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    Summary
    EudraCT Number:2009-012094-35
    Sponsor's Protocol Code Number:D5090C00018
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-07-14
    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 number2009-012094-35
    A.3Full title of the trial
    A Phase IIa randomised, double-blind, placebo controlled, parallel group, multicentre study evaluating the efficacy, safety, tolerability and pharmacokinetics of AZD1386 after 3 weeks of treatment in patients with Posttraumatic Neuralgia (PTN) and Postherpetic Neuralgia (PHN)
    A.4.1Sponsor's protocol code numberD5090C00018
    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 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 nameAZD1386
    D.3.2Product code AZD1386 30 mg
    D.3.4Pharmaceutical form Capsule, hard
    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 codeAZD1386 hydrogen sulphate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 placeboCapsule, hard
    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
    Patients with Posttraumatic Neuralgia (PTN) and Postherpetic Neuralgia (PHN)

    Intended Indication is 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 10029223
    E.1.2Term Neuralgia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to evaluate the analgesic efficacy of 21 days of oral administration of AZD1386 compared to placebo in patients with Post Traumatic Neuralgia (PTN) or Post Herpetic Neuralgia (PHN) with mechanical hypersensitivity
    E.2.2Secondary objectives of the trial
    1. To evaluate the response rate of patients to AZD1386 versus placebo.
    2. To evaluate the effect of AZD1386 on different components of pain compared to placebo.
    3. To evaluate the effect of AZD1386 on different descriptors of pain compared to placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Provision of informed consent prior to any study specific procedures

    2.Male or female patients ≥18 and <80 years of age. Females must not be of childbearing potential or must have a highly effective contraceptive method for the last 3 months, as described in Appendix D.
    Women not being of childbearing potential are defined as women who are permanently or surgically sterilized or postmenopausal. Permanent sterilisation includes hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy but excludes bilateral tubal occlusion. Postmenopausal women are defined as over 50 years old and have been amenorrheic for 12 months or more, following cessation of all exogenous hormonal treatments, or over 57 years old.

    3.Patients with painful symptoms due to neuropathic pain for a period of three months to five years. At examination patients have to have mechanical hypersensitivity (allodynia and/or punctate hyperalgesia).
    Definition of allodynia: A painful sensation to a non-painful stimulus.
    Definition of hyperalgesia: An exaggerated painful sensation to a painful stimulus.
    Patients will be eligible for inclusion if all criteria for one of the following disease-specific criteria are met:
    - PTN: Pain directly related to peripheral nerve injury caused by trauma or surgery and not associated with ongoing infection. Examples include but are not limited to post-inguinal herniorrhaphy syndrome, post-thoracotomy syndrome, and traumatic mononeuropathies.
    - PHN: A history of Herpes Zoster (Shingles) with pain persisting in the affected skin area at least three months after resolution of the skin rash.

    4.A pain intensity (7 days recall) of ≥4 to ≤9 on NRS (0-10) is required for enrolment.
    At randomisation (Visit 3) a 4-day mean baseline pain intensity (12 h recall twice daily, morning and evening) of ≥4 to ≤9 is required. The patient is also required to complete at least 3 out of 4 morning and evening baseline NRS assessments (evening of Day – 4 until morning of Day 1) to be eligible.

    5.Patients must be both willing and able to comply with and understand the study requirements.
    E.4Principal exclusion criteria
    1. Other pain conditions that may confound assessment of neuropathic pain, as judged by the investigator
    2. Central neuropathic pain conditions such as associated with stroke, multiple sclerosis, or spinal cord injury
    3. Any prior treatment of neuropathic pain with neurolytic therapy, intrathecal pump, spinal cord stimulator or neurosurgery
    4. History, and/or presence, of somatic disease/condition, which may interfere with the objectives of the study as judged by the investigator
    5. Diagnosis of any severe neurological disease (e.g. epilepsy, MS, