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    Clinical Trial Results:
    An open-label extension study for patients with severe chronic low back pain or severe chronic pain due to knee osteoarthritis who have completed any of the previous phase IIIb trials with tapentadol hydrochloride, KF5503/42, KF5503/44 or KF5503/45.

    Summary
    EudraCT number
    		 2009-017470-20
    Trial protocol
    		 FR  
    Global end of trial date
    23 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 May 2016
    First version publication date
    29 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GRT-CG5503-2009-02-FR
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Laboratoires Grünenthal
    Sponsor organisation address
    Immeuble Eureka - 19 rue Ernest Renan, Nanterre Cedex, France, CS90001 - 92024
    Public contact
    Grünenthal Clinical Trial Helpdesk, Grünenthal GmbH, +49 2415693223, clinical-trials@grunenthal.com
    Scientific contact
    Grünenthal Clinical Trial Helpdesk, Grünenthal GmbH, +49 2415693223, 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
    18 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The principal objective is to offer treatment with tapentadol hydrochloride to patients who have completed clinical trials KF5503/42, KF5503/44 or KF5503/45, and who could benefit from continued analgesic therapy with tapentadol.
    Protection of trial subjects
    The trial was conducted according to ICH-GCP guidelines, the applicable French laws, and in accordance with the ethical principles that have their origins in the Declaration of Helsinki. Regulatory and competent authorities were notified of the trial and relevant authorization was obtained.
    Background therapy
    		 Three patients were included in this open-label extension. These patients were previously included in the KF 5503/44 trial: "An evaluation of the effectiveness and tolerability of tapentadol hydrochloride prolonged release, and tapentadol hydrochloride immediate release on demand, in patients with uncontrolled severe chronic nociceptive, mixed or neuropathic low back pain taking either WHO Step I or Step II analgesics or no regular analgesics".
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Jun 2010
    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
    France: 3
    Worldwide total number of subjects
    3
    EEA total number of subjects
    3
    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)
    3
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients who had completed one of the clinical trials: KF5503/42, KF5503/44 or KF5503/45 were eligible to continue in this trial. The trial consisted of 3 parts for subjects: an enrollment visit, an open-label treatment phase and a final visit. The enrollment visit coincided with the completion of the maintenance period of the previous trial.

    Pre-assignment
    Screening details
    		 French patients who benefited from tapentadol treatment and who had completed one of the clinical trials: KF5503/42, KF5503/44 or KF5503/45 were offered the opportunity to continue therapy on tapentadol. The first-patient-in was on 23 June 2010 and the last-patient-out was on the 23 April 2014.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    The primary objective was to offer treatment with Tapentadol hydrochloride to patients who had completed clinical trials KF5503/42, KF5503/44 or KF5503/45, and who could have benefited from continued analgesic therapy with Tapentadol.

    Arms
    Arm title
    		 Tapentadol Prolonged Release
    Arm description
    		 All patients maintained the same dose of tapentadol hydrochloride PR with which they have completed the preceding protocol, resulting from the dose titration and stabilization period. The tapentadol hydrochloride PR dose may have been adjusted under certain circumstances, and following an established procedure. All dosage adjustments must have been made at a patient visit to the study centre.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tapentadol
    Investigational medicinal product code
    CG5503
    Other name
    Pharmaceutical forms
    Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    During this open-label extension trial the minimal and maximal total daily doses of Tapentadol were from 300 to 600 mg.

    Number of subjects in period 1
    		Tapentadol Prolonged Release
    Started
    3
    Completed
    2
    Not completed
    1
         multiple reasons including pain intensity increase
    1

    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
    		 3 3
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 3 3
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 44 (43 to 47) -
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 1 1
    Patient Global Impression of Change at Baseline
    In the Patient Global Impression of Change (PGIC) the subject indicated the perceived change over the treatment period in the previous trial. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as “very much improved,” “much improved,” “minimally improved,” “no change,” “minimally worse,” “much worse,” or “very much worse.”
    Units: Subjects
        much improved
    		 1 1
        very much improved
    		 1 1
        minimally improved
    		 1 1
    Height
    Units: meter
        arithmetic mean (full range (min-max))
    		 1.69 (1.57 to 1.86) -
    Weight
    Units: kilogram(s)
        arithmetic mean (full range (min-max))
    		 62 (55 to 73) -
    Body Mass Index (BMI)
    Units: kilogram(s)/square meter
        arithmetic mean (full range (min-max))
    		 21.66 (21.1 to 22.31) -
    Pain Intensity at Baseline
    The recalled average pain intensity score on the NRS-3 was assessed using the 11-point NRS. This scale recalled the average pain intensity during the last 3 days. Pain intensity as evaluated by the 11-point NRS-3 scale at the visit. The patients have been asked to answer the following questions "Please rate your pain by circling the one number that best describes your current pain" wher 0 (is no pain) and 10 (indicated pain as bad as you can imagine).
    Units: unit(s)
        arithmetic mean (full range (min-max))
    		 4.33 (0 to 7) -
    Systolic Blood Pressure
    Units: mmHg
        arithmetic mean (full range (min-max))
    		 117.67 (111 to 124) -
    Diastolic Blood Pressure
    Units: mmHg
        arithmetic mean (full range (min-max))
    		 65.33 (62 to 68) -
    Heart Rate
    Units: beat(s) per minute
        arithmetic mean (full range (min-max))
    		 67.33 (62 to 74) -

