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    Clinical Trial Results:
    ED95 doses of commonly used local anaesthetic agents for ultrasound guided brachial plexus blocks

    Summary
    EudraCT number
    		 2010-018466-22
    Trial protocol
    		 GB  
    Global end of trial date
    14 May 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jul 2019
    First version publication date
    20 Jul 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AN09/9220
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Leeds
    Sponsor organisation address
    Woodhouse lane, Leeds, United Kingdom,
    Public contact
    Dr Anurag Vats, University of Leeds, anuragvats@nhs.net
    Scientific contact
    Dr Anurag Vats, University of Leeds, anuragvats@nhs.net
    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
    30 May 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 May 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    14 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To find out the doses (of the most commonly used local anaesthetic agents) that have 95% chance of success for ultrasound guided brachial plexus blocks in patients scheduled for upper limb surgery. (Ultrasound guided brachial plexus block refers to injection of the local anaesthetic drug around the nerves supplying sensation to the shoulder and the arm under ultrasound guidance)
    Protection of trial subjects
    The study was conducted according to the Good Clinical Practice (GCP) guidelines, and was regularly audited/monitored by the sponsor. All investigators connected to the study were GCP trained. All patients provided a written informed consent after considering the research information, and discussion with a GCP trained investigator. The study was approved by the local research ethics committee including amendments. We made provisions for securing safeguards of confidentiality of research data.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Nov 2011
    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: 200
    Worldwide total number of subjects
    200
    EEA total number of subjects
    200
    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)
    146
    From 65 to 84 years
    51
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 Inclusion criteria: ASA 1-3 patients, Age >18 years, Patients of both sexes, Patients undergoing upper limb and shoulder surgery Exclusion criteria: ASA> 3, Age <18 years, Allergy to local anaesthetic agent, Unable to give written informed consent, Body Mass Index >40, Pregnant woman. All patient were recruited at a single site in the trial period

    Pre-assignment
    Screening details
    		 Patients were provided patient information sheet in the pre-assessment clinic, acute care admission ward for arm,forearm and hand injuries and/or by post as soon as they were listed for an upper limb surgery on a theatre list managed by the designated operator. (As agreed with the local ethics committee. )

    Pre-assignment period milestones
    Number of subjects started
    		 200
    Number of subjects completed
    		 200

    Period 1
    Period 1 title
    Main trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject, Assessor
    Blinding implementation details
    The patient, the investigator performing the nerve block (the operator) and the investigator assessing it (the assessor) were blinded to the IMP type and dose. The dose of respective IMP was divided equally in multiple syringes which were covered completely with an opaque tape to blind the investigator. The assessor was not present at the time of administration of local anaesthetic. This method of blinding has been used in our institute in previous studies and has proven to be successful.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Levo-bupivacaine 0.25% for interscalene brachial plexus block.
    Arm description
    		 The patients recruited in this arm of the study were listed for a shoulder surgery and had an interscalene brachial plexus block sited under a general anaesthetic as per the protocol. The interscalene arm of the study is a dose-finding trial for 0.25% levo-bupivacaine and is not randomised.Efficacy of the block was assessed by VAPS pain scores at 15, 30, 60 and 120 minute intervals after the patient comes to recovery (PACU), where 0 mm on a 100 mm scale is no pain and 100 mm is the worst imaginable pain.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Levo-bupivacaine 0.25%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Perineural use
    Dosage and administration details
    The brachial plexus block was performed once the patient was in the anaesthetic room by the designated investigator (operator) using direct ultrasound guidance, under a general anaesthetic as per the protocol. The interscalene part of the brachial plexus was visualised using a Sonosite S Nerve ultrasound machine. The nerve block needle was passed under ultrasound guidance so that its tip lies adjacent to the brachial plexus. After negative aspiration from the needle the study dose of 0.25% levo-bupivacaine was injected. This was done under ultrasound visualisation to ensure correct location of the needle is maintained and the spread of drug is uniform.The first dose used was 30 ml of levo-bupivacaine 0.25%, which is closest to the ED95. Subsequent doses were based on continual reassessment method as per the guidance of statistical support team with maximum ceiling of 50 ml. We have used the supply of IMP available in our hospital provided by a MA holding company in the country.

