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    Clinical Trial Results:
    Oral Controlled Release Formulations to Patients with Gastrointestinal Dysfunction – Is the Release of Drug and the Absorption Impaired?

    Summary
    EudraCT number
    		 2017-000732-34
    Trial protocol
    		 DK  
    Global end of trial date
    22 May 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jan 2021
    First version publication date
    05 Jan 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ABOXY_2017
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Data Protection Agency : 2017-125, The North Denmark Region Committee on Health Rese: N-20170039
    Sponsors
    Sponsor organisation name
    Aalborg University Hospital
    Sponsor organisation address
    Mølleparkvej 4 , Aalborg, Denmark, 9000
    Public contact
    Louise Ladebo, Mech-Sense, Dept. Gastroenterology & Hepatology, Aalborg University Hospital, + 4597663520, l.ladebo@rn.dk
    Scientific contact
    Louise Ladebo , Mech-Sense, Dept. Gastroenterology & Hepatology, Aalborg University Hospital, + 4597663520, l.ladebo@rn.dk
    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
    18 Dec 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Apr 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    22 May 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of this study was to investigate the impact of GI-pathophysiology on net absorption of oxycodone administered as immediate release formulations and two different types of CRFs in patients with gastrointestinal disorders and to compare results obtained in healthy volunteers.
    Protection of trial subjects
    Not known.
    Background therapy
    		 -
    Evidence for comparator
    		 Participants were given one of three drugs: a) 10 mL Oxynorm 1mg/mL (oral solution, no dissolution parameter) b) 20 mg Oxycodonhydrochlorid “Lannacher” (swellable matrix based controlled release formulation) c) 20 mg Oxycodone Depot “Sandoz" (lipid based controlled release formulation) in a randomized order.
    Actual start date of recruitment
    15 May 2017
    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
    Denmark: 37
    Worldwide total number of subjects
    37
    EEA total number of subjects
    37
    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)
    37
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited by oral advertisement at lectures at Aalborg university, internal meetings at Aalborg University Hospital or Aalborg university, as well as, through www.forsøgsperson.dk, www.sundhed.dk, www.gb-foreningen.dk and relevant facebook groups.

    Pre-assignment
    Screening details
    		 Pre-screening by telefon of physical meeting with questions related to in- and exclusion criteria, followed by assessment by a medical doctor.

    Period 1
    Period 1 title
    Baseline characteristics
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Baseline characteristics
    Arm description
    		 Baseline characteristics obtained at this visit.
    Arm type
    		 Baseline characteristics

    Investigational medicinal product name
    No product - just baseline measurements
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    No dosage or drug was given at baseline. This visit was exclusively for obtainment of baseline measurements for all participants. The above was chosen, as the EudraCT system does not allow a baseline visit with a product being given.

    Number of subjects in period 1
    		Baseline characteristics
    Started
    37
    Completed
    37
    Period 2
    Period 2 title
    Treatment visits
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Assessor
    Blinding implementation details
    Semi-double blinded. Treatment medication was administered by personnel not involved in the study. Drugs were not blinded, by participants did not know which tablet was which. The individual treatment assignment for each participant was available in sealed envelopes (provided by the person who made the randomization list), stored in a secure area.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Oxynorm (oral solution)
    Arm description
    		 Administration of 10 mL oxynorm. Blood sampling, muscle pressure and pupil diameter was assessed over 24 hours.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Oxycodone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    10 mL of oral liquid oxycodone with 50 ml water.

    Arm title
    		 Lannacher, swellable matrix
    Arm description
    		 Administration of 20 mg oxycodone from water swellable controlled release formulation. Blood sampling, muscle pressure and pupil diameter was assessed over 24 hours.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Oxycodone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg of a prolonged-release oxycodone tablet (water-swellable matrix) was given with 240 ml water.

    Arm title
    		 Sandoz - lipid based CRF
    Arm description
    		 Administration of 20 mg oxycodone from lipid based matrix, controlled release formulation. Blood sampling, muscle pressure and pupil diameter was assessed over 24 hours.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Oxycodone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg of a prolonged-release oxycodone tablet (lipid matrix) was given with 240 ml water.

    Number of subjects in period 2
    		Oxynorm (oral solution) Lannacher, swellable matrix Sandoz - lipid based CRF
    Started
    37
    37
    37
    Completed
    35
    35
    35
    Not completed
    2
    2
    2
         Consent withdrawn by subject
    1
    1
    1
         Physician decision
    -
    1
    1
         Adverse event, non-fatal
    1
    -
    -
    Period 3
    Period 3 title
    Smartpill investigation
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Smartpill
    Arm description
    		 Smartpill investigation. Measurement of segmental pH, motility index and transit time of the stomach, small intestine and colon.
    Arm type
    		 Smartpill investigation

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3
    		Smartpill
    Started
    35
    Completed
    35

    Baseline characteristics

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

    Reporting group values
    		 Baseline characteristics Total
    Number of subjects
    		 37 37
    Age categorical
    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)
    		 37 37
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Age of all
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 42 (31 to 53) -
    Gender categorical
    Units: Subjects
        Female
    		 21 21
        Male
    		 16 16
    Subject analysis sets

    Subject analysis set title
    Healthy
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Healthy controls

    Subject analysis set title
    Roux-en-Y gastric bypass
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All Roux-en-Y gastric bypass

    Subject analysis sets values
    		 Healthy Roux-en-Y gastric bypass
    Number of subjects
    15
    22
    Age categorical
    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)
    15
    22
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Age of all
    Units: years
        median (inter-quartile range (Q1-Q3))
    31 (26 to 35.75)
    49 (35.5 to 58)
    Gender categorical
    Units: Subjects
        Female
    7
    14
        Male
    8
    8

    End points

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    End points reporting groups
    Reporting group title
    Baseline characteristics
    Reporting group description
    		 Baseline characteristics obtained at this visit.
    Reporting group title
    Oxynorm (oral solution)
    Reporting group description
    		 Administration of 10 mL oxynorm. Blood sampling, muscle pressure and pupil diameter was assessed over 24 hours.