    End points

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    End points reporting groups
    Reporting group title
    Tapentadol Prolonged Release
    Reporting group description
    		 All patients maintained the same dose of tapentadol hydrochloride PR with which they have completed the preceding protocol, resulting from the dose titration and stabilization period. The tapentadol hydrochloride PR dose may have been adjusted under certain circumstances, and following an established procedure. All dosage adjustments must have been made at a patient visit to the study centre.

    Primary: Medical and ethical reasons

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    End point title
    		 Medical and ethical reasons [1]
    End point description
    Given the nature of the study, only a descriptive analysis was planned and no primary efficacy criterion or endpoint was defined. The primary objective ot this open-label extension was to ofter, for medical and ethical reasons, a treatment with tapentadol hydrochloride to patients who had completed clinical trials KF5503/42, KF5503/44 or KF5503/45, and who could have benefited from continued analgesic therapy with tapentadol.
    End point type
    Primary
    End point timeframe
    Baseline Visit (Day 1)
    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: Because only 3 patients were enrolled, the analyses planned in the protocol could not be performed.
    End point values
    		 Tapentadol Prolonged Release
    Number of subjects analysed
    3
    Units: patient(s)
        number (not applicable)
    3
    No statistical analyses for this end point

    Other pre-specified: Pain intensity NRS-3

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    End point title
    		 Pain intensity NRS-3
    End point description
    The recalled average pain intensity score on the NRS-3 was assessed using the 11-point NRS. This scale recalled the average pain intensity during the last 3 days. Pain intensity as evaluated by the 11-point NRS-3 scale at the visit. The patients have been asked to answer the following questions "Please rate your pain by circling the one number that best describes your current pain" wher 0 (is no pain) and 10 (indicated pain as bad as you can imagine).
    End point type
    Other pre-specified
    End point timeframe
    Assessed at baseline, 4 weeks later and then at 8 weekly intervals up to 180 weeks after baseline.
    End point values
    		 Tapentadol Prolonged Release
    Number of subjects analysed
    3
    Units: unit(s)
    median (full range (min-max))
        Patient A
    6 (4 to 7)
        Patient B
    1 (0 to 7)
        Patient C
    6 (4 to 8)
    No statistical analyses for this end point

    Other pre-specified: Patient Global Impressions of Change (PGIC) at end of treatment

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    End point title
    		 Patient Global Impressions of Change (PGIC) at end of treatment
    End point description
    In the Patient Global Impression of Change (PGIC) the subject indicated the perceived change over the treatment period. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as “very much improved,” “much improved,” “minimally improved,” “no change,” “minimally worse,” “much worse,” or “very much worse.”
    End point type
    Other pre-specified
    End point timeframe
    End of Study Visit (Week 20, 200 weeks and up to 208 weeks).
    End point values
    		 Tapentadol Prolonged Release
    Number of subjects analysed
    3
    Units: patient(s)
        Very much improved
    1
        Much improved
    1
        Minimally improved
    1
    No statistical analyses for this end point

    Other pre-specified: Clinician Global Impression of Change (CGIC) at end of treatment

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    End point title
    		 Clinician Global Impression of Change (CGIC) at end of treatment
    End point description
    The CGIC was chosen as a complementary assessment of efficacy. In the Clinician Global Impression of Change (CGIC) the investigator rates the perceived change for the patient over the treatment period. CGIC uses the 7 point scale depicting a clinician's rating of overall improvement. Patients rate their change as “very much improved,” “much improved,” “minimally improved,” “no change,” “minimally worse,” “much worse,” or “very much worse.”
    End point type
    Other pre-specified
    End point timeframe
    End of Study Visit (Week 20, 200 weeks and up to 208 weeks).
    End point values
    		 Tapentadol Prolonged Release
    Number of subjects analysed
    3
    Units: patients
        Very much improved
    1
        Much improved
    1
        Minimally improved
    1
    No statistical analyses for this end point

