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    Clinical Trial Results:
    A Multicenter Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postsurgical Analgesia in Pediatric Subjects Aged 6 to Less Than 17 Years

    Summary
    EudraCT number
    		 2020-005985-33
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    24 Sep 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jun 2021
    First version publication date
    28 Jun 2021
    Other versions
    Summary report(s)
    		 402-C-319 Clinical Study Report

    Trial information

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    Trial identification
    Sponsor protocol code
    402-C-319
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03682302
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pacira Pharmaceuticals, Inc.
    Sponsor organisation address
    5 Sylvan Way, Parsippany, United States, 07054
    Public contact
    Jennifer Gordon, Pacira Pharmaceuticals, Inc., 1 9734514055, jennifer.gordon@pacira.com
    Scientific contact
    Jennifer Gordon, Pacira Pharmaceuticals, Inc., 1 9734514055, jennifer.gordon@pacira.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000877-PIP03-17
    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
    13 May 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Sep 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate the pharmacokinetics (PK) of EXPAREL in pediatric subjects aged 6 to less than 17 years undergoing surgery.
    Protection of trial subjects
    Use of postsurgical pain medication in cases of insufficient analgesia was permitted according to each respective study site’s standard of care.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Apr 2019
    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 States: 95
    Worldwide total number of subjects
    95
    EEA total number of subjects
    0
    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)
    34
    Adolescents (12-17 years)
    61
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited between 02 April 2019 and 24 September 2019 at 15 sites in the US (both Groups).

    Pre-assignment
    Screening details
    		 Subjects were screened within 30 days prior to study drug administration. During the screening visit, subjects were assessed for past or present neurologic, cardiac, and general medical conditions that, in the opinion of the investigator, would preclude them from study participation.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 G1: 12- < than 17 years, undergoing spine surgery, EXPAREL
    Arm description
    		 Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
    Arm type
    		 Experimental

    Investigational medicinal product name
    EXPAREL
    Investigational medicinal product code
    Other name
    Liposomal bupivacaine, bupivacaine liposome injectable suspension
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Infiltration
    Dosage and administration details
    EXPAREL 4mg/kg (Maximum 266mg) single dose intraoperatively at the end of surgery via local infiltration

    Arm title
    		 G1: 12-<17 years, undergoing spine surgery, bupivacaine
    Arm description
    		 Single dose of bupivacaine hydrochloride (HCl) 2 mg/kg (not to exceed a maximum total dose of 175 mg) via local infiltration at the end of spine surgery.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    0.5% bupivacaine HCl
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Infiltration
    Dosage and administration details
    Single dose of bupivacaine hydrochloride (HCl) 2 mg/kg (not to exceed a maximum total dose of 175 mg) via local infiltration at the end of spine surgery.

    Arm title
    		 G2: 6-<12 years undergoing spine surgery, EXPAREL
    Arm description
    		 Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.
    Arm type
    		 Experimental

    Investigational medicinal product name
    EXPAREL
    Investigational medicinal product code
    Other name
    Liposomal bupivacaine, bupivacaine liposome injectable suspension
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Infiltration
    Dosage and administration details
    Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.

    Arm title
    		 G2: 6 - <12 years undergoing cardiac surgery, EXPAREL
    Arm description
    		 Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of cardiac surgery.
    Arm type
    		 Experimental

    Investigational medicinal product name
    EXPAREL
    Investigational medicinal product code
    Other name
    Liposomal bupivacaine, bupivacaine liposome injectable suspension
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Infiltration
    Dosage and administration details
    Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.

    Number of subjects in period 1
    		G1: 12- < than 17 years, undergoing spine surgery, EXPAREL G1: 12-<17 years, undergoing spine surgery, bupivacaine G2: 6-<12 years undergoing spine surgery, EXPAREL G2: 6 - <12 years undergoing cardiac surgery, EXPAREL
    Started
    31
    30
    5
    29
    Completed
    30
    28
    5
    28
    Not completed
    1
    2
    0
    1
         Lost to follow-up
    1
    2
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    G1: 12- < than 17 years, undergoing spine surgery, EXPAREL
    Reporting group description
    		 Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.

