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    Summary
    EudraCT Number:2004-004908-21
    Sponsor's Protocol Code Number:D0170C00006
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2005-01-25
    Trial 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 ConcernedDenmark - DHMA
    A.2EudraCT number2004-004908-21
    A.3Full title of the trial
    A Phase II, double-blind, randomized, cross-over, international,
    multicentre study to evaluate the analgesic efficacy of 3 weeks oral
    administration of AZD4282 300 mg b.i.d. compared with placebo in
    postherpetic neuralgia
    A.4.1Sponsor's protocol code numberD0170C00006
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 nameAZD4282 Tablet 50 mg
    D.3.2Product code AZD4282
    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.3.9.1CAS number 348630-12-6
    D.3.9.2Current sponsor codeAZD4282 Choline
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number63.30
    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 nameAZD4282 Tablet 200 mg
    D.3.2Product code AZD4282
    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.3.9.1CAS number 348630-12-6
    D.3.9.2Current sponsor codeAZD4282 Choline
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number253.20
    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.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
    Diagnosis of postherpetic neuralgia
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Information not present in EudraCT
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the analgesic efficacy of 3 weeks oral administration of AZD4282
    compared with placebo in postherpetic neuralgia.
    E.2.2Secondary objectives of the trial
    To explore the effects of AZD4282 compared with placebo on pain relief .
    •To explore the effects of AZD4282 compared with placebo on interference of pain
    with general activity, mood and sleep.
    •To explore the effects of AZD4282 compared with placebo on subjects/clinicians
    overall rating of treatment effect.
    •To explore the effects of AZD4282 compared with placebo on pain and global
    measures in terms of proportion of responders.
    •To explore the effects of AZD4282 compared with placebo on consumption of
    rescue medication.
    •To evaluate the safety and tolerability of AZD4282.
    •To evaluate pharmacokinetics/pharmacodynamics of AZD4282.
    . To generate a collection of DNA samples from subjects enrolled in the main study who provide, separate, optional consent.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Provision of informed consent.
    2. Be able to understand and comply with the requirements of the study.
    3. Female or male subjects 18-80 years of age.
    4. Female subjects must be post-menopausal by at least 2 years or surgically sterile.
    5. Diagnosis of postherpetic neuralgia, i.e. history of acute herpes zoster with pain
    persisting in the affected skin area at least 6 months after resolution of skin rash.
    6. Mean pain intensity ≥40 on 100 mm VAS during baseline week, based on
    recordings of average pain intensity last 24 hours.

    All inclusion criteria, except no 6, must be fulfilled at visit 1. All inclusion criteria must be
    fulfilled at visit 2.
    E.4Principal exclusion criteria
    1.Other pain that may confound assessment of pain attributed to postherpetic
    neuralgia, as judged by the investigator.
    2.Subjects that have been treated with neurolytic procedures (chemical or surgical
    nerve lesioning) for postherpetic neuralgia.
    3.Severe, unstable or insufficiently treated hypertension, cardiovascular,
    cerebrovascular or peripheral vascular disease, as judged by the investigator.
    4.Diabetes Mellitus requiring pharmacological treatment (insulin, antidiabetics), or,
    with any organ complication.
    5.Diagnosis or history of any severe neurological disease (e.g. epilepsy, MS,
    Parkinson´s disease, neurodegenerative disease), as judged by the investigator.
    6.History of alcohol or drug abuse within the last 2 years.
    7.Any other serious or unstable medical or psychiatric condition, as judged by the
    investigator (e.g. HIV, organ transplanted subjects, malignancy treatment).
    8.S-Creatinine above 106 µmol/L. Any AZ standard laboratory test value outside AZ
    extended reference range (S-Bilirubin, S-ASAT, S-ALAT, S-Alkaline Phosphatase,
    S-Creatinine, S-Albumin, S-Potassium, S-Calcium, S-Sodium, B-Hemoglobin, (B-Hb),
    B-Leucocyte Particle Concentration (B-LPC; including B-differential count:
    lymphocytes, monocytes, neutrophiles, eosinophiles, and basophiles, B-Platelet
    Particle count and dipstick test for U-Glucose, U-Protein, U-Hemoglobin (U-Hb),
    U-Leucocytes.
    9.Treatment with opioids (other than tramadol as rescue medication), cannabinoids,
    any antidepressants, anticonvulsants, or antiarrythmics from 3 weeks before visit 1
    (screening visit) until the last visit.
    10.Treatment with topical local anaesthetics, topical capsaicin, acupuncture, nerve
    blockade or nerve stimulation treatments.
    11.Treatment with acidic albumin bound drugs with a low safety margin, e.g. warfarin,
    cloxacillin, methotrexate, chloral hydrate, etacrynic acid.
    12.Treatment with potentially nephrotoxic drugs, e.g. acetylsalicylic acid exceeding
    160 mg daily dose, NSAIDs, COX-2-inhibitors, aminoglycosides, cefalosporins,
    sulfonamides, trimetoprim, lithium, cyclosporine.
    13.Treatment with substrates of CYP3A4 with a low safety margin, e.g.
    benzodiazepines, statines, calcium-channel blockers, sildenafil, macrolide
    antibiotics, ergot alkaloids, quinine, cisapride, astemizole, terfenadine, eplerenone.
    14.Treatment with NMDA-antagonists, e.g. ketamine, dextromethorphan, memantine.
    15.Treatment with probenecide.
    16.Treatment with herbal remedies that may interfere with the study interpretation, as judged by the investigator.
    17.Intake of energy drinks containing taurine or glucuronolactone.
    18.Donation of plasma from 2 weeks before visit 1 (screening visit), or donation of
    blood from 3 months before visit 1, and throughout the study.
    19.A history of symptoms of hypersensitivity reactions (such as asthma, rhinitis or
    urticaria) or contra-indications to paracetamol/acetaminophen or tramadol.
    20.Participation in another investigational drug study within 30 days prior to visit 1.
    21.Previous enrolment in the present study or any other study on AZD4282.
    All exclusion criteria, except no 8, must not be fulfilled at visit 1. None of the exclusion
    criteria must be fulfilled at visit 2.
    E.5 End points
    E.5.1Primary end point(s)
    The change in the mean value of all 24 hour average pain intensity
    recordings (every evening) from the baseline week to the last treatment
    week in each treatment period (eVAS).
    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 Yes
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 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 No
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 years
    E.8.9.1In the Member State concerned months2
    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 No
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 60
    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 Decision2005-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-02-28
    P. End of Trial
    P.End of Trial StatusOngoing
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