    Arm title
    		 Lidocaine 1% with adrenaline 1:200,000 and Prilocaine 1% for s
    Arm description
    		 The patients recruited in this arm of the study were listed for an elbow, forearm or hand surgery. Consenting and eligible patients were randomised to either receive prilocaine 1% or lidocaine 1% with adrenaline (1:200,000) for an ultrasound guided supraclavicular block. Efficacy of the block was assessed at 10-minute intervals after siting the block, for up to 30 minutes at the sensory dermatomes of the median, ulnar, radial and musculocutaneous nerves in the upper limb to cold (i.e. at 10, 20, 30, minutes after the injection is finished).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lidocaine 1% with adrenaline (Epinephrine) 1:200,000 and Prilocaine 1 %
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Perineural use
    Dosage and administration details
    The brachial plexus block was performed once in the anaesthetic room by a designated investigator under direct ultrasound guidance and standard monitoring . The overlying skin was infiltrated with 1% Lidocaine and a nerve block needle passed under ultrasound guidance so that its tip lies adjacent to the brachial plexus. After negative aspiration from the needle the study dose of lidocaine 1% with adrenaline (1:200,000) or prilocaine 1% was injected as per the randomisation. This was done under direct ultrasound visualisation to ensure correct location of the needle is maintained.The starting dose in each group (lidocaine 1% with adrenaline or prilocaine 1%) was 30mls, which is the closest to the estimated ED95. Subsequent doses were based on continual reassessment method as per the guidance of statistical support team with maximum ceiling of 40 ml for each IMP. We have used the supply of IMP available in our hospital provided by a MA holding company in the country.

    Arm title
    		 Lidocaine 1% and lidocaine 2% each with adrenaline 1:200,000 f
    Arm description
    		 The patients recruited in this arm of the study were listed for an elbow, forearm or hand surgery. Consenting and eligible patients were randomised to receive either lidocaine 1% with adrenaline (1:200,000) or lidocaine 2% with adrenaline (1:200,000) for an ultrasound guided axillary block under a local anaesthetic skin infilteration. Efficacy of the block was assessed at 10-minute intervals after siting the block, for up to 30 minutes at the sensory dermatomes of the median, ulnar, radial and musculocutaneous nerves in the upper limb to cold (i.e. at 10, 20, 30, minutes after the injection is finished).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lidocaine 1% and lidocaine 2% each with adrenaline 1:200,000
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Perineural use
    Dosage and administration details
    The brachial plexus block was performed once in the anaesthetic room by a designated investigator under standard monitoring. The four terminal branches of brachial plexus were visualized using an ultrasound machine. The overlying skin was infiltrated with 1% Lidocaine and a nerve block needle was passed under ultrasound guidance so that its tip lies adjacent to the branches of the brachial plexus. After negative aspiration from the needle the study dose of lidocaine 1% or lidocaine 2% [each with adrenaline (1:200,000)] was injected as per the randomisation. This was done under direct ultrasound visualisation to ensure correct location of the needle is maintained. The first dose used was 15 ml for the lidocaine 2% with adr group and 30 ml for the lidocaine 1% with adr group, which is closest to the estimated ED95. Subsequent doses were based on continual reassessment method as per the guidance of statistical support team. We used the standard supply of IMP available in our hospital.

    Number of subjects in period 1
    		Levo-bupivacaine 0.25% for interscalene brachial plexus block. Lidocaine 1% with adrenaline 1:200,000 and Prilocaine 1% for s Lidocaine 1% and lidocaine 2% each with adrenaline 1:200,000 f
    Started
    46
    73
    81
    Completed
    46
    73
    81

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Levo-bupivacaine 0.25% for interscalene brachial plexus block.
    Reporting group description
    		 The patients recruited in this arm of the study were listed for a shoulder surgery and had an interscalene brachial plexus block sited under a general anaesthetic as per the protocol. The interscalene arm of the study is a dose-finding trial for 0.25% levo-bupivacaine and is not randomised.Efficacy of the block was assessed by VAPS pain scores at 15, 30, 60 and 120 minute intervals after the patient comes to recovery (PACU), where 0 mm on a 100 mm scale is no pain and 100 mm is the worst imaginable pain.

