Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Amino acids in ileal pouch-anal anastomosis for ulcerative colitis: a randomized, double-blind placebo-controlled trial

    Summary
    EudraCT number
    		 2014-000784-41
    Trial protocol
    		 DK  
    Global end of trial date
    01 Dec 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Sep 2019
    First version publication date
    21 Sep 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    2014010113
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department of medicine and endocrinology
    Sponsor organisation address
    Palle Juul-Jensens Boulevard 99, Aarhus, Denmark, 8200
    Public contact
    Colorectal research unit, Anders Mark Christensen, Department of surgery P, Aarhus University Hospital, +45 78467712, amch@clin.au.dk
    Scientific contact
    Colorectal research unit, Anders Mark Christensen, Department of surgery P, Aarhus University Hospital, +45 78467712, amch@clin.au.dk
    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
    13 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Dec 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Dec 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To investigate the metabolic effects of intravenous amino acids given during ileal pouch-anal anastomosis surgery for ulcerative colitis.
    Protection of trial subjects
    Trial subjects were either under general anesthesia (as part of the planned operation) or received infiltration anasthesia during biopsy collection, while they were still under some influence of general anesthesia.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jan 2016
    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
    Denmark: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    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)
    8
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Seventy-two subjects screened with only eight included. Reasons for exclusion were primarily age (>50) and an unwillingness to participate in the trial.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Vaminolac
    Arm description
    		 Amino acids
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vaminolac
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Weight-adjusted: Weight (in kilograms) x 1,6 = infusion rate (ml/hour)

    Arm title
    		 Placebo
    Arm description
    		 Saline
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Weight-adjusted: Weight (in kilograms) x 1,6 = infusion rate (ml/hour).

    Investigational medicinal product name
    Vaminolac
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Weight-adjusted: Weight (in kilograms) x 1,6 = infusion rate (ml/hour)

    Number of subjects in period 1
    		Vaminolac Placebo
    Started
    5
    3
    Completed
    5
    3

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Vaminolac
    Reporting group description
    		 Amino acids

    Reporting group title
    Placebo
    Reporting group description
    		 Saline

    Reporting group values
    		 Vaminolac Placebo Total
    Number of subjects
    		 5 3 8
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 5 3 8
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 0 1 1
        Male
    		 5 2 7
    Subject analysis sets

    Subject analysis set title
    Change in insulin
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo/saline.

    Subject analysis set title
    Change in insulin
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Amino acids.

    Subject analysis sets values
    		 Change in insulin Change in insulin
    Number of subjects
    3
    5
    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)
    3
    5
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Vaminolac
    Reporting group description
    		 Amino acids

    Reporting group title
    Placebo
    Reporting group description
    		 Saline

    Subject analysis set title
    Change in insulin
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo/saline.

    Subject analysis set title
    Change in insulin
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Amino acids.

    Primary: Changes in amino acid and fat rate of appearance

    		 Close Top of page
    End point title
    		 Changes in amino acid and fat rate of appearance [1]
    End point description
    End point type
    Primary
    End point timeframe
    Not applicable. Analyses not performed owing to too few trial subjects (futility in recruiting).
    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: Primary end-point not analyzed owing to premature end of trial (futility in recruiting patients).
    End point values
    		 Change in insulin Change in insulin
    Number of subjects analysed
    5 [2]
    3 [3]
    Units: NA
        number (not applicable)
    00
    00
    Notes
    [2] - Not performed.
    [3] - Not performed.
    No statistical analyses for this end point

    Secondary: Change in insulin

    		 Close Top of page
    End point title
    		 Change in insulin
    End point description
    End point type
    Secondary
    End point timeframe
    Change from value at one 60 minutes before intervention to 300 minutes after.
    End point values
    		 Change in insulin Change in insulin
    Number of subjects analysed
    3 [4]
    5 [5]
    Units: pmol/L
        median (full range (min-max))
    2 (-27 to 7)
    20 (-4 to 79)
    Notes
    [4] - Placebo/saline
    [5] - Amino acids.
    Statistical analysis title
    		 Wilcoxon rank sum
    Comparison groups
    Change in insulin v Change in insulin
    Number of subjects included in analysis
    8
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.1
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (net)
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events were ascertained from the time tracer infusions were initiated until reversal of loop ileostomy or first out-patient visit.
    Adverse event reporting additional description
    As per CT3.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CT3
    Dictionary version
    NA
    Reporting groups
    Reporting group title
    Amino acids
    Reporting group description
    		 -

    Reporting group title
    Placebo (saline)
    Reporting group description
    		 -

    Serious adverse events
    		 Amino acids Placebo (saline)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Amino acids Placebo (saline)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: It is impossible to register this on here. Six non-serious adverse events in the amino acid group and two in the placebo group.

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Dec 2017
    Premature termination of the trial due to futility in recruiting patients.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Thu May 29 23:07:07 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA