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    Clinical Trial Results:
    Pharmacological treatment of insomnia in palliative care A randomized, double-blind, placebo controlled, parallel-group, multicenter trial investigating the short time effectiveness of zopiclone on self-reported sleep quality in patients with advanced cancer who use opioids and who report insomnia

    Summary
    EudraCT number
    		 2015-005306-11
    Trial protocol
    		 NO  
    Global end of trial date
    01 May 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Oct 2022
    First version publication date
    15 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SleepRCT_270215
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02807922
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    St. Olavs Hospital, Trondheim University Hospital
    Sponsor organisation address
    Postboks 3250 Torgarden, Trondheim, Norway, 7006
    Public contact
    Pål Klepstad, St. Olavs Hospital, Trondheim University Hospital, +47 72575709, pal.klepstad@ntnu.no
    Scientific contact
    Pål Klepstad, St. Olavs Hospital, Trondheim University Hospital, +47 72575709, pal.klepstad@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 May 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 May 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    01 May 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to study the short time effectiveness of zopiclone on patient reported sleep quality in patients with advanced cancer who use opioids and who report insomnia.
    Protection of trial subjects
    The trial was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with Good Clinical Practice. The protocol was considered as a low-risk study. The patients were instructed to contact the investigator immediately should they manifest any signs or symptoms.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 May 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
    Norway: 41
    Worldwide total number of subjects
    41
    EEA total number of subjects
    41
    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)
    0
    From 65 to 84 years
    41
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 41
    Number of subjects completed
    		 41

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Zopiclone
    Arm description
    		 Zopiclone "Actavis"
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Actavis
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    3.75 mg, 5 mg, 7.5

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    3.75 mg, 5 mg, and 7.5 mg

    Number of subjects in period 1
    		Zopiclone Placebo
    Started
    20
    21
    Completed
    18
    21
    Not completed
    2
    0
         Consent withdrawn by subject
    1
    -
         Due to radiotherapy at another hospital
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Zopiclone
    Reporting group description
    		 Zopiclone "Actavis"

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group values
    		 Zopiclone Placebo Total
    Number of subjects
    		 20 21 41
    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)
    		 0 0 0
        From 65-84 years
    		 20 21 41
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (standard deviation)
    		 61 ± 55.6 68 ± 57.1 -
    Gender categorical
    Units: Subjects
        Female
    		 8 9 17
        Male
    		 12 12 24
    Subject analysis sets

    Subject analysis set title
    Primary endpoint
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients analysed

    Subject analysis sets values
    		 Primary endpoint
    Number of subjects
    39
    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
    39
        85 years and over
    0
    Age continuous
    Units: years
        median (standard deviation)
    ±
    Gender categorical
    Units: Subjects
        Female
    17
        Male
    22

    End points

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    End points reporting groups
    Reporting group title
    Zopiclone
    Reporting group description
    		 Zopiclone "Actavis"

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Subject analysis set title
    Primary endpoint
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients analysed

    Primary: Sleep quality

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    End point title
    		 Sleep quality
    End point description
    End point type
    Primary
    End point timeframe
    Sleep quality at night 6 with treatment
    End point values
    		 Zopiclone Placebo Primary endpoint
    Number of subjects analysed
    18
    21
    39
    Units: 0-10
        arithmetic mean (confidence interval 95%)
    2.9 (2.3 to 3.8)
    4.5 (3.6 to 5.4)
    2.9 (2.3 to 3.8)
    Statistical analysis title
    		 Independent student’s t-test
    Statistical analysis description
    In the comparison of sleep quality between the two groups after night 6 of using the study drug, independent student’s t-test was used for continues variables
    Comparison groups
    Placebo v Zopiclone
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 ≤ 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The treatment is 6 subsequent nights with zopiclone or placebo
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Zopiclone
    Reporting group description
    		 Zopiclone "Actavis"

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 Zopiclone Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 21 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Zopiclone Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    Nervous system disorders
    Dizziness
    Additional description: temporary dizziness
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0

    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.
    The main limitation is the number of patients enrolled. Because of slow recruitment the trial was stopped before the pre-defined target of patients was reached. However, the risk for a potential type two error was mitigated by the statistically signi
    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.

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