    Reporting group title
    Lidocaine 1% with adrenaline 1:200,000 and Prilocaine 1% for s
    Reporting group description
    		 The patients recruited in this arm of the study were listed for an elbow, forearm or hand surgery. Consenting and eligible patients were randomised to either receive prilocaine 1% or lidocaine 1% with adrenaline (1:200,000) for an ultrasound guided supraclavicular block. Efficacy of the block was assessed at 10-minute intervals after siting the block, for up to 30 minutes at the sensory dermatomes of the median, ulnar, radial and musculocutaneous nerves in the upper limb to cold (i.e. at 10, 20, 30, minutes after the injection is finished).

    Reporting group title
    Lidocaine 1% and lidocaine 2% each with adrenaline 1:200,000 f
    Reporting group description
    		 The patients recruited in this arm of the study were listed for an elbow, forearm or hand surgery. Consenting and eligible patients were randomised to receive either lidocaine 1% with adrenaline (1:200,000) or lidocaine 2% with adrenaline (1:200,000) for an ultrasound guided axillary block under a local anaesthetic skin infilteration. Efficacy of the block was assessed at 10-minute intervals after siting the block, for up to 30 minutes at the sensory dermatomes of the median, ulnar, radial and musculocutaneous nerves in the upper limb to cold (i.e. at 10, 20, 30, minutes after the injection is finished).

    Reporting group values
    		 Levo-bupivacaine 0.25% for interscalene brachial plexus block. Lidocaine 1% with adrenaline 1:200,000 and Prilocaine 1% for s Lidocaine 1% and lidocaine 2% each with adrenaline 1:200,000 f Total
    Number of subjects
    		 46 73 81 200
    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
    Subject population for all three arms were ASA grade I to III, both male and female, attending for upper limb surgery. We recorded patient's date of birth for age calculations.
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 54.5 (40.25 to 65) 60 (50 to 69) 42 (25 to 59) -
    Gender categorical
    Units: Subjects
        Female
    		 16 44 26 86
        Male
    		 30 29 55 114

    End points

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    End points reporting groups
    Reporting group title
    Levo-bupivacaine 0.25% for interscalene brachial plexus block.
    Reporting group description
    		 The patients recruited in this arm of the study were listed for a shoulder surgery and had an interscalene brachial plexus block sited under a general anaesthetic as per the protocol. The interscalene arm of the study is a dose-finding trial for 0.25% levo-bupivacaine and is not randomised.Efficacy of the block was assessed by VAPS pain scores at 15, 30, 60 and 120 minute intervals after the patient comes to recovery (PACU), where 0 mm on a 100 mm scale is no pain and 100 mm is the worst imaginable pain.

    Reporting group title
    Lidocaine 1% with adrenaline 1:200,000 and Prilocaine 1% for s
    Reporting group description
    		 The patients recruited in this arm of the study were listed for an elbow, forearm or hand surgery. Consenting and eligible patients were randomised to either receive prilocaine 1% or lidocaine 1% with adrenaline (1:200,000) for an ultrasound guided supraclavicular block. Efficacy of the block was assessed at 10-minute intervals after siting the block, for up to 30 minutes at the sensory dermatomes of the median, ulnar, radial and musculocutaneous nerves in the upper limb to cold (i.e. at 10, 20, 30, minutes after the injection is finished).

    Reporting group title
    Lidocaine 1% and lidocaine 2% each with adrenaline 1:200,000 f
    Reporting group description
    		 The patients recruited in this arm of the study were listed for an elbow, forearm or hand surgery. Consenting and eligible patients were randomised to receive either lidocaine 1% with adrenaline (1:200,000) or lidocaine 2% with adrenaline (1:200,000) for an ultrasound guided axillary block under a local anaesthetic skin infilteration. Efficacy of the block was assessed at 10-minute intervals after siting the block, for up to 30 minutes at the sensory dermatomes of the median, ulnar, radial and musculocutaneous nerves in the upper limb to cold (i.e. at 10, 20, 30, minutes after the injection is finished).

