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    Clinical Trial Results:
    Prospective, double-blind, randomised trial to assess the efficacy of continuous sciatic/posterior tibial nerve blockade via a neural sheath catheter in lower limb amputees

    Summary
    EudraCT number
    2007-000619-27
    Trial protocol
    GB  
    Global end of trial date
    30 Apr 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    27 Dec 2019
    First version publication date
    27 Dec 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    56481676
    Additional study identifiers
    ISRCTN number
    ISRCTN68691928
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University Hospitals of Leicester NHS Trust
    Sponsor organisation address
    Research & Innovation, Trust HQ. Level 3 Balmoral Building. Leicester Royal Infirmary. , Leicester, United Kingdom, LE1 5WW
    Public contact
    Carolyn Maloney, University Hospitals of Leicester NHS Trust, +44 116 258 4109, carolyn.maloney@uhl-tr.nhs.uk
    Scientific contact
    Prof. Jonathan Thompson, University Hospitals of Leicester NHS Trust, jt23@le.ac.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
    30 Apr 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Apr 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To establish the effects of continuous peri- and post-operative sciatic/posterior tibial nerve blockade using a levobupivacaine infusion via a neural sheath catheter on late stump pain, phantom limb sensations and phantom limb pain.
    Protection of trial subjects
    All trial subjects (including intervention and control groups) received patient-controlled analgesia with morphine. All patients had access to further escape medication according to the protocol as required
    Background therapy
    Standardised surgery performed under standardised general anaesthesia
    Evidence for comparator
    Pain scores, requirements for analgesia, quality of life questionnaires
    Actual start date of recruitment
    01 Oct 2007
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Scientific research
    Long term follow-up duration
    12 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 90
    Worldwide total number of subjects
    90
    EEA total number of subjects
    90
    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)
    27
    From 65 to 84 years
    48
    85 years and over
    15

    Subject disposition

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    Recruitment
    Recruitment details
    Recruitment October 2007 to March 2013. Single UK centre

    Pre-assignment
    Screening details
    All patients admitted to the vascular unit at Leicester Royal Infirmary and planned for major lower limb amputation surgery (due to vascular aetiology) were considered for inclusion

    Period 1
    Period 1 title
    Recruitment (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Data analyst, Assessor
    Blinding implementation details
    Computer generated randomisation by an independent clinical trials unit

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Intervention group
    Arm description
    infusion of 0.125% Levobupivacaine at a rate of 8mls h-1 for 96hrs via a neural sheath catheter into the sciatic or posterior tibial nerve for above and below knee amputations respectively.
    Arm type
    Experimental

    Investigational medicinal product name
    levobupivacaine 0.125%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Perineural use
    Dosage and administration details
    infusion of 0.125% Levobupivacaine at a rate of 8mls h-1 for 96hrs via a neural sheath catheter into the sciatic or posterior tibial nerve for above and below knee amputations respectively.

    Arm title
    placebo control arm
    Arm description
    infusion of 0.9% saline at a rate of 8mls h-1 for 96hrs via a neural sheath catheter into the sciatic or posterior tibial nerve for above and below knee amputations respectively.
    Arm type
    Placebo

    Investigational medicinal product name
    0.9% saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Perineural use
    Dosage and administration details
    infusion of 0.9% saline at a rate of 8mls h-1 for 96hrs via a neural sheath catheter into the sciatic or posterior tibial nerve for above and below knee amputations respectively.