    Reporting group title
    G1: 12-<17 years, undergoing spine surgery, bupivacaine
    Reporting group description
    		 Single dose of bupivacaine hydrochloride (HCl) 2 mg/kg (not to exceed a maximum total dose of 175 mg) via local infiltration at the end of spine surgery.

    Reporting group title
    G2: 6-<12 years undergoing spine surgery, EXPAREL
    Reporting group description
    		 Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.

    Reporting group title
    G2: 6 - <12 years undergoing cardiac surgery, EXPAREL
    Reporting group description
    		 Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of cardiac surgery.

    Reporting group values
    		 G1: 12- < than 17 years, undergoing spine surgery, EXPAREL G1: 12-<17 years, undergoing spine surgery, bupivacaine G2: 6-<12 years undergoing spine surgery, EXPAREL G2: 6 - <12 years undergoing cardiac surgery, EXPAREL Total
    Number of subjects
    		 31 30 5 29 95
    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 in years
    Units: years
        arithmetic mean (standard deviation)
    		 13.8 ( 1.33 ) 13.9 ( 1.33 ) 10 ( 1.73 ) 8.7 ( 1.77 ) -
    Gender categorical
    Units: Subjects
        Female
    		 28 22 2 14 66
        Male
    		 3 8 3 15 29
    Ethnicity
    NIH/OMB
    Units: Subjects
        Hispanic or Latino
    		 10 7 0 9 26
        Not Hispanic or Latino
    		 19 23 5 20 67
        Unknown or Not Reported
    		 2 0 0 0 2
    Race
    NIH/OMB
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0
        Asian
    		 2 0 0 0 2
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 1 1
        Black or African American
    		 5 3 1 2 11
        White
    		 21 26 4 26 77
        More than one race
    		 1 1 0 0 2
        Unknown or Not Reported
    		 2 0 0 0 2
    American Society of Anesthesiologists classification
    American Society of Anesthesiologists (ASA) classification was determined by physicians using the ASA Physical Status Classification System which assesses the patient's pre-anesthesia medical co-morbidities. ASA 1 patients would be considered a normal, healthy patient. ASA 2 is a patient with mild systemic disease (eg, smoker, well controlled diabetes or high blood pressure (HBP)). ASA 3 is a patient with severe systemic disease (eg poorly controlled diabetes or HBP). ASA 4 is a patient with severe systemic disease that is a constant threat to life (eg, recent myocardial infarction, stroke).
    Units: Subjects
        ASA 1
    		 14 13 1 0 28
        ASA 2
    		 16 13 2 2 33
        ASA 3
    		 1 4 2 27 34

    End points

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    End points reporting groups
    Reporting group title
    G1: 12- < than 17 years, undergoing spine surgery, EXPAREL
    Reporting group description
    		 Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.

    Reporting group title
    G1: 12-<17 years, undergoing spine surgery, bupivacaine
    Reporting group description
    		 Single dose of bupivacaine hydrochloride (HCl) 2 mg/kg (not to exceed a maximum total dose of 175 mg) via local infiltration at the end of spine surgery.

    Reporting group title
    G2: 6-<12 years undergoing spine surgery, EXPAREL
    Reporting group description
    		 Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.

    Reporting group title
    G2: 6 - <12 years undergoing cardiac surgery, EXPAREL
    Reporting group description
    		 Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of cardiac surgery.

