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    Clinical Trial Results:
    A Multicenter, Randomized, Double-blind, Placebo- and Active-Controlled Study Comparing the Safety and Analgesic Efficacy of ABT-110 to Placebo in Subjects with Chronic Low Back Pain

    Summary
    EudraCT number
    2011-002143-95
    Trial protocol
    NO   PL   IT   FI  
    Global end of trial date
    19 Dec 2012

    Results information
    Results version number
    v1(current)
    This version publication date
    20 Apr 2016
    First version publication date
    09 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M12-141
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6 4XE
    Public contact
    Global Medical Information, AbbVie, 001 800-633-9110,
    Scientific contact
    Jerry Hall, MD, AbbVie, jerry.hall@abbvie.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
    19 Dec 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Dec 2012
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective for this study is to compare the safety, tolerability and the analgesic efficacy of ABT-110 administered subcutaneously (SC) once every 8 weeks (q8w) for a total of two doses to placebo in subjects with chronic low back pain (CLBP). One subject was enrolled into the study prior to the study being prematurely discontinued by the Sponsor based on a strategic business decision. No statistical, pharmacokinetic or pharmacogenetic analyses were performed. Safety data are provided for the 1 subject who received placebo.
    Protection of trial subjects
    Subject and/or legal guardian read and understood the information provided about the study and gave written permission.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    13 Nov 2012
    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
    South Africa: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    0
    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)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Approximately 330 subjects were planned to be enrolled. One subject was enrolled into the study prior to the study being prematurely discontinued by the Sponsor based on a strategic business decision.

    Pre-assignment
    Screening details
    One subject was enrolled and randomized to receive placebo. No subjects were randomized to ABT-110 (planned doses of 5, 10, 20, and 30 mg ABT-110) or naproxen (planned dose of 500 mg).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Arm title
    Placebo
    Arm description
    Placebo for ABT-110 by subcutaneous (SC) injection every 8 weeks (q8w) for a total of 2 doses, and placebo for naproxen by capsule orally once daily (BID) for 16 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo for ABT-110
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo for ABT-110 administered by subcutaneous injection

    Investigational medicinal product name
    Placebo for naproxen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo for naproxen administered orally as capsule

    Number of subjects in period 1
    Placebo
    Started
    1
    Completed
    0
    Not completed
    1
         Early termination of study by Sponsor
    1

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo for ABT-110 by subcutaneous (SC) injection every 8 weeks (q8w) for a total of 2 doses, and placebo for naproxen by capsule orally once daily (BID) for 16 weeks.

    Primary: Change from Baseline to Week 16 in Subject's Assessment of Chronic Lower Back Pain (CLPB) Intensity by 100 mm Visual Analog Scale (VAS)

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    End point title
    Change from Baseline to Week 16 in Subject's Assessment of Chronic Lower Back Pain (CLPB) Intensity by 100 mm Visual Analog Scale (VAS) [1]
    End point description
    The change from the baseline visit to Week 16 in subject's assessment of pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable).
    End point type
    Primary
    End point timeframe
    Baseline Visit (prior to dosing on day of initial study drug administration) to Week 16
    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: Not analyzed due to study termination
    End point values
    Placebo
    Number of subjects analysed
    0 [2]
    Units: mean
        arithmetic mean (standard deviation)
    ±
    Notes
    [2] - not analyzed due to study termination
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events were collected from the time of study drug administration through follow up at Week 20 (20 weeks); serious adverse events were collected from the time that informed consent was obtained (24 weeks).
    Adverse event reporting additional description
    All adverse events were collected whether solicited or spontaneously reported by the subject.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo for ABT-110 by subcutaneous (SC) injection every 8 weeks (q8w) for a total of 2 doses, and placebo for naproxen by capsule orally once daily (BID).

    Serious adverse events
    Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (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
    Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The study was terminated. No adverse events were reported for the 1 subject enrolled.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Apr 2012
    To change the low end of the tested dose range from 3 mg to 5 mg ABT-110 and to decrease the upper dose limit from 40 mg to 30 mg ABT-110; add additional post study drug administration monitoring; update safety and pharmacokinetic information because data was no longer preliminary; add description of study's anticipated benefits and risks; decrease the sample size from 390 (65 per arm) to 330 (55 per arm); revise inclusion and exclusion criteria to clarify criterion for duration of history of chronic low back pain and therapeutic dosing, add upper limit for BMI, increase threshold score for Mini-Mental Status Examination score, and exclude subjects with clinically significant allergy to medications used in study, history of rapidly progressive osteoarthritis, scoliosis surgery, osteoarthritis, or juvenile rheumatoid arthritis, or coronary artery bypass graft; provide additional detail regarding exclusionary treatment with corticosteroids, prohibited medications, or prior biologic therapy; clarify study procedures; clarify timing of efficacy measures; clarify role of the independent data monitoring committee; update adverse event definitions and management; and add interim efficacy and pharmacokinetic analyses.

    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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