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    Summary
    EudraCT Number:2006-001072-21
    Sponsor's Protocol Code Number:MKN106762
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-08-01
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-001072-21
    A.3Full title of the trial
    A double-blind placebo-controlled study of the efficacy and safety of the P38 Map Kinase inhibitor SB681323 in patients with neuropathic pain following nerve trauma
    A.4.1Sponsor's protocol code numberMKN106762
    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 and Development Ltd
    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 Information not present in EudraCT
    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 nameSB-681323
    D.3.2Product code SB-681323
    D.3.4Pharmaceutical form Film-coated 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 codeSB-681323
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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) No
    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 No
    D.3.11.3.2Gene therapy medical product No
    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 No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    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 No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    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 Information not present in EudraCT
    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 nameSB-681323
    D.3.2Product code SB-681323
    D.3.4Pharmaceutical form Film-coated 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 codeSB-681323
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) No
    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 No
    D.3.11.3.2Gene therapy medical product No
    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 No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    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 No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product No
    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 placeboFilm-coated tablet
    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
    MedDRA Classification
    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 effect of SB681323 on the clinical signs of neuropathic pain in patients with nerve trauma and/or compression
    E.2.2Secondary objectives of the trial
    •To investigate the effect of SB681323 on experimental psychophysical measures of sensitisation in pain pathways in patients with nerve trauma and/or compression
    •To investigate the effect of SB681323 on specific measures of the TRPV1 pathway in patients with nerve trauma and/or compression
    •To investigate the value of these additional exploratory endpoints for future studies in neuropathic pain patients
    •To assess the safety of SB681323 in patients with neuropathic pain
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects 18-80 years of age
    2. To be eligible, females patients must be of:
    a. non-childbearing potential (i.e. physiologically incapable of becoming pregnant).
    This includes any female who is post-menopausal. For the purposes of this study,
    post menopausal is defined as being amenorrhoeic for greater than 2 years with an
    appropriate clinical profile, e.g. age appropriate, history of vasomotor symptoms.
    Postmenopausal status will be confirmed by serum FSH and oestradiol
    concentrations at screening. Surgical sterility will be defined as females who have
    had a hysterectomy and/or bilateral oophorectomy or tubal ligation.
    OR
    b. childbearing potential and have a negative pregnancy test and agree to commit to
    one of the protocol-approved methods of contraception, when used consistently and
    in accordance with both the product label and the instructions of a physician, as
    indicated below:
    i. oral contraceptive (combined or progestin only), and the same oral contraceptive
    regimen has been used for at least two months prior to study drug administration, and the same method continues throughout the study and through the follow-up phase of the study.
    ii. progesterone implanted rods (e.g. Norplant ) inserted for at least two months prior to the study drug administration (but not beyond the third successive year following insertion) , and is continued throughout the study and through the follow-up phase of the study.
    iii. an IUD, inserted by a qualified clinician, with published data showing that the
    highest expected failure rate is less than 1% per year (not all IUDs meet this
    criterion) Acceptable IUDs: TCu-380A (Paragard), TCU-380 Slimline (Gyne T
    Slimline), TCu-220C, MULTILOAD-250 (MLCu-250), 375 and 375 SL, Nova T
    and Cunovat (Novagard), Levonorgesterol (LNG-20) Intra-uterine System
    (Mirena/Levonova), and FlexiGard 330/CuFix PP330 (Gynefix). The device must
    be inserted at least 2 weeks prior to the Screen visit, and remain throughout the study and through the follow-up phase of the study.
    iv. injectable medroxyprogesterone acetate (e.g., Depo-Provera) and is on a stable dose for 2 months prior to Screen, throughout the study and through the follow-up phase of the study.
    v. complete abstinence from intercourse from at least two weeks prior to Screen,
    throughout the treatment phase, and the follow-up phase.
    vi. double barrier method if comprised of a spermicide with either a condom or
    diaphragm from at least two weeks prior to Screen, throughout the treatment phase,
    and the follow-up phase.
    3. A diagnosis of peripheral neuropathic pain:
    • focal neuropathic pain related to nerve injury caused by trauma or surgery not
    associated with ongoing infection (examples include post-thoracotomy
    syndrome, post-mastectomy syndrome, post-inguinal herniorrhaphy syndrome,
    post-radical neck dissection syndrome, traumatic mononeuropathies- bullet
    wounds, lacerations, road traffic accidents)
    • pain associated with lumbo-sacral radiculopathy; patients with radiculopathy
    will only be included if they have pain radiating to or below the knee and have
    loss of small fibre function as indicated by quantitative sensory testing (warm
    sensation >9.6 0C or cool sensation >5.6 0C in L4, L5 or S1 dermatomes)
    [Quraishi, 2004]. The figures refer to change from the thermode baseline (see
    Section 6.8.4 for details).
