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    Summary
    EudraCT Number:2008-004933-99
    Sponsor's Protocol Code Number:PXN110527
    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:2008-09-09
    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 number2008-004933-99
    A.3Full title of the trial
    Study PXN110527: The investigation of the efficacy and pharmacokinetics of XP13512 in subjects with neuropathic pain associated with post-herpetic neuralgia (PHN) who have had an inadequate response to gabapentin treatment.
    A.4.1Sponsor's protocol code numberPXN110527
    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 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.3.2Product code GSK1838262
    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 codeGSK1838262
    D.3.9.3Other descriptive nameXP13512
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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 No
    D.3.11.8Extractive medicinal product No
    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.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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10054095
    E.1.2Term Neuropathic pain
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to investigate the difference between two doses of XP13512 (3600 mg/day vs. 1200 mg/day) on pain intensity.
    E.2.2Secondary objectives of the trial
    • To investigate the difference between two doses of XP13512 (3600 mg/day vs.
    1200 mg/day) on secondary outcomes including pain-related measures, percentage of subjects achieving various levels of pain reduction, physical functioning and global
    functioning.
    • To investigate the safety of XP13512.
    • To estimate the systemic exposure of gabapentin following 1200 mg/day and
    3600 mg/day XP13512 in subjects with inadequate response to 1800 mg/day
    gabapentin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Outpatient subjects aged 18 years or older, with a documented medical diagnosis of PHN of ≥3 months in duration prior to screening (i.e. pain present for at least 3
    months from the healing of a herpes zoster skin rash).
    2. A female subject is eligible to enter and participate in the study if she:
    • Is of non-childbearing potential (refer to Section 11.3).
    or
    • Is of child-bearing potential (refer to Section 11.3), is not lactating and has a
    negative pregnancy test ≤7 days prior to study treatment initiation and agrees to
    use one of the GSK specified highly effective methods for avoiding pregnancy
    (refer to Section 11.4).
    3. For the purposes of this study, PHN is defined as pain persisting for ≥3 months after healing of the shingles rash.
    Subjects with the above definition of PHN must satisfy the following criteria to be
    eligible for the study:
    • Subjects currently on a stable dose of 1800 mg/day of gabapentin1 for 2 weeks
    or more since the diagnosis of PHN, with inadequate response2;
    • Subjects not currently treated with gabapentin but previously treated with
    ≥1800 mg/day of gabapentin for 4 weeks or more since the diagnosis of PHN
    with inadequate response2.
    1 May previously have been on >1800 mg/day of gabapentin since diagnosis of PHN.
    2 Inadequate response will be based on investigator judgement - i.e., some reduction in pain intensity observed but not clinically meaningful for the patient.
    In either of the above scenarios subjects may have also been previously treated with
    pregabalin monotherapy (at a dose of 150-300 mg/day) for at least 4 weeks since the diagnosis of PHN with inadequate response2.
    Subjects showing no response3 to previous treatment with either gabapentin
    (≥1800 mg/day) or pregabalin (150-300 mg/day) taken for at least 4 weeks since the diagnosis of PHN are not eligible for the trial.
    3 No response will be based on investigator judgement - i.e., no reduction in pain
    intensity observed.
    4. The baseline 24-hour average pain intensity score is ≥4.0 based on an 11-point
    PI-NRS. The baseline score is the calculated mean of the daily scores (based on at
    least 4 assessments) taken during the 7 days prior to randomization. Subjects are to
    continue to take gabapentin 1800 mg/day provided by GSK during the Baseline
    Period.
    5. Subject is compliant with the gabapentin treatment supplied during the 14-day
    Baseline Period. Compliant is defined as administering ≥80% of the total supplied
    treatment over the 14-day Baseline Period.
    6. Subject is able to provide written informed consent prior to participation in the study. The contents and process of obtaining informed consent will be in accordance with all applicable regulatory requirements.
    E.4Principal exclusion criteria
    1. Has other chronic pain conditions not associated with PHN. However, the subject
    will not be excluded if ALL the following criteria apply:
    • The pain is located at a different region of the body.
