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    Clinical Trial Results:
    An Open-label, Multicentre Study of the Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Opioid Experienced Children from Ages 6 to 16 Years Old, Inclusive, with Moderate to Severe Malignant and/or Nonmalignant Pain Requiring Opioid Analgesics.

    Summary
    EudraCT number
    		 2010-020471-23
    Trial protocol
    		 GB   HU   SK   DE   FI   ES   EE   BE   GR   PL   SE   BG  
    Global end of trial date
    29 Jul 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Jul 2016
    First version publication date
    07 Aug 2015
    Other versions
    Summary report(s)
    		 OTR3001_Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    OTR3001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01192295
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Purdue Pharma L.P
    Sponsor organisation address
    One Stamford Forum, Stamford, United States, CT 06901-3431
    Public contact
    Purdue Pediatric Call Centre, PRA International, +1 434 951 4115, PurduePediatric@praintl.com
    Scientific contact
    Purdue Pediatric Call Centre, PRA International, +1 434 951 4115, PurduePediatric@praintl.com
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Nov 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to characterize the safety of oxycodone HCl CR tablets in opioid tolerant pediatric patients aged 6 to 16 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy.
    Protection of trial subjects
    An independent Data Monitoring Committee (DMC) was established to review the accumulating safety data from the trial. The DMC met periodically 6 times, during the course of the study to review safety data and make recommendations to Purdue Pharma L.P. regarding early stopping of the study, continuation of the study, or modification of the study protocol as needed.
    Background therapy
    		 NA
    Evidence for comparator
    		 NA
    Actual start date of recruitment
    28 Feb 2011
    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
    Spain: 1
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    Greece: 3
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    Guatemala: 1
    Country: Number of subjects enrolled
    Israel: 10
    Country: Number of subjects enrolled
    United States: 134
    Country: Number of subjects enrolled
    New Zealand: 2
    Worldwide total number of subjects
    155
    EEA total number of subjects
    8
    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)
    27
    Adolescents (12-17 years)
    128
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First Patint First Visit: 28 February 2011; Last Patient Last Visist: 29 July 2014. The study was conducted at medical/research sites in the United Staes, Spain, United Kingdom, Greece, Guatemala, Hungary, Israel, and New Zealand

    Pre-assignment
    Screening details
    		 Patients taking around-the-clock opioid medication for at least 5 consecutive days prior to taking the study drug and with at least 20 mg daily and no more than 240 mg daily of oxycodone or the equivalent for at least 48 hours before beginning the study

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was an open lable study potential subjects were assigned a subject number at the time of screening

    Arms
    Arm title
    		 Open label treatment
    Arm description
    		 Twice Daily Oxycodone Hydrochloride Controlled-release Tablets
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oxycodone Hydrochloride Twice Daily Controlled-release Tablets
    Investigational medicinal product code
    Oxycodone HCl CR
    Other name
    NA
    Pharmaceutical forms
    Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oxycodone HCl controlled-release (CR) twice daily tablets, at strengths of 10, 15, 20, 30, or 40 mg (20 to 240 mg daily), every 12 hours taken orally with water

    Number of subjects in period 1
    		Open label treatment
    Started
    155
    Completed
    122
    Not completed
    33
         Consent withdrawn by subject
    7
         Adverse event, non-fatal
    10
         Lost to follow-up
    1
         adminitrative reason
    10
         Lack of efficacy
    5

    Baseline characteristics

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

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 155 155
    Age categorical
    NA
    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)
    		 27 27
        Adolescents (12-17 years)
    		 128 128
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 13.7 ± 2.33 -
    Gender categorical
    Units: Subjects
        Female
    		 89 89
        Male
    		 66 66
    RAce/Ethnicity
    Units: Subjects
        White
    		 108 108
        Black or African American
    		 38 38
        Asian
    		 1 1
        Other
    		 8 8
    Subject analysis sets

    Subject analysis set title
    age group 6 to <12 years
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    patients with ages 6 to <12 years

    Subject analysis set title
    age group >= 12 to <=16
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Children with ages >= 12 to <=16

