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    Clinical Trial Results:
    Treatment satisfaction and self-reported symptoms in patients under opioid maintenance therapy

    Summary
    EudraCT number
    		 2015-002440-13
    Trial protocol
    		 AT  
    Global end of trial date
    24 Oct 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Nov 2020
    First version publication date
    20 Nov 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OMT-Satisfaction
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Innsbruck
    Sponsor organisation address
    Christoph-Probst-Platz 1, Innrain 52 A, Innsbruck, Austria, 6020
    Public contact
    Ao. Univ.Prof. Dr. Sergei Mechtcheriakov, Medical University Innsbruck, Department of Psychiatry, Anichstrasse 35, 6020 Innsbruck, +43 50504 49010, sergei.mechtcheriakov@tirol-kliniken.at
    Scientific contact
    Ao. Univ.Prof. Dr. Sergei Mechtcheriakov, Medical University Innsbruck, Department of Psychiatry, Anichstrasse 35, 6020 Innsbruck, +43 50504 49010, sergei.mechtcheriakov@tirol-kliniken.at
    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
    24 Oct 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Oct 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This clinical trial aims to systematically collect the treatment related data during the standard clinical OMT course including eventual medication switches. The patients on OMT which manifest with medical, psychological and social-environmental reasons for treatment optimization (incl. the switch of OMT-medication) will be systematically monitored during the treatment regarding their addiction-related behavioral parameters, side-effects, compliance parameters and treatment satisfaction. This study aims to investigate to what extent patient’s satisfaction with the current OMT treatment influences compliance and outcome.
    Protection of trial subjects
    N/A
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 8 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 99999
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    99999
    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)
    99999
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 No patients were recruited for this trial . "99999" is a value for 0 participants.

    Pre-assignment
    Screening details
    		 N/A

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 SROM
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Substitol retard 200 mg
    Investigational medicinal product code
    Other name
    Morphine Sulfate
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Methadone can be switched to SROM from one day to the other in a ratio of 1:6-8 of the previous methadone dose. SROM can be commenced 24 hours after the last dose of buprenorphine, at an initial maximum daily dose of 320 mg morphine (maximum 400 mg). The selection of the first SROM dose should be based on a 1:30-50 ratio.

    Investigational medicinal product name
    Substitol retard 120 mg
    Investigational medicinal product code
    Other name
    Morphine Sulfate
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Methadone can be switched to SROM from one day to the other in a ratio of 1:6-8 of the previous methadone dose. SROM can be commenced 24 hours after the last dose of buprenorphine, at an initial maximum daily dose of 320 mg morphine (maximum 400 mg). The selection of the first SROM dose should be based on a 1:30-50 ratio.

    Investigational medicinal product name
    Compensan retard 300 mg
    Investigational medicinal product code
    Other name
    Morphinhydrochlorid-Trihydrat
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Methadone can be switched to SROM from one day to the other in a ratio of 1:6-8 of the previous methadone dose. SROM can be commenced 24 hours after the last dose of buprenorphine, at an initial maximum daily dose of 320 mg morphine (maximum 400 mg). The selection of the first SROM dose should be based on a 1:30-50 ratio.

    Investigational medicinal product name
    Compensan retard 200 mg
    Investigational medicinal product code
    Other name
    Morphinhydrochlorid-Trihydrat
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Methadone can be switched to SROM from one day to the other in a ratio of 1:6-8 of the previous methadone dose. SROM can be commenced 24 hours after the last dose of buprenorphine, at an initial maximum daily dose of 320 mg morphine (maximum 400 mg). The selection of the first SROM dose should be based on a 1:30-50 ratio.

    Investigational medicinal product name
    Compensan retard 100 mg
    Investigational medicinal product code
    Other name
    Morphinhydrochlorid-Trihydrat
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Methadone can be switched to SROM from one day to the other in a ratio of 1:6-8 of the previous methadone dose. SROM can be commenced 24 hours after the last dose of buprenorphine, at an initial maximum daily dose of 320 mg morphine (maximum 400 mg). The selection of the first SROM dose should be based on a 1:30-50 ratio.

