3x150 mg placebo (IMP) and a standard 3x400 mg ibuprophen for 14 days.
    Reporting group title
    Active
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population is defined as all subjects who were exposed to study treatment, regardless of the duration of therapy.

    Subject analysis set title
    Full analysis set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients in Safety Population who have primary efficacy data.

    Subject analysis set title
    Per Protocol Set (PPS)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All FAS patients who finished the study according to the protocol and had no major protocol deviations. In case of efficacy analyses the definition of estimands include the exact definition of the study population that is used for the given analysis.

    Primary: Change in VAS pain score

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    End point title
    		 Change in VAS pain score
    End point description
    The change in pain visual analogue scale (VAS) score (pain on movement) from Baseline to Day 5.
    End point type
    Primary
    End point timeframe
    Baseline to Day 5
    End point values
    		 Active Placebo Full analysis set (FAS)
    Number of subjects analysed
    164
    166
    330
    Units: cm
        arithmetic mean (standard deviation)
    -2.34 ( 1.903 )
    -2.44 ( 1.963 )
    -2.39 ( 1.931 )
    Statistical analysis title
    		 Mixed model comparisons – VAS pain on movement up
    Statistical analysis description
    Pain on movement Mixed model results of the treatment difference Active vs Placebo While on treatment strategy
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    330
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.3371 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 LS mean
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.68
         upper limit
    		 0.08
    Variability estimate
    Standard deviation
    Dispersion value
    1.931
    Notes
    [1] - Mixed-effect model with repeated measures (MMRM) approach. All post-baseline data available at Day 3 and Day 5 were used until the start of the use of any prohibited medications. Missing data was accounted for by the MMRM model. Fixed effects: treatment, time point, treatment by time point interaction; and baseline VAS value. The point estimate for the least-squares mean of the treatment difference at Day 5 and the corresponding 95% confidence interval and p-value were summarized.
    [2] - Treatment*day

    Secondary: FFD

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    End point title
    		 FFD
    End point description
    The change in Finger-to-Floor Distance (FFD) from Baseline throughout the study (Day 3, 5, 7 and 14).
    End point type
    Secondary
    End point timeframe
    Baselin to Day 14.
    End point values
    		 Active Placebo Full analysis set (FAS)
    Number of subjects analysed
    163
    165
    328
    Units: cm
        arithmetic mean (standard deviation)
    -11.03 ( 13.008 )
    -10.44 ( 10.727 )
    -10.74 ( 11.901 )
    No statistical analyses for this end point

    Secondary: Lumbar Spine Side Flexion test

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    End point title
    		 Lumbar Spine Side Flexion test
    End point description
    The change in the result of Lumbar Spine Side Flexion test from Baseline throughout the study (Day 3, 5, 7 and 14).
    End point type
    Secondary
    End point timeframe
    From Baseline to Day 14.
    End point values
    		 Active Placebo Full analysis set (FAS)
    Number of subjects analysed
    163
    165
    328
    Units: cm
        arithmetic mean (standard deviation)
    -6.45 ( 6.732 )
    -6.02 ( 5.801 )
    -6.23 ( 6.275 )
    No statistical analyses for this end point

    Secondary: RMDQ

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    End point title
    		 RMDQ
    End point description
    The change in Roland-Morris Disability Questionnaire (RMDQ) score from Baseline throughout the study (Day 3, 5, 7 and 14).
    End point type
    Secondary
    End point timeframe
    From Baseline to Day 14
    End point values
    		 Active Placebo Full analysis set (FAS)
    Number of subjects analysed
    164
    166
    330
    Units: points
        arithmetic mean (standard deviation)
    -5.17 ( 4.295 )
    -5.63 ( 3.918 )
    -5.4 ( 4.11 )
    No statistical analyses for this end point

    Secondary: Pain VAS diary

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    End point title
    		 Pain VAS diary
    End point description
    The change in pain VAS scores (pain at rest) from Baseline throughout the study assessed by the patient daily in the Patient Diary.
    End point type
    Secondary
    End point timeframe
    From Baseline to Day 14
    End point values
    		 Active Placebo Full analysis set (FAS)
    Number of subjects analysed
    148
    155
    303
    Units: cm
        arithmetic mean (standard deviation)
    -3.9 ( 2.562 )
    -3.95 ( 2.709 )
    -3.93 ( 2.633 )
    No statistical analyses for this end point

    Secondary: Sum of Pain Intensity Differences

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    End point title
    		 Sum of Pain Intensity Differences
    End point description
    The Sum of Pain Intensity Differences (SPID): the area under the time-analgesic effect curve for pain intensity from baseline to Day 3, 5, 7 and 14.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 14
    End point values
    		 Active Placebo Full analysis set (FAS)
    Number of subjects analysed
    163
    165
    328
    Units: cm
        arithmetic mean (standard deviation)
    79.09 ( 21.785 )
    74.99 ( 24.448 )
    77.03 ( 23.219 )
    No statistical analyses for this end point

    Secondary: Rescue medication

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    End point title
    		 Rescue medication
    End point description
    The amount of rescue medication taken by the patient and recorded in the patient diary.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 14
    End point values
    		 Active Placebo Full analysis set (FAS)
    Number of subjects analysed
    164
    166
    330
    Units: tablet
        arithmetic mean (standard deviation)
    3.64 ( 5.85 )
    3.22 ( 7.081 )
    3.43 ( 6.492 )
    No statistical analyses for this end point