    Primary: Success of a block

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    End point title
    		 Success of a block
    End point description
    Successful block: Supraclavicular and Axillary approaches: Absence of sensation to cold and pin prick at the sensory dermatomes of the median, ulnar, radial and musculocutaneous nerves in the upper limb, 30 min after the block. Interscalene approach: VAPS (scale from 0-100) in the operated shoulder of < 10 mm, at 120 minutes after admission to the post-anaesthesia care unit (PACU).
    End point type
    Primary
    End point timeframe
    For supraclavicular and axillary block: 10 minutes, 20 minutes and 30 minutes after the injection of a local anaesthetic ; For interscalene block: 15 minutes, 30 minutes, 60 minutes and 120 minutes after a patient arrives in the recovery room
    End point values
    		 Levo-bupivacaine 0.25% for interscalene brachial plexus block. Lidocaine 1% with adrenaline 1:200,000 and Prilocaine 1% for s Lidocaine 1% and lidocaine 2% each with adrenaline 1:200,000 f
    Number of subjects analysed
    46
    70 [1]
    80 [2]
    Units: numbers
        Successful block
    41
    52
    66
        Failed block
    5
    19
    14
        Technical failure
    0
    3
    1
    Notes
    [1] - As per the protocol
    [2] - as per the protocol
    Statistical analysis title
    		 ED95 estimates using the CRM (interscalene)
    Statistical analysis description
    We set explicit inclusion and exclusion criteria, study stopping criteria and had clearly defined end points for patients recruited in the trial. The initial sample size of 40 patients to get reliable estimates of the ED95 dose was estimated after a sensitivity analysis. The modified CRM is a sequential dose allocation method based on the Bayesian analysis that uses aggregated published data, doses and responses of previous studies as well as the present allocated doses to advise further doses
    Comparison groups
    Lidocaine 1% with adrenaline 1:200,000 and Prilocaine 1% for s v Levo-bupivacaine 0.25% for interscalene brachial plexus block.
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0 [4]
    Method
    		 CRM
    Parameter type
    		 adaptive
    Point estimate
    95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5
         upper limit
    		 99
    Variability estimate
    Standard deviation
    Dispersion value
    0
    Notes
    [3] - The ED95 dose estimate was determined using the modified CRM method (one parameter model).The posterior response probability of each dose level was re-estimated after inclusion of each cohort (2 patients). The dose allocated to each new cohort of patients was the dose level with the updated posterior response probability closest to 0.95. The dose-finding allocation was performed using R software version 3.2.2 (R cran). The study was stopped when the best estimate of ED95 was achieved.
    [4] - Not applicable
    Statistical analysis title
    		 ED95 estimates using the CRM ( supraclavicular)
    Statistical analysis description
    We set explicit inclusion/exclusion criteria, study stopping criteria and had clearly defined end points for patients recruited in the trial. The total sample size of 40 patients/arm to get reliable estimates of the ED95 dose was estimated after a sensitivity analysis. The modified CRM is a sequential dose allocation method based on the Bayesian analysis that uses aggregated published data, doses and responses of previous studies as well as the present allocated doses to advise further doses.
    Comparison groups
    Lidocaine 1% with adrenaline 1:200,000 and Prilocaine 1% for s v Lidocaine 1% and lidocaine 2% each with adrenaline 1:200,000 f
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0 [6]
    Method
    		 CRM
    Parameter type
    		 adaptive
    Point estimate
    95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5
         upper limit
    		 99
    Variability estimate
    Standard error of the mean
    Dispersion value
    0
    Notes
    [5] - The ED95 dose was determined using the modified CRM method (one parameter model).The posterior response probability of each dose level was re-estimated after inclusion of each cohort (2 patients). The dose allocated to each new cohort of patients was the dose level with the updated posterior response probability closest to 0.95. The dose-finding allocation was performed using R software version 3.2.2 (R cran). The study was stopped when study stopping criteria were met for respective study arms.
    [6] - not applicable
    Statistical analysis title
    		 ED95 estimates using the CRM (Axillary)
    Statistical analysis description
    We set explicit inclusion/exclusion criteria, study stopping criteria and had clearly defined end points for patients recruited in the trial. The initial sample size of 40 patients/arm to get reliable estimates of the ED95 dose was estimated after a sensitivity analysis. The modified CRM is a sequential dose allocation method based on the Bayesian analysis that uses aggregated published data, doses and responses of previous studies as well as the present allocated doses to advise further doses.
    Comparison groups
    Lidocaine 1% and lidocaine 2% each with adrenaline 1:200,000 f v Lidocaine 1% with adrenaline 1:200,000 and Prilocaine 1% for s
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 = 0 [8]
    Method
    		 CRM
    Parameter type
    		 adaptive
    Point estimate
    95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5
         upper limit
    		 99
    Variability estimate
    Standard deviation
    Dispersion value
    0
    Notes
    [7] - The ED95 dose estimate was determined using the modified CRM method (one parameter model).The posterior response probability of each dose level was re-estimated after inclusion of each cohort (2 patients). The dose allocated to each new cohort of patients was the dose level with the updated posterior response probability closest to 0.95. The dose-finding allocation was performed using R software version 3.2.2 (R cran). The study was stopped when the best estimate of ED95 was achieved.
    [8] - not applicable

