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    Summary
    EudraCT Number:2009-012836-33
    Sponsor's Protocol Code Number:KIP113049
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-09-29
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2009-012836-33
    A.3Full title of the trial
    A randomised, double blind study to evaluate the safety and efficacy of the p38 kinase inhibitor, GW856553, in subjects with neuropathic pain from lumbosacral radiculopathy
    A.4.1Sponsor's protocol code numberKIP113049
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Research & Development Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLosmapimod
    D.3.2Product code GW856553
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeGW856553
    D.3.9.3Other descriptive nameLosmapimod
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Neuropathic pain from lumbosacral radiculopathy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10037779
    E.1.2Term Radiculopathy
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effects of repeat oral dosing of GW856553 on neuropathic pain in
    subjects with lumbosacral radiculopathy.
    E.2.2Secondary objectives of the trial
    1. To investigate the effects of repeat oral dosing of GW856553 on low back pain in
    subjects with lumbosacral radiculopathy.

    2. To investigate the effects of repeat oral dosing of GW856553 on sleep, daily
    function and mood in subjects with pain from lumbosacral radiculopathy.

    3. To investigate the safety and tolerability of GW856553 in subjects with lumbosacral
    radiculopathy.

    4. To assess the pharmacokinetics of GW856553 (for patient compliance purposes
    only).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects aged 18 – 80 years inclusive, at the time of signing the
    informed consent.
    2. A female subject is eligible to participate if she is of:
    • Non-childbearing potential defined as pre-menopausal females with a documented
    tubal ligation or hysterectomy; or postmenopausal defined as 12 months of
    spontaneous amenorrheaview protocol for further information.
    • Child-bearing potential and agrees to use one of the contraception methods listed
    in Section 8.1 view protocol for further information.
    3. A diagnosis of neuropathic pain due to lumbosacral radiculopathy with the following
    characteristics1:
    • Pain perceived in one or both lower limbs at sites consistent with the area innervated by the L4, L5 or S1 nerve
    roots, with or without other sensory symptoms in the affected areas; (typically, the pain may be perceived in the
    buttock, thigh, calf, leg, foot or toes).
    • History of the pain suggestive that the cause of lumbosacral radiculopathy is due
    to injury of the lumbosacral nerve root(s) , view protocol for further information.
    • Duration of pain should be at least 12 weeks since onset.
    • Intensity of pain should be stable for the 2 weeks prior to Screening, based on
    clinical history.
    • As part of the neurological examination, the investigator must also conduct the
    procedures specified in the Standardised Evaluation of Pain and to calculate the total score. View protocol for
    further information.
    - Pain/sensory disturbance in dermatomal/myotomal distribution precipitated or
    exacerbated by straight leg raising (the straight leg raising test should be
    performed as specified in StEP;
    - Neurological examination of lower limbs shows impaired muscle power,
    sensory function or deep tendon reflexes in the territory of the affected nerve
    roots;
    - The total StEP score is ≥4 (indicative of lumbosacral radiculopathy as the
    cause of the pain);
    - Electromyographic (EMG) evidence of denervation in muscles innervated by
    the affected nerve roots;
    - Quantitative sensory tests (QST) showing evidence of altered sensory
    thresholds in dermatomes innerved by the affected nerve roots;
    At Screening, if the investigator is satisfied with the diagnosis based on clinical
    review, or if results from such investigations related to the current symptoms are
    already documented in the medical notes, then it is not essential for the
    investigator to conduct computerised tomography (CT)/magnetic resonance imaging (MRI), EMG or QST. View protocol for further information.
    However, all subjects who are considered eligible by the Investigator on clinical
    grounds but have not had an CT/MRI undertaken to support the diagnosis of LSR
    prior to Screening or where a previous CT/MRI scan is not available to the
    Investigator, are required to have an CT/MRI undertaken during the
    screening/baseline period (Day -28 to Day -1) view protocol for further information.
    4. Subjects on medications for neuropathic pain (view protocol) may only be included in the study if they have
    been on stable doses of such medications for at least 4 weeks prior to baseline period (Day -7).
    5. Subjects who have not received NSAIDs, COX-2 inhibitors and/or topical lidocaine
    for at least 5 half-lives or 2 weeks, whichever is longer prior to the baseline period
    (Day -7), and for subjects who have not received topical capsaicin for at least 8
    weeks prior to the baseline period.
    6. Subjects who have not received nerve blocks and/or steroid injections for neuropathic pain for at least 4 weeks
    prior to the baseline period (Day -7).
    7. Subjects’ baseline average daily pain score for neuropathic pain due to LSR on the
    PI-NRS, calculated as the average of their daily PI-NRS scores over the baseline
    period (Day -7 to Day -1), is greater than or equal to 4 on the PI-NRS, after wash-out
    of prohibited medications view protocol.
    8. Male subjects must agree to use the contraception methods listed in Section 8.1.
    This criterion must be followed from the time of the first dose of study medication
    until 14 days after the last dose of study medication.
    9. Body weight ≥ 50 kg for men and ≥ 45 kg for women.
    10. Subject has provided full written informed consent prior to the performance of any protocol-specified
    procedure, which includes compliance with the requirements and restrictions listed in the consent form.
    11. Single QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle
    Branch Block. If the first QTc exceeds the above limits, repeat the ECG twice at
