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    Clinical Trial Results:
    Open-label, single-arm, flexible dosing, Phase III trial, with oral tapentadol prolonged release (PR) in subjects with chronic malignant tumor-related pain who have completed the Maintenance Period of the KF 5503/15 trial.

    Summary
    EudraCT number
    		 2009-013291-46
    Trial protocol
    		 CZ   AT   ES   HU   FR   BG   RO  
    Global end of trial date
    08 May 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Feb 2016
    First version publication date
    19 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    KF5503/52
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01264887
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Grünenthal GmbH: 168935
    Sponsors
    Sponsor organisation name
    Grünenthal GmbH
    Sponsor organisation address
    Zieglerstr. 6, Aachen, Germany, 52099
    Public contact
    Grünenthal Clinical Trial Helpdesk, Grünenthal Clinical Trial Helpdesk, 49 241 569 3223 , Clinical-Trials@grunenthal.com
    Scientific contact
    Grünenthal Clinical Trial Helpdesk, Grünenthal GmbH, 49 241 569 3223 , Clinical-Trials@grunenthal.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Apr 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 May 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    08 May 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The characterization of the long term safety profile of tapentadol PR at doses ranging from 100 mg to 250 mg taken twice daily, in patients with malignant tumor-related pain
    Protection of trial subjects
    The trial was conducted according to ICH-GCP guidelines, the applicable local laws, and in accordance with the ethical principles that have their origins in the Declaration of Helsinki. Regulatory authorities were notified of the trial and amendments as required by national regulations, and where necessary relevant authorization was obtained. Furthermore, the competent authorities were notified of this trial in accordance with national requirements.
    Background therapy
    		 The use of concomitant medication was reported by all subjects. The participating sites could prescribe standard medications, for example, for breakthrough pain, nausea, vomiting, and constipation. These medications were recorded in the case report form. For subjects on tapentadol treatment, caution was to be exercised if concomitant drug administration of strong enzyme inducing drugs (e.g., rifampicin, phenobarbital, St John’s Wort [hypericum perforatum]) started or stopped, since this may have led to decreased efficacy or risk for adverse effects, respectively. Subjects had to adhere to the following precautions: • As with other centrally acting analgesics, subjects were to be advised not to drink alcohol or take other central nervous system suppressants concomitantly with tapentadol PR. • Because tapentadol may cause symptoms typical of a centrally acting analgesic, such as fatigue, dizziness, nausea, or vertigo, subjects were to be advised that operating machinery or driving a vehicle may be dangerous. Monoamine oxidase inhibitors were prohibited during the trial. Radiotherapy and treatment by a pain-inducing chemotherapy protocol (as judged by the investigator) were forbidden for all patients for 30 days prior to enrollment and during the trial. However, it was up to the evaluation of the investigator if the chemotherapy was pain-inducing and so, if a potentially pain-inducing substance was well tolerated in previous chemotherapy cycles, the patient could be included even if a new cycle with this substance was planned during the trial.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Mar 2011
    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
    Poland: 5
    Country: Number of subjects enrolled
    Romania: 5
    Country: Number of subjects enrolled
    Bulgaria: 2
    Country: Number of subjects enrolled
    Hungary: 4
    Country: Number of subjects enrolled
    Serbia: 6
    Country: Number of subjects enrolled
    Moldova, Republic of: 6
    Country: Number of subjects enrolled
    Russian Federation: 3
    Worldwide total number of subjects
    31
    EEA total number of subjects
    16
    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)
    25
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First subject was enrolled on the 03 March 2011 and the last subject completed the trial on the 08 May 2014. Subjects had to have completed the Maintenance period in the KF5503/15 trial to enter the KF5503/52 trial.

    Pre-assignment
    Screening details
    		 Subjects directly entered the KF5503/52 trial from the KF5503/15 trial, i.e., within 7 days of the final visit in the KF5503/15 trial. Alternatively subjects with a gap of more than 7 days and less than 24 weeks had additional visit to assess eligibility into the KF5503/52 trial.

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

    Arms
    Arm title
    		 Tapentadol prolonged release
    Arm description
    		 Subjects received doses between 100 to 250 mg tapentadol twice daily (50 and 100 mg tablets to be dispensed). A flexible titration to achieve sufficient pain relief to continue with effective analgesia for as long as the subject tolerates and wished to continue treatment was permited.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tapentadol prolonged release
    Investigational medicinal product code
    CG5503
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The medication was supplied in blister cards suitable for 10 days intake allowing dose adjustment from 100 mg taken twice daily to 250 mg taken twice daily.

    Number of subjects in period 1
    		Tapentadol prolonged release
    Started
    31
    Completed
    2
    Not completed
    29
         Adverse event, serious fatal
    7
         Consent withdrawn by subject
    6
         Physician decision
    4
         Adverse event, non-fatal
    5
         Not specified
    2
         Lack of efficacy
    5

    Baseline characteristics

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

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 31 31
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 25 25
        From 65-84 years
    		 6 6
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55.8 ( 11.91 ) -
    Gender categorical
    Units: Subjects
        Female
    		 16 16
        Male
    		 15 15
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 64.6 ( 16.45 ) -
    Height
    Units: meter
        arithmetic mean (standard deviation)
    		 165 ( 10.24 ) -
    Body Mass Index
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    		 23.6 ( 4.79 ) -

    End points

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    End points reporting groups
    Reporting group title
    Tapentadol prolonged release
    Reporting group description
    		 Subjects received doses between 100 to 250 mg tapentadol twice daily (50 and 100 mg tablets to be dispensed). A flexible titration to achieve sufficient pain relief to continue with effective analgesia for as long as the subject tolerates and wished to continue treatment was permited.

    Primary: Severity of Adverse Events

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    End point title
    		 Severity of Adverse Events [1]
    End point description
    A treatment emergent adverse event (TEAE) was any adverse event that occurred after the first administration of IMP, or any pre-existing adverse event that worsened (e.g., in intensity, frequency, or quality) after the first administration of IMP, up to 3 days for serious adverse events and up to 30 days for deaths after last intake of tapentadol prolonged release. The clinical “intensity” of adverse event were classified as: Mild: signs and symptoms which can be easily tolerated. Symptoms could be ignored and disappeared when the participant is distracted. Moderate: symptoms caused discomfort but were tolerable, they could not be ignored and affect concentration. Severe: symptoms affected the usual daily activity.
    End point type
    Primary
    End point timeframe
    Day 1; up to 144 weeks
    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: The primary endpoints for this trial are the frequency and severity of AEs at recorded the visits during the Open-label Treatment Period and the Follow-Up Visit. These will be described to assess long term safety and no statistical testing or inference is planned on this primary objective.
    End point values
    		 Tapentadol prolonged release
    Number of subjects analysed
    31
    Units: Subjects
        mild intensity
    3
        moderate intensity
    15
        severe intensity
    12
    No statistical analyses for this end point

    Primary: Relatedness Assessment of Treatment Emergent Adverse Events

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    End point title
    		 Relatedness Assessment of Treatment Emergent Adverse Events [2]
    End point description
    Participant-based analysis of treatment emergent adverse events (TEAEs) regarding the relationship to the study drug (tapentadol). The TEAEs were reported by the participants or were captured by the investigator. The relationship was rated by the investigator. The categorization of relatedness into one of the two categories was based on the following: Related included “possible”, “probable/likely”, and “certain”; whilst unrelated treatment emergent adverse events include those rated by the investigator as “unlikely”, “conditional/unclassified”, “un-assessable/unclassifiable”, and “not related”.
    End point type
    Primary
    End point timeframe
    Day 1; up to 144 weeks
    Notes
    [2] - 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: The primary endpoints for this trial are the frequency and severity of AEs at recorded the visits during the Open-label Treatment Period and the Follow-Up Visit. These will be described to assess long term safety and no statistical testing or inference is planned on this primary objective.
    End point values
    		 Tapentadol prolonged release
    Number of subjects analysed
    31
    Units: Subjects
        No Treatment Emergent Adverse Events
    1
        All Treatment Emergent Adverse Events
    30
        Investigator-rated Related
    6
        Investigator-rated Not Related
    24
    No statistical analyses for this end point

    Primary: Countermeasures Taken Due to Treatment Emergent Adverse Events

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    End point title
    		 Countermeasures Taken Due to Treatment Emergent Adverse Events [3]
    End point description
    Participant-based analysis of treatment emergent adverse events (TEAEs) regarding countermeasure to the study drug (tapentadol). The TEAEs were reported by the participants or were captured by the investigator. The countermeasure taken by the investigator were reported.
    End point type
    Primary
    End point timeframe
    Day 1; up to 144 weeks
    Notes
    [3] - 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: The primary endpoints for this trial are the frequency and severity of AEs at recorded the visits during the Open-label Treatment Period and the Follow-Up Visit. These will be described to assess long term safety and no statistical testing or inference is planned on this primary objective.
    End point values
    		 Tapentadol prolonged release
    Number of subjects analysed
    31
    Units: Subjects
        All Treatment Emergent Events
    30
        No Treatment Emergent Adverse Events
    1
        No countermeasures taken
    5
        Countermeasures with Medication
    17
        Trial Discontinued Countermeasure
    6
        Other Countermeasure due to Somnolence
    1
        Other Countermeasure due to Migraine
    1
    No statistical analyses for this end point

    Secondary: Assess Consumption of Tapentadol During Long Term Use

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    End point title
    		 Assess Consumption of Tapentadol During Long Term Use
    End point description
    All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment. Summary of the modal total daily dose during the treatment period. The modal dose was based on assessment of the consecutive morning and evening intake amounts on each day and evaluation of the total daily dose. No participant received more than 500 mg per day.
    End point type
    Secondary
    End point timeframe
    Day 1; up to 144 weeks
    End point values
    		 Tapentadol prolonged release
    Number of subjects analysed
    31
    Units: Subjects
        less than 200 mg/day
    0
        200 to less than 250 mg/day
    3
        250 to less than 300 mg/day
    1
        300 to less than 350 mg/day
    8
        350 to less than 400 mg/day
    0
        400 to less than 450 mg/day
    11
        450 to less than 500 mg/day
    0
        500 mg/day
    8
    No statistical analyses for this end point

    Secondary: Tapentadol Prolonged Release Exposure

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    End point title
    		 Tapentadol Prolonged Release Exposure
    End point description
    The number of days that participants took tapentadol prolonged release. The extent of exposure was categorized into 2 periods, less than 90 days and more than 90 days (up to 144 weeks).
    End point type
    Secondary
    End point timeframe
    Day 1; up to 144 weeks
    End point values
    		 Tapentadol prolonged release
    Number of subjects analysed
    31
    Units: Subjects
        Tapentadol exposure from 1 to 90 days
    11
        Tapentadol exposure for more than 90 days
    20
    No statistical analyses for this end point

    Other pre-specified: Average Pain Intensity (Over a Twelve-week Period)

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    End point title
    		 Average Pain Intensity (Over a Twelve-week Period)
    End point description
    The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Average pain intensity score is the average of pain experienced for previous 24 hours as rated on an 11-point NRS at each visit. Calculations are based on 3 consecutive planned (at 4-weekly intervals) visits.
    End point type
    Other pre-specified
    End point timeframe
    Day 1; up to Week 144
    End point values
    		 Tapentadol prolonged release
    Number of subjects analysed
    31
    Units: 11-point Numerical Rating Scale (NRS)
    arithmetic mean (standard deviation)
        Baseline (N=31)
    3.3 ( 1.79 )
        Week 1 to 12 (N =30)
    3.1 ( 1.95 )
        Week 13 to 24 (N=20)
    3.1 ( 2.51 )
        Week 25 to 36 (N=14)
    2.1 ( 1.57 )
        Week 37 to 48 (N=13)
    2 ( 1.71 )
        Week 49 to 60 (N=11)
    2 ( 1.78 )
        Week 61 to 72 (N=9)
    2 ( 1.61 )
        Week 73 to 84 (N=8)
    2.4 ( 1.97 )
        Week 85 to 96 (N=7)
    3.1 ( 3.16 )
        Week 97 to 108 (N=6)
    3.1 ( 3.76 )
        Week 109 to 120 (N=3)
    3.3 ( 2.52 )
        Week 121 to 132 (N=1)
    1 ( 0 )
        Week 133 to 144 (N=1)
    1 ( 0 )
    No statistical analyses for this end point