    Primary: Area Under the Plasma Concentration-versus-time Curve (AUC) 0 to Infinity

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    End point title
    		 Area Under the Plasma Concentration-versus-time Curve (AUC) 0 to Infinity [1]
    End point description
    The pharmacokinetic population consisted of subjects who received study drug and provided at least 1 quantifiable plasma concentration, with analysis by actual treatment received.
    End point type
    Primary
    End point timeframe
    15, 30, 45 min, 1-1.25h, 2-3h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 30-40, 45-55, 64-72h (cardiac surgery)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: PK analysis
    End point values
    		 G1: 12- < than 17 years, undergoing spine surgery, EXPAREL G1: 12-<17 years, undergoing spine surgery, bupivacaine G2: 6-<12 years undergoing spine surgery, EXPAREL G2: 6 - <12 years undergoing cardiac surgery, EXPAREL
    Number of subjects analysed
    15
    15
    2
    21
    Units: ng*h/mL
        arithmetic mean (standard deviation)
    14246.1 ( 9118.83 )
    5709.4 ( 3281.74 )
    11569.5 ( 7306.07 )
    26164.0 ( 28038.35 )
    No statistical analyses for this end point

    Primary: Maximum Plasma Concentration (Cmax)

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    End point title
    		 Maximum Plasma Concentration (Cmax) [2]
    End point description
    The pharmacokinetic population consisted of subjects who received study drug and provided at least 1 quantifiable plasma concentration, with analysis by actual treatment received.
    End point type
    Primary
    End point timeframe
    15, 30, 45 min, 1-1.25h, 2-3h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 30-40, 45-55, 64-72h(cardiac surgery)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: PK analysis
    End point values
    		 G1: 12- < than 17 years, undergoing spine surgery, EXPAREL G1: 12-<17 years, undergoing spine surgery, bupivacaine G2: 6-<12 years undergoing spine surgery, EXPAREL G2: 6 - <12 years undergoing cardiac surgery, EXPAREL
    Number of subjects analysed
    15
    15
    2
    21
    Units: ng/mL
        arithmetic mean (standard deviation)
    357.3 ( 125.31 )
    563.6 ( 320.93 )
    319.5 ( 164.76 )
    447.1 ( 243.41 )
    No statistical analyses for this end point

    Primary: The Apparent Terminal Elimination Half-life (t1/2el)

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    End point title
    		 The Apparent Terminal Elimination Half-life (t1/2el) [3]
    End point description
    The pharmacokinetic population consisted of subjects who received study drug and provided at least 1 quantifiable plasma concentration, with analysis by actual treatment received.
    End point type
    Primary
    End point timeframe
    15, 30, 45 min, 1-1.25h, 2-3h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 30-40, 45-55, 64-72h (cardiac surgery)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: PK analysis
    End point values
    		 G1: 12- < than 17 years, undergoing spine surgery, EXPAREL G1: 12-<17 years, undergoing spine surgery, bupivacaine G2: 6-<12 years undergoing spine surgery, EXPAREL G2: 6 - <12 years undergoing cardiac surgery, EXPAREL
    Number of subjects analysed
    15
    15
    2
    21
    Units: hours
        arithmetic mean (standard deviation)
    26.8 ( 21.26 )
    8.4 ( 6.26 )
    13.4 ( 4.60 )
    24.9 ( 20.58 )
    No statistical analyses for this end point

    Primary: Apparent Clearance (CL/F)

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    End point title
    		 Apparent Clearance (CL/F) [4]
    End point description
    The pharmacokinetic population consisted of subjects who received study drug and provided at least 1 quantifiable plasma concentration, with analysis by actual treatment received.
    End point type
    Primary
    End point timeframe
    15, 30, 45 min, 1-1.25h, 2-3h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 30-40, 45-55, 64-72h (cardiac surgery)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: PK analysis
    End point values
    		 G1: 12- < than 17 years, undergoing spine surgery, EXPAREL G1: 12-<17 years, undergoing spine surgery, bupivacaine G2: 6-<12 years undergoing spine surgery, EXPAREL G2: 6 - <12 years undergoing cardiac surgery, EXPAREL
    Number of subjects analysed
    15
    15
    2
    21
    Units: liters/hour
        arithmetic mean (standard deviation)
    17.5 ( 7.47 )
    20.5 ( 8.27 )
    14.5 ( 2.70 )
    7.4 ( 3.20 )
    No statistical analyses for this end point

    Primary: Apparent Volume of Distribution (Vd/F)

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    End point title
    		 Apparent Volume of Distribution (Vd/F) [5]
    End point description
    The pharmacokinetic population consisted of subjects who received study drug and provided at least 1 quantifiable plasma concentration, with analysis by actual treatment received.
    End point type
    Primary
    End point timeframe
    15, 30, 45 min, 1-1.25h, 2-3h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 30-40, 45-55, 64-72h (cardiac surgery)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: PK analysis
    End point values
    		 G1: 12- < than 17 years, undergoing spine surgery, EXPAREL G1: 12-<17 years, undergoing spine surgery, bupivacaine G2: 6-<12 years undergoing spine surgery, EXPAREL G2: 6 - <12 years undergoing cardiac surgery, EXPAREL
    Number of subjects analysed
    15
    15
    2
    21
    Units: Liters
        arithmetic mean (standard deviation)
    546.4 ( 269.42 )
    226.8 ( 110.63 )
    271.1 ( 43.58 )
    216.1 ( 83.77 )
    No statistical analyses for this end point

    Primary: Area Under the Plasma Concentration-versus-time Curve (AUC) 0 to Tlast

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    End point title
    		 Area Under the Plasma Concentration-versus-time Curve (AUC) 0 to Tlast [6]
    End point description
    The pharmacokinetic population consisted of subjects who received study drug and provided at least 1 quantifiable plasma concentration, with analysis by actual treatment received.
    End point type
    Primary
    End point timeframe
    15, 30, 45 min, 1-1.25h, 2-3h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 30-40, 45-55, 64-72h (cardiac surgery)
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: PK analysis
    End point values
    		 G1: 12- < than 17 years, undergoing spine surgery, EXPAREL G1: 12-<17 years, undergoing spine surgery, bupivacaine G2: 6-<12 years undergoing spine surgery, EXPAREL G2: 6 - <12 years undergoing cardiac surgery, EXPAREL
    Number of subjects analysed
    15
    15
    2
    21
    Units: ng*h/mL
        arithmetic mean (standard deviation)
    9042.5 ( 3762.82 )
    5232.9 ( 2538.37 )
    10249.6 ( 5956.56 )
    16776.4 ( 7935.80 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening through postsurgical Day 14
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    G1: 12-<17 years, undergoing spine surgery, bupivacaine
    Reporting group description
    		 Single dose of bupivacaine hydrochloride (HCl) 2 mg/kg (not to exceed a maximum total dose of 175 mg) via local infiltration at the end of spine surgery.

    Reporting group title
    G2: 6-<12 years undergoing spine surgery, EXPAREL
    Reporting group description
    		 Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.

    Reporting group title
    G2: 6 - <12 years undergoing cardiac surgery, EXPAREL
    Reporting group description
    		 Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of cardiac surgery.

    Reporting group title
    Group 1: 12-< 17 years, undergoing spine surgery, EXPAREL
    Reporting group description
    		 Single dose of EXPAREL 4 mg/kg (not to exceed a maximum total dose of 266 mg) via local infiltration at the end of spine surgery.