    • carpal tunnel syndrome (CTS); patients with CTS will only be included if there
    is evidence of loss of large and/or small fibre function (confirmed by an
    electrophysiological nerve conduction examination or by quantitative sensory
    testing - warm sensation >5.2 0C or cool sensation >4.5 0C - in median nerve
    territory) (Anand et al, unpublished data). The figures refer to change from the
    thermode baseline (see Section 6.8.4 for details).
    • location of pain consistent with the area innervated by the affected nerve(s),
    with or without other sensory symptoms in the affected area
    • at least 3 months duration
    4. Baseline pain intensity score averaging 4 during the three days prior to
    randomisation as reported on the 11 point pain intensity numerical rating scale. For
    CTS patients, peak daily pain will be ≥4 for at least 3 days prior to randomisation.
    5. Subjects who have received nerve blocks or steroid injections for neuropathic pain
    may be included if their most recent nerve block was at least 4 weeks prior to
    randomisation.
    6. Body weight ≥50 kg (110 lbs) for men and ≥45 kg for women, Body Mass Index
    18.5-35kg/m2.
    7. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) within
    normal limits at screening.
    8. Subjects must have a QTc(b) of less than 450msecs for males and females or less
    than 480msecs for patients with bundle branch block at screening.
    9. The subject is able to understand and comply with protocol requirements,
    instructions & protocol-stated restrictions.
    10. Signed and dated written informed consent prior to admission to the study.
    E.4Principal exclusion criteria
    1. Any clinically significant medical history or abnormality found on physical
    examination, laboratory assessment or ECG at screening which, in the opinion of the
    investigator, could interfere with the interpretation of efficacy or safety data or which
    otherwise would contraindicate participation in a clinical study, in particular:
    • subjects with non-neuropathic pain component involvement, mononeuropathy
    multiplex, or more than one cause or potential cause for pain symptoms (e.g.
    trigeminal neuralgia, painful diabetic neuropathy, central post-stroke pain, phantom
    limb pain, peripheral neuropathy due to alcoholism, malignancy, HIV, syphilis, drug
    abuse, vitamin deficiency, hypothyroidism, liver disease, toxic exposure, or chronic
    neck pain);
    • subjects with intractable pain of unknown origin or active infection in the area of
    nerve injury/compression;
    • subjects who have had extensive soft tissue injury associated with extensive surgery
    in the treatment of their nerve injury. Any question regarding the definition of
    extensive surgery should be discussed with the GSK medical monitor;
    • history of Gilbert's syndrome or elevated bilirubin levels (total, direct or indirect) in
    a previous clinical study or at screening;
    • history of increased liver function tests (ALT, AST) above upper limit of normal in
    the past 6 months;
    • positive Hepatitis B surface antigen, positive Hepatitis C antibody or Hepatitis C
    nucleic acid result;
    • GI disorders that may interfere with safety assessments, e.g. diarrhoea.
    2. Recent start or change in dosing regimen (≤1 month prior to randomisation) of any medication which, in the opinion of the Investigator, may interfere with pain
    assessments or introduce a risk of drug-drug interactions (see Section 9.2, Prohibited
    Medications for details). Subjects may continue to take medications for the treatment
    of their neuropathic pain as long as the regimen is stable and does not contain
    prohibited medications.
    3. Unable to refrain from excessive use medications (e.g. sedatives) that in the opinion of Investigator may interfere with efficacy or safety assessments (benzodiazepines prescribed as hypnotic sleep agents allowed). Subject is unable to discontinue topical analgesics prior to randomization and for the duration of the study (see Section 9.2, Prohibited Medications for details).
    4. Subject is unable to refrain from nerve blocks during the study.
    5. Positive alcohol test or urine drug screen at screening. 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.
    6. History of regular alcohol consumption exceeding an average weekly intake of > 21 units (or an average daily intake of greater than 3 units) for males, or an average
    weekly intake of > 14 units (or an average daily intake of greater than 2 units) for
    females.
    7. Donation of blood in excess of 500 mL within a 30-day period prior to dosing.
    8. Participation in a trial with any drug within 3 months before the start of the study or
    participation in a trial with a new chemical entity within 4 months before the start of
    the study.
    9. Pregnant or nursing female subjects.
    10. Known history of hypersensitivity or intolerance to paracetamol products.
    11. Inability or unwillingness to follow the instruction of the study protocol.
    12. An unwillingness of male subjects to abstain from sexual intercourse with women; or unwillingness of the male subject to use a condom/spermicide in addition to having their female partner use another form of contraception (as described in inclusion criterion for women) if the woman could become pregnant from the time of the first dose of investigational product until completion of the follow-up procedures.
    E.5 End points
    E.5.1Primary end point(s)
    • Average daily pain score based on the 11 point pain intensity numeric rating scale, NRS (0=no pain, 10 maximum pain imaginable) over Week 1 and Week 2 of the treatment
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    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 Information not present in EudraCT
    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 2007-08-01. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state48
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 48
    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)
    Not applicable.
    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 Decision2006-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-08-11
    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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