    Secondary: Physician’s global assessment of the treatment

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    End point title
    		 Physician’s global assessment of the treatment
    End point description
    The value of physician’s global assessment of the treatment (PhGA) throughout the study (Day 3, 5, 7 and 14).
    End point type
    Secondary
    End point timeframe
    Baseline to DAy 14
    End point values
    		 Active Placebo Full analysis set (FAS)
    Number of subjects analysed
    164
    166
    330
    Units: points
        poor
    9
    6
    15
        fair
    17
    21
    38
        good
    60
    52
    112
        very good
    58
    60
    118
        excellent
    18
    26
    44
    No statistical analyses for this end point

    Secondary: Patient’s Global Impression of improvement

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    End point title
    		 Patient’s Global Impression of improvement
    End point description
    The value of Patient’s Global Impression of improvement (PGIC-I)
    End point type
    Secondary
    End point timeframe
    Baseline to Day 14
    End point values
    		 Active Placebo Full analysis set (FAS)
    Number of subjects analysed
    164
    166
    330
    Units: patients
        poor
    9
    4
    13
        fair
    19
    23
    42
        good
    46
    51
    97
        very good
    67
    57
    124
        excellent
    21
    30
    51
    No statistical analyses for this end point

    Secondary: Responder rate

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    End point title
    		 Responder rate
    End point description
    Responder rate at Day 3, 5, 7 and 14. A patient is considered responder if the absolute change in VAS score from baseline is >=3.5 cm.
    End point type
    Secondary
    End point timeframe
    Day 3-14
    End point values
    		 Active Placebo Full analysis set (FAS)
    Number of subjects analysed
    165
    166
    331
    Units: patients
        responder
    116
    120
    236
        not-responder
    47
    45
    92
    No statistical analyses for this end point

    Other pre-specified: EQ-5D

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    End point title
    		 EQ-5D
    End point description
    The change in quality of life (EQ-5D) scores from Baseline throughout the study (Day 3, 5, 7 and 14).
    End point type
    Other pre-specified
    End point timeframe
    Baseline to Day 14
    End point values
    		 Active Placebo Full analysis set (FAS)
    Number of subjects analysed
    163
    165
    328
    Units: points
        arithmetic mean (standard deviation)
    6.83 ( 1.884 )
    6.73 ( 1.997 )
    6.78 ( 1.94 )
    No statistical analyses for this end point

    Other pre-specified: Days of absenteeism

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    End point title
    		 Days of absenteeism
    End point description
    Days of absenteeism from work from Baseline to Day 14.
    End point type
    Other pre-specified
    End point timeframe
    Baseline to Day 14
    End point values
    		 Active Placebo Full analysis set (FAS)
    Number of subjects analysed
    149
    144
    293
    Units: days
    26
    311
    57
    No statistical analyses for this end point

    Other pre-specified: Number of recurrences

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    End point title
    		 Number of recurrences
    End point description
    Number of recurrences until the 3 months follow-up visit.
    End point type
    Other pre-specified
    End point timeframe
    3 months
    End point values
    		 Active Placebo Full analysis set (FAS)
    Number of subjects analysed
    164
    165
    329
    Units: number
    24
    20
    44
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All SAEs and AEs were collected from the start of treatment until the follow-up (D21) visit.
    Adverse event reporting additional description
    The following events were considered AESI and immediately reported to the Sponsor (same procedure as SAE): Hypersensitivity reactions (regardless of severity) • Any observed or reported hypersensitivity reaction will be closely monitored by the Investigators until resolution.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26
    Reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Patients receiving Tolperisone treatment

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Active Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 165 (0.00%)
    0 / 166 (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: 0.05%
    Non-serious adverse events
    		 Active Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 165 (16.97%)
    23 / 166 (13.86%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 165 (0.61%)
    1 / 166 (0.60%)
         occurrences all number
    1
    1
    Surgical and medical procedures
    Ear operation
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 165 (1.21%)
    1 / 166 (0.60%)
         occurrences all number
    2
    1
    Blood bilirubin increased
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences all number
    1
    0
    Blood glucose increased
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences all number
    1
    0
    Blood urine present
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences all number
    0
    1
    Glomerular filtration rate decreased
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences all number
    0
    1
    Platelet count decreased
         subjects affected / exposed
    1 / 165 (0.61%)
    1 / 166 (0.60%)
         occurrences all number
    1
    1
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences all number
    0
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences all number
    1
    0
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    5 / 165 (3.03%)
    4 / 166 (2.41%)
         occurrences all number
    5
    4
    Nerve compression
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences all number
    1
    0
    Somnolence
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences all number
    1
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 165 (1.21%)
    0 / 166 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    2 / 165 (1.21%)
    3 / 166 (1.81%)
         occurrences all number
    2
    3
    Diarrhoea
         subjects affected / exposed
    1 / 165 (0.61%)
    4 / 166 (2.41%)
         occurrences all number
    1
    4
    Dry mouth
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    3 / 165 (1.82%)
    1 / 166 (0.60%)
         occurrences all number
    3
    1
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 165 (0.61%)
    1 / 166 (0.60%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Dermal cyst
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 165 (1.82%)
    3 / 166 (1.81%)
         occurrences all number
    3
    3
    Muscle spasms
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences all number
    0
    1
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 165 (0.61%)
    1 / 166 (0.60%)
         occurrences all number
    1
    1
    Herpes zoster
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 165 (1.21%)
    1 / 166 (0.60%)
         occurrences all number
    2
    1
    Otitis externa
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences all number
    0
    1
    Tonsillitis
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 166 (0.60%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 166 (0.00%)
         occurrences all number
    1
    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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