    least 5 min apart and take the mean of the three QTc values to determine that the
    mean QTc satisfies the above limits.
    12. A subject with a clinical abnormality or other laboratory parameters outside the
    reference range for the population being studied may be included view protocol for further information.
    E.4Principal exclusion criteria
    1. Subjects who, in the opinion of the Investigator, are unable to reliably delineate or
    assess their own pain by anatomical location/distribution (e.g. can the subject
    reliably tell the difference between their back pain and their lower limb pain and rate
    their intensity separately ?).
    2. Subjects with lumbar canal stenosis in which the pain in the lower limbs occur solely on walking and not at
    rest.
    3. Subjects with causes for their neuropathic pain other than that specified in Inclusion Criterion 3 view protocol,
    pain associated with a substantial somatic pain component [e.g.non-neuropathic /musculoskeletal pain in
    lower limbs or other parts of the body apart from the back] or more than one cause or potential cause for pain symptoms or any concurrent rheumatic disease such as but not limited to fibromyalgia, rheumatoid arthritis or
    significant osteoarthritis. Any question regarding the acceptability of aetiology of the neuropathic pain should be
    discussed with the GSK medical monitor.
    4. A positive pre-study drug/alcohol screen. However, a positive drug screen will not
    automatically exclude a subject if there is a medical explanation for the positive
    result other than drug abuse e.g. a subject who is taking opioids for their neuropathic pain.
    5. A positive test for HIV antibody or positive history of HIV.
    6. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
    result within 3 months of screening
    7. History of any liver disease within the last 6 months [with the exception of known
    Gilbert’s disease].
    8. History of excessive regular alcohol consumption within 6 months of the study
    defined as outlined in protocol.
    9. History or presence of significant cardiovascular, gastro-intestinal, or renal disease
    or other condition known to interfere with the absorption, distribution, metabolism,
    or excretion of drugs which, in the opinion of the Investigator may interfere with the
    study procedures or compromise subject safety.
    10. History or presence of any clinically significant abnormality in vital signs / ECG /
    laboratory tests, or have any medical or psychiatric condition, which, in the opinion
    of the Investigator, may interfere with the study procedures or compromise subject
    safety.
    11. Subject has clinical evidence of recent major depression (by medical history) except those subjects already
    controlled by anti-depressants at screening.
    12. Subjects who, in the clinical judgement of the investigator, may be malingering or be motivated by secondary
    gain from participation in the study will be excluded. View protocol for further information.
    13. Changes to medications permitted for the treatment of neuropathic pain (Section 9.1) within 4 weeks of the
    baseline period (Day -7), including dose adjustment,
    withdrawal of medications or initiation of new medications.
    14. Subjects who are unable to maintain the same medications for the treatment of
    neuropathic pain at the same stable dose as at baseline during the study.
    15. Unable to refrain from excessive use of sedative medications (e.g. benzodiazepines
    prescribed as hypnotics) that in the opinion of the Investigator may interfere with
    efficacy or safety assessments.
    16. Use of other prescription or non-prescription drugs, within 7 days (or 14 days if the drug is a potential enzyme
    inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication (Day 1) or during the
    study, view protocol for further information.
    17. Unable to stop and remain abstained from non-pharmacological treatments for their neuropathic pain during
    the study as specified in Section 9.3.
    18. The subject has participated in a clinical trial and has received an investigational
    product within the following time period prior to the baseline period (Day -7) in the
    current study: 5 half-lives or twice the duration of the biological effect of the
    investigational product (whichever is longer).
    19. Exposure to more than four new chemical entities within 12 months prior to the first dosing day (Day 1).
    20. History of hypersensitivity to GW856553 or its components thereof or a history of
    drug or other allergy that, in the opinion of the investigator or GSK Medical
    Monitor, contraindicates their participation.
    21. Where participation in the study would result in donation of blood or blood products in excess of 500 mL
    within a 56 day period.
    22. Pregnant females as determined by positive urine or serum hCG test at screening or prior to dosing.
    23. Lactating females.
    24. Unwillingness or inability to follow the procedures outlined in the protocol.
    25. Subject is mentally or legally incapacitated.
    26. Subjects with conditions requiring immunosuppressive therapy, or otherwise
    considered immunosuppressed.
    E.5 End points
    E.5.1Primary end point(s)
    Change in average daily neuropathic pain score from baseline to Week 5 of treatment based on the 11 point Pain
    Intensity Numerical Rating Scale (PI-NRS) (0=no pain, 10=maximum pain imaginable).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Group Study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last subject last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-09-29. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 142
    F.4.2.2In the whole clinical trial 142
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Subjects will not receive any additional treatment after completion of this phase 2 study. They will continue or change any prior medications which were given as standard care for the treatment of lumbosacral radiculopathy, or may start medications/other treatments as directed by the clinician who normally cares for them.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-08-23
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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