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events occurring up to 24 hours following administration or before discharge from hospital (whichever is earlier) will be reported
    Adverse event reporting additional description
    Adverse events will be identified either by the Chief Investigator (CI) in the peri-operative period, the Principal Investigator (PI) during the following 24 hours or before the discharge by the nursing staff on the post-operative wards. The PI will report adverse event data as per the protocol.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    1.36.4
    Reporting groups
    Reporting group title
    Levo-bupivacaine 0.25% for interscalene brachial plexus block.
    Reporting group description
    		 The patients recruited in this arm of the study were listed for a shoulder surgery and had an interscalene brachial plexus block sited under a general anaesthetic as per the protocol. The interscalene arm of the study is a dose-finding trial for 0.25% levo-bupivacaine and is not randomised.Efficacy of the block was assessed by VAPS pain scores at 15, 30, 60 and 120 minute intervals after the patient comes to recovery (PACU), where 0 mm on a 100 mm scale is no pain and 100 mm is the worst imaginable pain.

    Reporting group title
    Lidocaine 1% with adrenaline 1:200,000 and Prilocaine 1% for s
    Reporting group description
    		 The patients recruited in this arm of the study were listed for an elbow, forearm or hand surgery. Consenting and eligible patients were randomised to either receive prilocaine 1% or lidocaine 1% with adrenaline (1:200,000) for an ultrasound guided supraclavicular block. Efficacy of the block was assessed at 10-minute intervals after siting the block, for up to 30 minutes at the sensory dermatomes of the median, ulnar, radial and musculocutaneous nerves in the upper limb to cold (i.e. at 10, 20, 30, minutes after the injection is finished).

    Reporting group title
    Lidocaine 1% and lidocaine 2% each with adrenaline 1:200,000 f
    Reporting group description
    		 The patients recruited in this arm of the study were listed for an elbow, forearm or hand surgery. Consenting and eligible patients were randomised to receive either lidocaine 1% with adrenaline (1:200,000) or lidocaine 2% with adrenaline (1:200,000) for an ultrasound guided axillary block under a local anaesthetic skin infilteration. Efficacy of the block was assessed at 10-minute intervals after siting the block, for up to 30 minutes at the sensory dermatomes of the median, ulnar, radial and musculocutaneous nerves in the upper limb to cold (i.e. at 10, 20, 30, minutes after the injection is finished).

    Serious adverse events
    		 Levo-bupivacaine 0.25% for interscalene brachial plexus block. Lidocaine 1% with adrenaline 1:200,000 and Prilocaine 1% for s Lidocaine 1% and lidocaine 2% each with adrenaline 1:200,000 f
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 73 (0.00%)
    0 / 81 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Levo-bupivacaine 0.25% for interscalene brachial plexus block. Lidocaine 1% with adrenaline 1:200,000 and Prilocaine 1% for s Lidocaine 1% and lidocaine 2% each with adrenaline 1:200,000 f
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 73 (1.37%)
    0 / 81 (0.00%)
    Gastrointestinal disorders
    Nausea, Vomiting
    Additional description: Postoperative
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 73 (1.37%)
    0 / 81 (0.00%)
         occurrences all number
    1
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Mar 2012
    Research ethics committee approval for increasing the number of trial subject to up to 300 patients
    14 Aug 2017
    Research ethics committee approval for modifying the way we provide patient information sheet to potential participants

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    14 Aug 2017
    Patient recruitment halted while the amendment was being considered by the research ethics committee.
    19 Sep 2017

    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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