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    Clinical Trial Results:
    A double blind randomised parallel group trial of paracetamol versus placebo in conjunction with strong opioids for cancer related pain.

    Summary
    EudraCT number
    2016-000197-38
    Trial protocol
    GB  
    Global end of trial date
    31 Aug 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    02 Jul 2021
    First version publication date
    02 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AC15006
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02706769
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    ACCORD (University of Edinburgh and NHS Lothian)
    Sponsor organisation address
    47 Little France Crescent, Edinburgh, United Kingdom, EH16 4TJ
    Public contact
    Professor Marie Fallon, University of Edinburgh, 0044 01316518600, marie.fallon@ed.ac.uk
    Scientific contact
    Professor Marie Fallon, University of Edinburgh, 0044 01316518600, marie.fallon@ed.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
    26 Jun 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To establish whether paracetamol in combination with strong opioids provides superior analgesia for cancer related pain over strong opioids alone.
    Protection of trial subjects
    N/A
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    19 Jun 2016
    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 Kingdom: 28
    Worldwide total number of subjects
    28
    EEA total number of subjects
    28
    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)
    7
    From 65 to 84 years
    20
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    N/A

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Paracetamol
    Arm description
    Paracetamol 1 gram four times daily.
    Arm type
    Active comparator

    Investigational medicinal product name
    Paracetamol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Participants took paracetamol 1 gram (two capsules) four times daily (each dose at least 4 hours apart) for the 7 days of the intervention phase of the study. All capsules were consumed whole. Participants were issued with the medication on day 0 (day of randomisation) and asked to commence it the following day instead of their current usual paracetamol medication.

    Arm title
    Placebo
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Other use
    Dosage and administration details
    Participants took placebo (two capsules) four times daily (each dose at least 4 hours apart) for the 7 days of the intervention phase of the study. All capsules were consumed whole. Participants were issued with the placebo on day 0 (day of randomisation) and asked to commence it the following day instead of their current usual paracetamol medication.

    Number of subjects in period 1
    Paracetamol Placebo
    Started
    13
    15
    Completed
    13
    15

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Paracetamol
    Reporting group description
    Paracetamol 1 gram four times daily.

    Reporting group title
    Placebo
    Reporting group description
    -

    Primary: Clinically relevant change in average pain score

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    End point title
    Clinically relevant change in average pain score [1]
    End point description
    End point type
    Primary
    End point timeframe
    Between baseline (day 0) and end of study (day 8).
    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: A full statistical analysis plan is available. The proportion of participants showing a clinically relevant change in average pain score over treatment period was compared using a binomial test for the comparison of proportions, the difference in proportions was presented along with an accompanying 95% CI.
    End point values
    Paracetamol Placebo
    Number of subjects analysed
    11
    12
    Units: Points between 0 and 10
    3
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All AEs and SAEs were recorded from the time a participant signed their consent form to take part in the study until completion of the study (day 8) or withdrawal from the study.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21
    Frequency threshold for reporting non-serious adverse events: 0%
    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: Study closed early - only 23 patients completed.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Oct 2017
    Change to protocol to help increase recruitment: 1. Reduce the minimum average pain score from 4 to 2. 2. Reduce the time on the study drug from 2 weeks to 1 week. 3. Use a poster/leaflet to alert potentially eligible patients to the study (eg in relevant clinic waiting rooms). 4. Remove the inclusion criteria that participants should be under palliative care/oncology service review. This will enable recruitment via primary care, with support from the primary care network, who can send letters to potentially eligible patients at GP practices who volunteer to take part. 5. Omit the screening period for the group already on paracetamol, where they are able to reliably report stable pain for the last 3 days (in the opinion of the researcher). 6. Include a new post-trial assessment, to capture any changes in pain due to resumption of usual paracetamol or otherwise after the study. 7. Allow issuing of Participant Information Sheet and taking consent to occur on the same day. 8. Allow baseline assessments to be conducted by phone as well as in person.

    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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