    Number of subjects in period 1
    Intervention group placebo control arm
    Started
    45
    45
    Completed
    41
    40
    Not completed
    4
    5
         Protocol deviation
    3
    4
         Adverse event, serious fatal
    -
    1
         Consent withdrawn by subject
    1
    -

    Baseline characteristics

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

    Reporting group values
    Recruitment Total
    Number of subjects
    90 90
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    27 27
        From 65-84 years
    48 48
        85 years and over
    15 15
        18 -100
    0 0
        Adults aged 18-64
    0 0
    Age continuous
    Female
    Units: years
        median (inter-quartile range (Q1-Q3))
    72 (62 to 82) -
    Gender categorical
    Male
    Units: Subjects
        Female
    32 32
        Male
    58 58

    End points

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    End points reporting groups
    Reporting group title
    Intervention group
    Reporting group description
    infusion of 0.125% Levobupivacaine at a rate of 8mls h-1 for 96hrs via a neural sheath catheter into the sciatic or posterior tibial nerve for above and below knee amputations respectively.

    Reporting group title
    placebo control arm
    Reporting group description
    infusion of 0.9% saline at a rate of 8mls h-1 for 96hrs via a neural sheath catheter into the sciatic or posterior tibial nerve for above and below knee amputations respectively.

    Primary: Presence or absence of significant phantom limb pain

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    End point title
    Presence or absence of significant phantom limb pain
    End point description
    End point type
    Primary
    End point timeframe
    6 months after intervention
    End point values
    Intervention group placebo control arm
    Number of subjects analysed
    30
    32
    Units: number
    7
    8
    Statistical analysis title
    chi squared test
    Comparison groups
    Intervention group v placebo control arm
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.05
    Method
    Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6 months
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    OED
    Dictionary version
    1
    Reporting groups
    Reporting group title
    experimental
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Serious adverse events
    experimental Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    22 / 41 (53.66%)
    24 / 43 (55.81%)
         number of deaths (all causes)
    7
    6
         number of deaths resulting from adverse events
    7
    6
    Vascular disorders
    Deep vein thrombosis postoperative
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb ischemia
         subjects affected / exposed
    3 / 41 (7.32%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Ischaemic small bowel
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    femoral and iliac vein thrombosis
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CVA
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Saddle embolus
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    messenteric vascular occlusion
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Revision of amputation
    Additional description: Below knee to above knee amputations
         subjects affected / exposed
    7 / 41 (17.07%)
    5 / 43 (11.63%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    loop colostomy
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SMA Embolectomy
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amputation
    Additional description: Vascular insufficiency left AKA
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    left CFA endarterectomy and a left profundaplasty
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angioplasty
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amputation of toes
    Additional description: Debridement and amputation of 1st,2nd and 3rd toes
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    iliac and profunda thrombectomy
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    axillo femoral bypass.
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Right hemicolectomy
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung cancer metastatic
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Brain Tumour
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Dementia
         subjects affected / exposed
    2 / 41 (4.88%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    disassociation disorder
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    delirium
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    0 / 41 (0.00%)
    4 / 43 (9.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychosis postoperative
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Recto vaginal fistula
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac arrest
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    SVT
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ECG changes
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IHD
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Exacerbation COPD
         subjects affected / exposed
    2 / 41 (4.88%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    pulmonary embolism
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonary nodules
    Additional description: possible lung metastasis
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest Infection
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    PR Bleeding
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
    Additional description: admitted with 24hr history of vomiting
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    small bowel ischaemia
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haematemesis due to severe eosophagitis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic encephalopathy
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Elevated Liver function tests
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Cellulitis
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erythema
    Additional description: right leg
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulcer
    Additional description: Non healing leg Ulcer
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peri orbital swelling
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stage 3 pressure sore
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Hairline pelvic fracture
    Additional description: Fall leading to fracture
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bakers Cyst
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hypoglycaemia
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Amputation wound infection
         subjects affected / exposed
    1 / 41 (2.44%)
    6 / 43 (13.95%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected Axillo femoral graft
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous ulceration infection
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected axillo femoral graft
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pressure sore infection
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    experimental Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 41 (14.63%)
    4 / 43 (9.30%)
    Gastrointestinal disorders
    nausea and vomiting
         subjects affected / exposed
    6 / 41 (14.63%)
    4 / 43 (9.30%)
         occurrences all number
    1
    1

    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
    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
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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