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    Clinical Trial Results:
    Pain management in osteoarthritis using the centrally acting analgesics duloxetine and pregabalin

    Summary
    EudraCT number
    2011-003803-39
    Trial protocol
    GB  
    Global end of trial date
    27 Oct 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    20 Nov 2019
    First version publication date
    20 Nov 2019
    Other versions
    Summary report(s)
    Journal of Pain Research Article

    Trial information

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    Trial identification
    Sponsor protocol code
    11.0126
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    St Georges University of London
    Sponsor organisation address
    Cranmer Terrace, London, United Kingdom, SW17 0RE
    Public contact
    Joint Research and Enterprise Service, St George's University of London, 44 02087254986, sponsor@sgul.ac.uk
    Scientific contact
    Prof Nidhi Sofat, St George's University of London, 44 02087250042, nsofat@sgul.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
    10 Nov 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Oct 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Oct 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The proposed study is based on the hypothesis that pain in hand osteoarthritis is due to local changes in the joint and the switching on of pain pathways in the brain that mediate chronic pain. The overall aim of this study is to determine whether drugs which influence central brain pain processing pathways can improve pain management in hand osteoarthritis. The primary objective of this study is to determine the effects of centrally acting drugs duloxetine and pregabalin versus placebo on pain perception in hand osteoarthritis using clinical pain scores.
    Protection of trial subjects
    Interim analysis will not be completed due to the small size of the study. Although duloxetine and pregabalin are already known to be safe, there is also the possibility of drug intolerance and/or side effects. Participants will be provided with a helpline phone number to discuss any concerns or queries regarding the study. They will also be given diary cards to record their experiences during the trial.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Aug 2012
    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
    United Kingdom: 65
    Worldwide total number of subjects
    65
    EEA total number of subjects
    65
    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)
    35
    From 65 to 84 years
    30
    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
    65
    Number of subjects completed
    65

    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

    Arms
    Arm title
    Trial treatment
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Pregabalin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150mg od week 1, increased to 150mg bd weeks 2-11, reduced to 150mg od week 12 

    Investigational medicinal product name
    Duloxetine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    30mg od week 1, increased to 30 mg bd weeks 2-11, reduced to 30mg od week 12 

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 capsule per day week 1, increased to 1 capsule bd weeks 2-11 reduced to 1 capsule daily week 12

    Number of subjects in period 1
    Trial treatment
    Started
    65
    Completed
    52
    Not completed
    13
         Consent withdrawn by subject
    13

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Trial treatment
    Reporting group description
    -

    Primary: Change in Visual Analogue Score (VAS) for pain

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    End point title
    Change in Visual Analogue Score (VAS) for pain [1]
    End point description
    End point type
    Primary
    End point timeframe
    Completion of the study, the change in VAS from baseline to 13 weeks will be used as the primary clinical endpoint for each participant.
    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: These are provided in the trial publication.
    End point values
    Trial treatment
    Number of subjects analysed
    52
    Units: 00
        number (not applicable)
    52
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Collection, recording and reporting of AEs (including serious and non-serious events and reactions) to the Sponsor will be done according to the Sponsor within 24hrs of PI becoming aware
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    0
    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: Adverse Event data can be found in the publication article.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Jun 2012
    Substantial amendment 01; 08 June 2012 Sponsor representative changed Both handedness included. Clarification of inclusion #5. Removal of dominant left hand and clarification of exclusion #10 as eGFR <60ml/min. Clarification of recent surgery and implants timeframe. Clarification of concomitant medication. Addition of hepatic impairment exclusion criteria in exclusion criteria #11. Clarification of maximum units of alcohol for females and males in exclusion criteria #14 Clarification of dose escalation from week 2 to week 11 and dose reduction on week 12. Also clarified in section 11.4 of protocol in the similar manner. Clarification of text to state that all SAEs will be reported.
    06 Dec 2012
    Substantial Amendment 02; dated 06th December 2012 Clarification of exclusion critieria 12 and 13 to state uncontrolled ischaemic heart disease and diabetes mellitus Addition of sub study into secondary objective to include MRI scanning pre and post treatment at baseline and Week 13 for up to 18 participants Addition of baseline assessments to include MRI scanning Addition of subsequent assessments to include MRI scanning Clarification to state hand x rays are part of routine clinical care Addition to declaration of end of trial Addition of MRI to secondary endpoints. Schedule of study assessments updated with MRI scans Addition of MRI scan to PIS
    07 Jun 2013
    Substantial amendment 3 dated 7 June 2013 Additional documents to increase study publicity. - GP practice mail out letters to potential participants - Patient mail-out letters - Posters
    06 Aug 2013
    Substantial Amendment 4- Amendment date: 06 August 2013 In order for patients to maximize the benefits of partaking in the study, as well as being able to measure a significant change in the patient's pain perception; we aim to recruit participants with a VAS score equal to 5/10 or above
    07 Nov 2014
    Amendment number: 5 Amendment date: 07 November 2014 Following patient drop outs and expiration of 1st IMP batch- 2nd batch manufactured to allow replacement and where IMP stock allow increased patient recruitment (increase study power) Also it has been suggested that MRI control scans of healthy volunteers without OA should be collected for comparison Correction in definition in line with new recruitment intentions Updated to reflect intention to extend recruitment to facilitate replacement of drop-outs and also to add rationale for inclusion of healthy non-OA MRI brain controls To reflect updated study participants Brand new document for MRI healthy volunteer non-OA brain controls

    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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