    • The pain intensity is not greater than the pain intensity of the PHN ; and
    • The subject can assess PHN pain independently of the other pain condition.
    2. Is unable to discontinue:
    • Prohibited medications, or
    • Non-drug therapies or procedures (i.e. nerve blocks, trans-cutaneous electrical
    nerve stimulation [TENS]) for the relief of pain of PHN
    for the required washout period and throughout the duration of the study (refer to
    Section 5.6.2).
    3. Has any of the following medical conditions, laboratory abnormalities or disorders:
    • Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate
    aminotransferase (AST) > 2x upper limit of normal (ULN) or alkaline phosphatase
    or bilirubin > 1.5x ULN.
    • Chronic hepatitis B or C with a positive Hepatitis B surface antigen (HBsAg) or
    Hepatitis C Core Antigen Antibody (Hep C antibody). If Hepatitis C antibody test is positive, then the validity of the result should be confirmed by a RIBA before excluding the subject.
    • Impaired renal function defined as either creatinine clearance < 60 mL/min
    (estimation of creatinine clearance by Cockroft and Gault Method) or renal
    dysfunction requiring hemodialysis.
    • Corrected QT (QTc) interval ≥450 msec (based on single or average QTc value of
    triplicate electrocardiograms (ECGs) obtained over a brief recording period).
    • QTc interval ≥ 480 msec for patients with Bundle Branch Block.
    • Uncontrolled hypertension at screen (sitting systolic blood pressure [SBP]
    >160 mmHg and/or sitting diastolic blood pressure [DBP] >90 mmHg.
    • Current diagnosis of active epilepsy or any active seizure disorder requiring chronic
    therapy with antiepileptic drug(s).
    • Medical condition or disorder that would interfere with the action, absorption,
    distribution, metabolism, or excretion of XP13512, or, in the investigator’s
    judgement:
    • Is considered to be clinically significant and could pose a safety concern or,
    • Could interfere with the accurate assessment of safety or efficacy or,
    • Could potentially affect a subject’s safety or study outcome.
    Examples of such medical conditions include:
    • Skin conditions at the site of the neuropathy.
    • Active infection at the site of the neuropathy.
    • Current or chronic history of liver disease (including acute viral hepatitis), or
    known hepatic or biliary abnormalities (with the exception of Gilbert’s
    syndrome or asymptomatic gallstones).
    4. Meets criteria as defined by the Diagnostic and Statistical Manual of Mental
    Disorders (DSM-IV-TR) for a major depressive episode or for active significant
    psychiatric disorders within last year, including dementia, general anxiety disorder,
    psychosis or bipolar disorder.
    • Subjects with a history of depression that is in remission, with or without
    antidepressant treatment, may participate, unless a stable antidepressant regimen
    includes a prohibited medication.
    • Antidepressant medication may not be changed or discontinued to meet entry
    criteria and must be stable for at least three months prior to the start of the
    Baseline Period.
    5. Has a history of clinically significant drug or alcohol abuse as defined by
    DSM-IV-TR or is unable to refrain from substance abuse throughout the study.
    Benzodiazepines or atypical benzodiazepines prescribed as hypnotic sleep agents are permitted.
    6. Is currently participating in another clinical study in which the subject is, or will be
    exposed to an investigational or non-investigational drug or device.
    7. Has participated in a clinical study in which the subject was exposed to an
    investigational or non-investigational drug or device:
    • Within the preceding month for studies unrelated to the current illness, or
    • Within the preceding six months for studies related to the current illness.
    8. Has been treated previously with XP13512.
    9. Has a history of an allergic reaction, or a medically significant adverse reaction to
    any of the following:
    • The investigational products (including gabapentin) or,
    • Their excipients or,
    • Acetaminophen or paracetamol or,
    • Compounds closely related to acetaminophen or paracetamol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the mean 24-hour average pain intensity score for the last week of treatment of each treatment period based on an 11-point PI-NRS.
    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 Yes
    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 No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    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 concerned11
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months11
    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 No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 98
    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 the study
    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 Decision2008-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-07-27
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