    Investigational medicinal product name
    Methadon
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Methadon is part of the Opioid maintenance treatment (OMT).

    Investigational medicinal product name
    Bupensan 8 mg
    Investigational medicinal product code
    Other name
    Buprenorphinhydrochlorid
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Bupensan is part of the Opioid maintenance treatment (OMT).

    Investigational medicinal product name
    Bupensan 4 mg
    Investigational medicinal product code
    Other name
    Buprenorphinhydrochlorid
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Bupensan is part of the Opioid maintenance treatment (OMT).

    Investigational medicinal product name
    Bupensan 2 mg
    Investigational medicinal product code
    Other name
    Buprenorphinhydrochlorid
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Bupensan is part of the Opioid maintenance treatment (OMT).

    Investigational medicinal product name
    L-Polamidon Solution
    Investigational medicinal product code
    Other name
    Levomethadone hydrochloride
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    L-Polamidon Solution is part of the Opioid maintenance treatment (OMT).

    Investigational medicinal product name
    Subutex 8 mg
    Investigational medicinal product code
    Other name
    Buprenorphine
    Pharmaceutical forms
    Tablet
    Routes of administration
    Sublingual use
    Dosage and administration details
    Subutex is part of the Opioid maintenance treatment (OMT).

    Investigational medicinal product name
    Subutex 2 mg
    Investigational medicinal product code
    Other name
    Buprenorphine
    Pharmaceutical forms
    Tablet
    Routes of administration
    Sublingual use
    Dosage and administration details
    Subutex is part of the Opioid maintenance treatment (OMT).

    Investigational medicinal product name
    Subutex 0.4 mg
    Investigational medicinal product code
    Other name
    Buprenorphine
    Pharmaceutical forms
    Tablet
    Routes of administration
    Sublingual use
    Dosage and administration details
    Subutex is part of the Opioid maintenance treatment (OMT).

    Investigational medicinal product name
    Suboxone 8 mg/2mg
    Investigational medicinal product code
    Other name
    Buprenorphine Hydrochloride
    Pharmaceutical forms
    Tablet
    Routes of administration
    Sublingual use
    Dosage and administration details
    Suboxone is part of the Opioid maintenance treatment (OMT).

    Investigational medicinal product name
    Suboxone 2 mg/0.5mg
    Investigational medicinal product code
    Other name
    Buprenorphine Hydrochloride
    Pharmaceutical forms
    Tablet
    Routes of administration
    Sublingual use
    Dosage and administration details
    Suboxone is part of the Opioid maintenance treatment (OMT).

    Number of subjects in period 1
    		SROM
    Started
    99999
    Completed
    99999

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    		 -

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 99999 99999
    Age categorical
    "99999" is a value for 0 participants.
    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)
    		 99999 99999
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    "99999" is a value for 0 participants.
    Units: years
        arithmetic mean (standard deviation)
    		 0 ± 0 -
    Gender categorical
    "99999" is a value for 0 particpants.
    Units: Subjects
        Female
    		 99999 99999
        Male
    		 0 0

    End points

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

    Primary: Treatment satisfaction

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    End point title
    		 Treatment satisfaction [1]
    End point description
    End point type
    Primary
    End point timeframe
    N/A
    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: No subjects were included in this trial, therefore no statistical analyses was done.
    End point values
    		 SROM
    Number of subjects analysed
    99999 [2]
    Units: ODAS
        number (not applicable)
    99999
    Notes
    [2] - "99999" is a value for 0 participats.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    01.12.2015- 24.10.2016
    Adverse event reporting additional description
    No patients were included in this trial , therefore no AEs and SAEs were observed.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    SROM
    Reporting group description
    		 -

    Serious adverse events
    		 SROM
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 99999 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 SROM
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 99999 (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: No subjects were included in this trial, therefore no AEs or SAEs were observed.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Feb 2016
    Slight amendments concerning CRF, insurance and protocol
    21 Mar 2016
    Another PI

    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.
    No subjects were enrolled in this trial. "99999" is a value for 0 participants , as it was not possible to fill in "0" for the number of included patients.
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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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