    Subject analysis sets values
    		 age group 6 to <12 years age group >= 12 to <=16
    Number of subjects
    27
    128
    Age categorical
    NA
    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)
    27
    0
        Adolescents (12-17 years)
    0
    128
        Adults (18-64 years)
    0
    0
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    9.6 ± 1.65
    14.5 ± 1.34
    Gender categorical
    Units: Subjects
        Female
    14
    75
        Male
    13
    53
    RAce/Ethnicity
    Units: Subjects
        White
    20
    88
        Black or African American
    7
    31
        Asian
    0
    1
        Other
    0
    8

    End points

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    End points reporting groups
    Reporting group title
    Open label treatment
    Reporting group description
    		 Twice Daily Oxycodone Hydrochloride Controlled-release Tablets

    Subject analysis set title
    age group 6 to <12 years
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    patients with ages 6 to <12 years

    Subject analysis set title
    age group >= 12 to <=16
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Children with ages >= 12 to <=16

    Primary: Number of participants with Adverse Events as a Measure of Safety

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    End point title
    		 Number of participants with Adverse Events as a Measure of Safety [1]
    End point description
    Safety assessments consisted of reports of AEs, Physical examinations, clinical laboratory tests results, vital signs measurements pulse oximetry (SpO2) and somnolence assessments. Safety variables were summarized descriptively within age group for the safety population. the safety population was the group of patients who received at least 1 dose of study drug during the study.
    End point type
    Primary
    End point timeframe
    Up to 4 weeks ( during the Study) and 7-10 days poststudy ( safety follow-up assessment)
    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 comparative inferential analysis is performed for the data from this open label study in which all patients received oxycodone HCI CR treatment. No adjustments for covariates are necessary for the analysis of this study. Data will be summarized overall and by age group where appropriate.
    End point values
    		 age group 6 to <12 years age group >= 12 to <=16
    Number of subjects analysed
    27
    128
    Units: Participants
        Serious adverse events
    5
    22
        All other adverse events in >=5% of patients
    13
    60
    No statistical analyses for this end point

    Secondary: Pain Right Now Assessment by patients aged 6 to < 12

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    End point title
    		 Pain Right Now Assessment by patients aged 6 to < 12
    End point description
    Pain right now was assessed by patients aged 6 to <12 years using the Faces of Pain Scale-Revised (FPS-R). the FPS-R is a horizontal row of 6 faces representing pain intensity, with "no hurt" at the far left and "hurts worst" at the far right; the 6 intensities are scored as 0, 2, 4, 6, 8 or 10 ( the patient was not shown the numbers associated with the faces). A score of 0 means no pain, and a 10 means very much pain. Pain rign now was assessed by the patient at screening, after the first dose, and , thereafter, twice daily during the AM and PM, approximately at the time of each ( morning an evening) dose of oxycodone HCI CR tablets during the study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 4
    End point values
    		 age group 6 to <12 years
    Number of subjects analysed
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline: number ( n)= 27
    4.44 ± 3.25
        Average during week 1: morning, n=25
    4.11 ± 2.674
        Average during week 1: evening, n=26
    4.07 ± 2.695
        Average during week 2: morning, n= 23
    3.66 ± 2.64
        Average during week 2, evening, n=22
    3.7 ± 2.686
        average during week 3: morning, n=17
    3.64 ± 2.579
        Average during week 3: evening, n=17
    3.76 ± 2.669
        Average during week 4: morning, n=14
    3.13 ± 2.569
        Average during week 4: evening, n=14
    3.42 ± 2.974
    No statistical analyses for this end point

    Secondary: Pain Right Now Assessment by Patients aged >=12 to <=16 years

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    End point title
    		 Pain Right Now Assessment by Patients aged >=12 to <=16 years
    End point description
    Pain right now was assessed by patients aged >=12 to <=16 years using a 100-mm visual analogic scale (VAS). the 100-mm line with 1 end marked "no pain" and the opposite end marked as "pain as bad as it could be". the patient was asked to make a mark on that line indicating his or her level of pain. the pain right now 100-mm VAS score was defined as the distance ( in mm) from the "no pain" end to the patient's mark. The scale is measured on a 100 mm line: a 0 means no pain and bigger numbers indicate more pain. Pain righ now was assessed by the patient at screening, after the first dose, and, thereafter, twice daily during the AM and PM, approximately at the time of each ( morning and evening) dose of oxycodone HCI CR tablets during the study treatment
    End point type
    Secondary
    End point timeframe
    Baseline to week 4
    End point values
    		 age group >= 12 to <=16
    Number of subjects analysed
    Units: units on a scale
    arithmetic mean (standard deviation)
        baseline, n= 126
    44.58 ± 28.291
        Average during week 1: morning, n=124
    40.38 ± 24.402
        Average during week 1: evening, n=124
    39.24 ± 23.301
        Average during week 2: morning, n=122
    34.49 ± 24.98
        Average during week 2: evening, n=122
    33.04 ± 24.778
        Average during week 3: morning, n=101
    32.56 ± 25.802
        Average during week 3: evening, n=88
    33.46 ± 24.639
        Average during week 4: morning, n= 53
    35.58 ± 27.177
        Average during week 4: evening, n= 50
    35.3 ± 26.711
    No statistical analyses for this end point

    Secondary: Use of supplemental Pain Medication

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    End point title
    		 Use of supplemental Pain Medication
    End point description
    Supplemental opioid and nonopioid pain medications were permitted during the study as deemed appropriate by the investigator. the dose of supplemental analgesic medication allowed was at the discretion of the investigator and within appropriate dose ranges for age and weight.
    End point type
    Secondary
    End point timeframe
    Baseline to week 4
    End point values
    		 age group 6 to <12 years age group >= 12 to <=16
    Number of subjects analysed
    27
    128
    Units: participants
        Any supplemental pain medication
    24
    112
        Any opioid supplemental pain medication
    21
    93
        Any nonopioid supplemental pain medication
    17
    75
    No statistical analyses for this end point

    Secondary: Parent/Caregiver-Assessed Global Impression of Change ( PGIC)

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    End point title
    		 Parent/Caregiver-Assessed Global Impression of Change ( PGIC)
    End point description
    The PGIC rating score variable was collected on a 7-point scale ranging from 1 to 7 ( where 1=very much improved; and 7=very much worse). The PGIC is designed to assess overall satisfaction with the treatment. The number and percent of parent/caregivers reporting each category of PGIC response at the final visit was summarized for the safety population within age group
    End point type
    Secondary
    End point timeframe
    Baseline to week 4 or early discontinuation
    End point values
    		 age group 6 to <12 years age group >= 12 to <=16
    Number of subjects analysed
    25
    115
    Units: participants
        1=very much improved
    10
    42
        2= much improved
    8
    51
        3=minimally improved
    3
    15
        4=no change
    3
    5
        5=minimally worse
    0
    1
        6=much worse
    0
    0
        7=very much worse
    1
    1
    No statistical analyses for this end point

    Secondary: Parent/Caregiver assessed Functional Disability Inventory (FDI) for Patients aged 6 to <12 years

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    End point title
    		 Parent/Caregiver assessed Functional Disability Inventory (FDI) for Patients aged 6 to <12 years
    End point description
    The FDI is a validated tool used to evaluate the degree to which children have reduced phyisical and psycosocial functioning because of their pain difficulties in the previous 2 weeks. The FDI comprises 15 items. Responses to each item were scored using a 5-point Likert scale. the individual scores are: (0) no trouble, (1) a little trouble, (2) some trouble, (3) a lot of trouble, and (4) impossible. A total score (ranging from 0 to 60) for the 15 items was calculated, with lower scores indicating less functional disability. The FDI was performed by the parent/caregiver
    End point type
    Secondary
    End point timeframe
    Baseline to week 4
    End point values
    		 age group 6 to <12 years
    Number of subjects analysed
    27
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline: n=26
    27.1 ± 13.06
        Week 4: n=25
    23 ± 13.32
    No statistical analyses for this end point

    Secondary: Parent/Caregiver Assessed Functional Disability Inventory (FDI) for Patients aged >=12 to <= 16 years

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    End point title
    		 Parent/Caregiver Assessed Functional Disability Inventory (FDI) for Patients aged >=12 to <= 16 years
    End point description
    The FDI is a validated tool used to evaluate the degree to which children have reduced physical and psycosocial functioning because of their pain difficulties in the previous 2 weks. The FDI comprises 15 items. Responses to each item were scored using a 5- point Likert scale. The individual scores are (0) no trouble, (1) a little trouble, (2) some trouble, (3) a lot of trouble, and (4) impossible. A total score ( ranging from 0 to 60) for the 15 items was calculated, with lower scores indicating less functional disability. The FDI was performed by the parent/caregiver
    End point type
    Secondary
    End point timeframe
    Baseline to week 4
    End point values
    		 age group >= 12 to <=16
    Number of subjects analysed
    128
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline: n=127
    23.2 ± 17.47
        Week 4: n=119
    20.4 ± 12.65
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) were reported from start of study participation through the period beyond study completion
    Adverse event reporting additional description
    AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Age group 6 to < 12 years
    Reporting group description
    		 Children 6 to < 12 years of age

    Reporting group title
    Age group >=12 to <=16
    Reporting group description
    		 Children >=12 to <=16 years of age

    Serious adverse events
    		 Age group 6 to < 12 years Age group >=12 to <=16
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 27 (18.52%)
    22 / 128 (17.19%)
         number of deaths (all causes)
    2
    2
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vascular disorders
    Axillary vein thrombosis
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 27 (7.41%)
    5 / 128 (3.91%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 128 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory disorder
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Injury, poisoning and procedural complications
    Seroma
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 128 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Sickle cell anaemia with crisis
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Coma
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Headache
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 128 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Balance disorder
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion in childhood
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lethargy
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status migrainosus
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 128 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 27 (3.70%)
    4 / 128 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Diplopia
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 128 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pacreatitis acute
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis clostridial
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural cellulitis
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Age group 6 to < 12 years Age group >=12 to <=16
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 27 (48.15%)
    60 / 128 (46.88%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 27 (11.11%)
    17 / 128 (13.28%)
         occurrences all number
    2
    19
    Dizziness
         subjects affected / exposed
    0 / 27 (0.00%)
    11 / 128 (8.59%)
         occurrences all number
    0
    12
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    5 / 27 (18.52%)
    8 / 128 (6.25%)
         occurrences all number
    6
    12
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    6 / 27 (22.22%)
    26 / 128 (20.31%)
         occurrences all number
    12
    51
    Nausea
         subjects affected / exposed
    3 / 27 (11.11%)
    20 / 128 (15.63%)
         occurrences all number
    6
    28
    Constipation
         subjects affected / exposed
    4 / 27 (14.81%)
    12 / 128 (9.38%)
         occurrences all number
    4
    12
    Skin and subcutaneous tissue disorders
    pruritus
         subjects affected / exposed
    3 / 27 (11.11%)
    7 / 128 (5.47%)
         occurrences all number
    3
    7

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Jul 2010
    -Reference to collect all opioid supplemental medication throughout the protocol was revised to include nonopioid supplemental medication since patients were allowed to use nonopioid supplemental medication for pain throughout the study. - Requirements for uptitration based on supplemental use was revised to have these criteria determined based on the investigator's judgment. - Collection of PCA doses and attempts was added to the protocol. - Method of obtaining temperature (oral) was deleted and a specific method was not specified. - Full analysis populations were made consistent between the synopsis and body of the protocol. - Typos/inconsistencies were corrected throughout the protocol.
    27 Jan 2011
    - Added the collection of sparse PK sampling. - Added additional somnolence assessments for uptitration for additional safety measures. - Added additional conversion factors for fentanyl. - Added a phone call to occur every 48 hours for outpatients to collect safety information. - Added more detailed study drug dosing procedures clarifying how the study drug should be administered. - Added a bowel preparation to be performed before the start of dosing. - Added and revised additional inclusion and exclusion criteria: Clarified definition of opioid tolerant patient; postoperative patients cannot be enrolled until at least 120 hours after surgery; exclusion criteria regarding CYP3A4 inhibitors and the use of epidurals prior to study drug administration were clarified to make less stringent. - Revised laboratory requirements for day 1; clarified that local laboratory may be used for eligibility. - Added oxycodone as a prohibited supplemental analgesic medication since it would interfere with the analysis of study drug. - Increased the sample size to 135 patients in order to meet current minimum requirements for the number of pediatric patients to be exposed to study drug. - Changed opioid experienced to opioid tolerant throughout the protoco
    24 Jan 2012
    -The increase in the number of patients from 135 to 154 was made to account for the total number of patients required to be exposed to oxycodone for the evaluation of the safety of oxycodone in children, including all studies in our program; - For those patients who had undergone surgery, the postoperative criterion of waiting at least 120 hours from surgery to the start of study drug dosing was revised to at least 5 days. - language was included in the exclusion criteria of the protocol such that patients who had underlying gastrointestinal disorder predisposing them to obstruction were not enrolled in the study. -A washout period of at least 4 days for patient takin methadone prior to enroll into the study. - A conversion factor was added to convert the incoming dose of tramadol to oxycodone. -Recruitment of a urine pregnancy test, without the option of a serum pregnancy test, was added to visit 3 for patients who completed the OTR3001 study and were being screened to participate in the OTR3002 extension -The screening window was changed from up to 48 hours to up to 72 hours prior to Day 1 to allow adequate time for availability of laboratory results for review at the time that dosing initiation was planned. - Values used to define ranges of bilirubin displayed in listings and ranges of AST and ALT displayed in tables and listings were modified to be more inclusive and provide information on more patients with potentially clinically significant liver function test abnormalities. - Specified the volume (2 mL) of the tubes used for PK sampling. -Language for reporting of clinical supplies product complaints (protocol section 9.4.5) was updated to reflect the current process -Section 5.2 of the protocol was updated to reflect the most current ICH/GCP guidelines
    11 Jun 2012
    If a patient had difficulty getting to the site for a study visit, these visits might be conducted at a patient's home if the principal investigator deemed this to be appropriate based on the patient's medical status
    23 Jan 2014
    -A population PK analysis was conducted to determine whether additional PK samples would be required from the remaining patients to be enrolled into OTR3001. For this analysis, the final population PK data set included 255 pediatric patients with ages ranging from newborn to 16 years and weights from 2.4 to 112 kg. There were 99 patients included from OTR3001. - The major conclusions of these analyses were: o The simulation based model evaluation shows a predictive ability for both pediatric and multiple dose adult oxycodone PK. o The results of this analysis demonstrated that exposures (Area under the curve at steady state [AUCss], maximum concentration in the dosing interval [Cmax], minimum concentration in the dosing interval [Cmin]) in 2 pediatric subgroups (ages >6 to <12 and ages �� 12 to �� 16 years) were similar by graphical comparison when the exposure was calculated both at the time of first dose and time of last dose. o At a weight-based oxycodone dose of 0.2 mg/kg, expected adult (age >16 years) exposure (AUCss) under the model was similar to pediatric (age 6 to 16 years) AUCss, with pediatric patients doses as in the clinical study. - Based on these results, as described above, the decision was made to discontinue further collection of PK samples for this study; therefore, the PK sampling requirement was removed from the protocol.
    12 Feb 2014
    -A population PK analysis was conducted to determine whether additional PKsamples would be required from the remaining patients to be enrolled into TR3001. For this analysis, the final population PK data set included 255 pediatric patients with ages ranging from newborn to 16 years and weights from 2.4 to 112 kg. There were 99 patients included from OTR3001. - The major conclusions of these analyses were: o The simulation based model evaluation shows a predictive ability for both pediatric and multiple dose adult oxycodone PK. o The results of this analysis demonstrated that exposures (AUCss, Cmax, Cmin) in 2 pediatric subgroups (ages >6 to <12 and ages �� 12 to �� 16 years) were similar by graphical comparison when the exposure was calculated both at the time of first dose and time of last dose. o At a weight-based oxycodone dose of 0.2 mg/kg, expected adult (age >16 years) exposure (AUCss) under the model was similar to pediatric (age 6 to 16 years) AUCss, with pediatric patients’ doses as in the clinical study. - Based on these results, as described above, the decision was made to discontinue - further collection of PK samples for this study; therefore, the PK sampling requirement was removed from the protocol

    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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