    Reporting group title
    Lannacher, swellable matrix
    Reporting group description
    		 Administration of 20 mg oxycodone from water swellable controlled release formulation. Blood sampling, muscle pressure and pupil diameter was assessed over 24 hours.

    Reporting group title
    Sandoz - lipid based CRF
    Reporting group description
    		 Administration of 20 mg oxycodone from lipid based matrix, controlled release formulation. Blood sampling, muscle pressure and pupil diameter was assessed over 24 hours.
    Reporting group title
    Smartpill
    Reporting group description
    		 Smartpill investigation. Measurement of segmental pH, motility index and transit time of the stomach, small intestine and colon.

    Subject analysis set title
    Healthy
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Healthy controls

    Subject analysis set title
    Roux-en-Y gastric bypass
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All Roux-en-Y gastric bypass

    Primary: Primary endpoint

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    End point title
    		 Primary endpoint
    End point description
    The primary endpoint was if there were any differences in bioavailability between the two oral controlled release tablets in patients with a Roux-en-Y gastric bypass.
    End point type
    Primary
    End point timeframe
    First patient first visit to last patient last visit
    End point values
    		 Lannacher, swellable matrix Sandoz - lipid based CRF
    Number of subjects analysed
    20 [1]
    20 [2]
    Units: unitless
        number (not applicable)
    114
    114
    Notes
    [1] - Only Roux-en-y individuals
    [2] - Only Roux-en-Y individuals
    Statistical analysis title
    		 PKPD
    Statistical analysis description
    PKPD modelling was used to determine differences in bioavailability of the two controlled release formulations.
    Comparison groups
    Lannacher, swellable matrix v Sandoz - lipid based CRF
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 < 0.05
    Method
    		 Non-linear mixed effects
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 1000
    Notes
    [3] - PKPD modelling

    Secondary: Secondary endpoint

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    End point title
    		 Secondary endpoint
    End point description
    The secondary endpoint was if there was any different in bioavailability between healthy volunteers and patients with Roux-en-Y gastric bypass.
    End point type
    Secondary
    End point timeframe
    First patient first visit, last patient last visit
    End point values
    		 Healthy Roux-en-Y gastric bypass
    Number of subjects analysed
    15
    21 [4]
    Units: unitless
        number (not applicable)
    100
    114
    Notes
    [4] - All patients who received oxycodone
    Statistical analysis title
    		 PKPD modelling
    Statistical analysis description
    PKPD modelling
    Comparison groups
    Healthy v Roux-en-Y gastric bypass
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [5] - PKPD modelling

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first patient first visit to last patient last visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Oxynorm (arm 1)
    Reporting group description
    		 How many experienced side-effects.

    Reporting group title
    Lannacher (arm 2)
    Reporting group description
    		 Number experiencing side-effects

    Reporting group title
    Sandoz (arm 3)
    Reporting group description
    		 Number experiencing side-effects

    Serious adverse events
    		 Oxynorm (arm 1) Lannacher (arm 2) Sandoz (arm 3)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Allergic oedema
    Additional description: Quickes edema. Potential drug-drug interaction.
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Oxynorm (arm 1) Lannacher (arm 2) Sandoz (arm 3)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 36 (97.22%)
    33 / 35 (94.29%)
    34 / 35 (97.14%)
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    12 / 36 (33.33%)
    11 / 35 (31.43%)
    14 / 35 (40.00%)
         occurrences all number
    12
    11
    14
    Dizziness
         subjects affected / exposed
    19 / 36 (52.78%)
    22 / 35 (62.86%)
    20 / 35 (57.14%)
         occurrences all number
    19
    22
    20
    Sedation
         subjects affected / exposed
    32 / 36 (88.89%)
    31 / 35 (88.57%)
    30 / 35 (85.71%)
         occurrences all number
    32
    31
    30
    Immune system disorders
    Itching skin
         subjects affected / exposed
    7 / 36 (19.44%)
    8 / 35 (22.86%)
    12 / 35 (34.29%)
         occurrences all number
    7
    8
    12
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    11 / 36 (30.56%)
    13 / 35 (37.14%)
    11 / 35 (31.43%)
         occurrences all number
    11
    13
    11
    Vomiting
         subjects affected / exposed
    7 / 36 (19.44%)
    3 / 35 (8.57%)
    4 / 35 (11.43%)
         occurrences all number
    7
    3
    4
    Dry mouth
         subjects affected / exposed
    22 / 36 (61.11%)
    18 / 35 (51.43%)
    22 / 35 (62.86%)
         occurrences all number
    22
    18
    22
    Stomach ache
         subjects affected / exposed
    3 / 36 (8.33%)
    3 / 35 (8.57%)
    6 / 35 (17.14%)
         occurrences all number
    3
    3
    6
    Constipation
         subjects affected / exposed
    2 / 36 (5.56%)
    1 / 35 (2.86%)
    2 / 35 (5.71%)
         occurrences all number
    2
    1
    2
    Skin and subcutaneous tissue disorders
    Sweating
         subjects affected / exposed
    3 / 36 (8.33%)
    3 / 35 (8.57%)
    4 / 35 (11.43%)
         occurrences all number
    3
    3
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 May 2019
    The study was not completed in patients with diabetes nor short bowel as described in the protocol, as the study was very extensive

    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 number of gastric bypass participants was reduced from 30 to 20, as it was judged satisfactory.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31597014
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