    Serious adverse events
    		 G1: 12-<17 years, undergoing spine surgery, bupivacaine G2: 6-<12 years undergoing spine surgery, EXPAREL G2: 6 - <12 years undergoing cardiac surgery, EXPAREL Group 1: 12-< 17 years, undergoing spine surgery, EXPAREL
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 5 (0.00%)
    2 / 29 (6.90%)
    0 / 31 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Gastrointestinal disorders
    vomiting, persistent
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 5 (0.00%)
    1 / 29 (3.45%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 5 (0.00%)
    1 / 29 (3.45%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Wound infection fungal
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 5 (0.00%)
    1 / 29 (3.45%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 G1: 12-<17 years, undergoing spine surgery, bupivacaine G2: 6-<12 years undergoing spine surgery, EXPAREL G2: 6 - <12 years undergoing cardiac surgery, EXPAREL Group 1: 12-< 17 years, undergoing spine surgery, EXPAREL
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 30 (73.33%)
    5 / 5 (100.00%)
    9 / 29 (31.03%)
    19 / 31 (61.29%)
    Injury, poisoning and procedural complications
    Anaemia postoperative
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 5 (20.00%)
    0 / 29 (0.00%)
    4 / 31 (12.90%)
         occurrences all number
    0
    1
    0
    4
    Delayed recovery from anesthesia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 5 (20.00%)
    0 / 29 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Seroma
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 5 (20.00%)
    0 / 29 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    7 / 30 (23.33%)
    2 / 5 (40.00%)
    0 / 29 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    7
    2
    0
    2
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    4 / 30 (13.33%)
    0 / 5 (0.00%)
    0 / 29 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    4
    0
    0
    1
    Bradycardia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 5 (20.00%)
    0 / 29 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    1
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 5 (0.00%)
    0 / 29 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    3
    0
    0
    2
    Headache
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 5 (0.00%)
    0 / 29 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Hypoaesthesia
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 5 (0.00%)
    0 / 29 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    4
    0
    0
    0
    Paranaesthesia
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 5 (0.00%)
    0 / 29 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Ear and labyrinth disorders
    Hypoacusis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 5 (0.00%)
    0 / 29 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    1
    0
    0
    2
    Eye disorders
    Vision Blurred
         subjects affected / exposed
    3 / 30 (10.00%)
    3 / 5 (60.00%)
    1 / 29 (3.45%)
    4 / 31 (12.90%)
         occurrences all number
    3
    3
    1
    4
    Visual Impairment
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 5 (0.00%)
    0 / 29 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    2
    0
    0
    2
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    9 / 30 (30.00%)
    1 / 5 (20.00%)
    4 / 29 (13.79%)
    8 / 31 (25.81%)
         occurrences all number
    9
    1
    4
    8
    Diarrhoea
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 5 (20.00%)
    0 / 29 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    1
    0
    2
    Nausea
         subjects affected / exposed
    6 / 30 (20.00%)
    1 / 5 (20.00%)
    2 / 29 (6.90%)
    10 / 31 (32.26%)
         occurrences all number
    6
    1
    2
    10
    Vomiting
         subjects affected / exposed
    5 / 30 (16.67%)
    1 / 5 (20.00%)
    4 / 29 (13.79%)
    9 / 31 (29.03%)
         occurrences all number
    5
    1
    4
    9
    Hypoaesthesia oral
         subjects affected / exposed
    3 / 30 (10.00%)
    3 / 5 (60.00%)
    0 / 29 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    3
    3
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 5 (40.00%)
    0 / 29 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    2
    2
    0
    1
    pruritis generalized
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 5 (0.00%)
    0 / 29 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    0
    1
    Renal and urinary disorders
    Incontinence
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 5 (0.00%)
    0 / 29 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    0
    0
    2
    Musculoskeletal and connective tissue disorders
    Muscle twitching
         subjects affected / exposed
    8 / 30 (26.67%)
    1 / 5 (20.00%)
    1 / 29 (3.45%)
    2 / 31 (6.45%)
         occurrences all number
    10
    1
    1
    2
    Muscle spasms
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 5 (20.00%)
    0 / 29 (0.00%)
    3 / 31 (9.68%)
         occurrences all number
    0
    1
    0
    3
    Muscular weakness
         subjects affected / exposed
    3 / 30 (10.00%)
    0 / 5 (0.00%)
    0 / 29 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    3
    0
    0
    0

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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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