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    Clinical Trial Results:
    PreMENAC: Multimodal Exercise/Nutrition/Anti-inflammatory treatment for Cachexia: A feasibility study (phase II)

    Summary
    EudraCT number
    2010-022897-14
    Trial protocol
    NO   GB   DK  
    Global end of trial date
    01 Sep 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    18 Sep 2016
    First version publication date
    18 Sep 2016
    Other versions
    Summary report(s)
    Results remenac summary

    Trial information

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    Trial identification
    Sponsor protocol code
    PreMENAC-2011-01
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01419145
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    NNorwegian University of Science and Technology (NTNU)
    Sponsor organisation address
    PB, Trondheim, Norway, 7491
    Public contact
    European Palliative Care Research Centre (PRC), European Palliative Care Research Centre (PRC), Department of Cancer Research and Molecular Me, prc@ntnu.no
    Scientific contact
    European Palliative Care Research Centre (PRC), European Palliative Care Research Centre (PRC), Department of Cancer Research and Molecular Me, prc@ntnu.no
    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
    01 Sep 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The overall objectives are the feasibility of patient recruitment, compliance to the multimodal intervention as well as the assessment of possible contamination of the control group. This will be assessed by: • Patient recruitment • Compliance to the intervention and attrition • Compliance with the data collection procedures • Contamination of the control group
    Protection of trial subjects
    There were no safety concerns identified. Eventual SAE and AEs were evaluated in the trial using CTCAE 3.0.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    03 Oct 2011
    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
    Norway: 23
    Country: Number of subjects enrolled
    United Kingdom: 23
    Worldwide total number of subjects
    46
    EEA total number of subjects
    46
    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)
    30
    From 65 to 84 years
    16
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Screened for eligibility (n=399)

    Pre-assignment period milestones
    Number of subjects started
    46
    Number of subjects completed
    46

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Experimental
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    M01A H01
    Investigational medicinal product code
    Other name
    Celebra
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg celexocib daily for 6 weeks

    Arm title
    Control
    Arm description
    -
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    Experimental Control
    Started
    25
    21
    Completed
    23
    18
    Not completed
    2
    3
         Consent withdrawn by subject
    1
    2
         Lost to follow-up
    1
    1

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Experimental
    Reporting group description
    -

    Reporting group title
    Control
    Reporting group description
    -

    Subject analysis set title
    Statistical analysis
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    The primary endpoint was feasibility. This was assessed by recruitment and retention (number of patients screened and/or consented), compliance with the intervention (based on use of celecoxib, nutritional supplements, and exercise performed), and contamination of the control arm (number of patients who tried to mimic all or part of the intervention). Feasibility of recruitment and retention was assessed by proportion of patients screened versus those consented and attrition rates.

    Primary: Feasibility

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    End point title
    Feasibility
    End point description
    The primary endpoint was feasibility. This was assessed by recruitment and retention (number of patients screened and/or consented), compliance with the intervention (based on use of celecoxib, nutritional supplements, and exercise performed), and contamination of the control arm (number of patients who tried to mimic all or part of the intervention). Feasibility of recruitment and retention was assessed by proportion of patients screened versus those consented and attrition rates. Compliance with the multimodal intervention was assessed according to individual components and thresholds of <50%, 50-80% and >80% were used. Compliance of >50% of the specific intervention in >50% of patients was considered acceptable.
    End point type
    Primary
    End point timeframe
    6 week
    End point values
    Experimental Control Statistical analysis
    Number of subjects analysed
    23
    18
    23 [1]
    Units: Number of patients
    23
    18
    23
    Notes
    [1] - Only assessed in the experimental arm
    Statistical analysis title
    Feasibility
    Comparison groups
    Experimental v Statistical analysis
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    ≤ 0.05
    Method
    t-test, 1-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    October 3rd 2011 and until September 1st 2014.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    Expermiental
    Reporting group description
    Reported grade 3 adverse event

    Serious adverse events
    Expermiental
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 25 (52.00%)
         number of deaths (all causes)
    25
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Thrombosis
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Infarction
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fever
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain
         subjects affected / exposed
    4 / 25 (16.00%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Dysphagia
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Obstruction
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Other
         subjects affected / exposed
    6 / 25 (24.00%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    Expermiental
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 25 (28.00%)
    Nervous system disorders
    Neutropenia
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Pain
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Gastrointestinal disorders
    rectal bleeding
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Infections and infestations
    Fever
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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