    Other pre-specified: Average Daily Total Tapentadol Prolonged Release Dose

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    End point title
    		 Average Daily Total Tapentadol Prolonged Release Dose
    End point description
    The Total Daily Dose (TDD) on any given day is the sum of the morning and evening intake amounts. The average TDD is an individuals average over the trial period.
    End point type
    Other pre-specified
    End point timeframe
    Day 1; up to 144 weeks
    End point values
    		 Tapentadol prolonged release
    Number of subjects analysed
    31
    Units: milligram(s)/24 hours
    arithmetic mean (standard deviation)
        Average Daily Total Tapentadol PR dose
    360 ( 91.21 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 (Day of first open-label dose, i.e. first tapentadol PR intake during the treatment phase, up to 30 days after last intake of open-label tapentadol prolonged release) to 144 weeks.
    Adverse event reporting additional description
    A treatment emergent adverse event is defined as any adverse event that occurred for the first time on or after the first intake of tapentadol PR during treatment, or adverse event started prior to the first dose and worsened in intensity after the first tapentadol PR intake during the treatment phase.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Tapentadol prolonged release
    Reporting group description
    		 Subjects received doses between 100 to 250 mg tapentadol twice daily (50 and 100 mg tablets to be dispensed). A flexible titration to achieve sufficient pain relief to continue with effective analgesia for as long as the subject tolerates and wished to continue treatment was permited.

    Serious adverse events
    		 Tapentadol prolonged release
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 31 (45.16%)
         number of deaths (all causes)
    11
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Malignant neoplasm progression
         subjects affected / exposed
    9 / 31 (29.03%)
         occurrences causally related to treatment / all
    0 / 9
         deaths causally related to treatment / all
    0 / 8
    Metastases to lung
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardiac failure
    Additional description: Post-treatment adverse event leading to death 30 days after the last administration of tapentadol prolonged release. The subject did not have another serious adverse event.
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
    Additional description: Investigator indicated that the progression of the underlying malignancy (lung carcinoma) was associated with the hypoxia. Treatment emergent event leading to death.
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Renal and urinary disorders
    Azotaemia
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Tapentadol prolonged release
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 31 (96.77%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    3
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to bone
         subjects affected / exposed
    4 / 31 (12.90%)
         occurrences all number
    4
    Malignant neoplasm progression
         subjects affected / exposed
    5 / 31 (16.13%)
         occurrences all number
    14
    Neoplasm progression
         subjects affected / exposed
    3 / 31 (9.68%)
         occurrences all number
    3
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    3 / 31 (9.68%)
         occurrences all number
    3
    Sinus tachycardia
         subjects affected / exposed
    3 / 31 (9.68%)
         occurrences all number
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 31 (9.68%)
         occurrences all number
    5
    Headache
         subjects affected / exposed
    3 / 31 (9.68%)
         occurrences all number
    3
    Somnolence
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 31 (16.13%)
         occurrences all number
    6
    Lymphadenopathy
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2
    Thrombocytopenia
         subjects affected / exposed
    3 / 31 (9.68%)
         occurrences all number
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2
    General physical health deterioration
         subjects affected / exposed
    3 / 31 (9.68%)
         occurrences all number
    3
    Pyrexia
         subjects affected / exposed
    4 / 31 (12.90%)
         occurrences all number
    6
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2
    Ascites
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    7
    Constipation
         subjects affected / exposed
    4 / 31 (12.90%)
         occurrences all number
    4
    Nausea
         subjects affected / exposed
    9 / 31 (29.03%)
         occurrences all number
    10
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    4
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Pathological fracture
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    3
    Urinary tract infection
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Hypoalbuminaemia
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Jan 2011
    Amendment 1: The protocol was updated with information relating to concomitant medication.
    02 Oct 2012
    Amendment 2: Changes in sponsor staff.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    08 May 2014
    The trial was stopped for administrative reasons. Three years after trial initiation 2 participants were in the trial and to permit analysis and reporting the sponsor decided to terminate the trial.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    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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