    Other pre-specified: Mean Daily Dose of Tapentadol Prolonged Release

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    End point title
    		 Mean Daily Dose of Tapentadol Prolonged Release
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Baseline Visit (Day 1) to End of Study Visit (Week 20, 200 weeks and up to 208 weeks).
    End point values
    		 Tapentadol Prolonged Release
    Number of subjects analysed
    3
    Units: milligram(s)/24 hours
        arithmetic mean (full range (min-max))
    441.76 (387.9 to 453.04)
    No statistical analyses for this end point

    Other pre-specified: Mean Daily Dose of Tapentadol Immediate Release

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    End point title
    		 Mean Daily Dose of Tapentadol Immediate Release
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Baseline Visit (Day 1) to End of Study Visit (Week 20, 200 weeks and up to 208 weeks).
    End point values
    		 Tapentadol Prolonged Release
    Number of subjects analysed
    3
    Units: milligram(s)/24 hours
        arithmetic mean (full range (min-max))
    3.99 (3.5 to 4.3)
    No statistical analyses for this end point

    Other pre-specified: Concomitant medications during the trial

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    End point title
    		 Concomitant medications during the trial
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Baseline Visit (Day 1) to End of Study Visit (Week 20, 200 weeks and up to 208 weeks).
    End point values
    		 Tapentadol Prolonged Release
    Number of subjects analysed
    3
    Units: patient(s)
        increase in venlafaxine dose
    1
        alprazolam started
    1
        single local lidocaine infiltration
    1
        tramadol prolonged release
    1
        tramadol-paracetamol combination
    1
        naproxen
    1
        paracetamol
    1
        amoxicillin
    1
        magnesium-vitamin B6
    1
    No statistical analyses for this end point

    Other pre-specified: Systolic Blood Pressure

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    End point title
    		 Systolic Blood Pressure
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Baseline Visit (Day 1) to End of Study Visit (Week 20, 200 weeks and up to 208 weeks). Assessed at baseline, 4 weeks later and then at 8 weekly intervals up to 208 weeks after baseline.
    End point values
    		 Tapentadol Prolonged Release
    Number of subjects analysed
    3
    Units: mmHg
    arithmetic mean (standard deviation)
        Patient A
    116.7 ± 7.7
        Patient B
    117.3 ± 3.9
        Patient C
    120.1 ± 4.7
    No statistical analyses for this end point

    Other pre-specified: Diastolic blood pressure

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    End point title
    		 Diastolic blood pressure
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Baseline Visit (Day 1) to End of Study Visit (Week 20, 200 weeks and up to 208 weeks). Assessed at baseline, 4 weeks later and then at 8 weekly intervals up to 208 weeks after baseline.
    End point values
    		 Tapentadol Prolonged Release
    Number of subjects analysed
    3
    Units: mmHg
    arithmetic mean (standard deviation)
        Patient A
    71 ± 8.6
        Patient B
    66.4 ± 3.6
        Patient C
    66.5 ± 4.6
    No statistical analyses for this end point

    Other pre-specified: Heart Rate

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    End point title
    		 Heart Rate
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Baseline Visit (Day 1) to End of Study Visit (Week 20, 200 weeks and up to 208 weeks). Assessed at baseline, 4 weeks later and then at 8 weekly intervals up to 208 weeks after baseline.
    End point values
    		 Tapentadol Prolonged Release
    Number of subjects analysed
    3
    Units: beat(s) per minute
    arithmetic mean (standard deviation)
        Patient A
    81.3 ± 15.3
        Patient B
    65.3 ± 3.7
        Patient C
    63.6 ± 3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    up to 208 weeks after baseline visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Tapentadol Prolonged Release
    Reporting group description
    		 All patients maintained the same dose of tapentadol hydrochloride prolonged release (PR) with which they completed the preceding protocol, resulting from the dose titration and stabilization period. The tapentadol hydrochloride PR dose may have been adjusted under certain circumstances, and following an established procedure. All dosage adjustments must have been made at a patient visit to the study centre.

    Serious adverse events
    		 Tapentadol Prolonged Release
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Tapentadol Prolonged Release
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Epicondylitis
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Mar 2012
    There was one amendment to the original protocol (dated 21 Dec 2009). Apart from minor editorial corrections, the following changes were implemented by the amendment 01 (dated 9 Mar 2012): new address of the sponsor, updated study timelines, changes in the sponsor staff and improvement of the clarity and the consistency within the relevant protocol sections.

    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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    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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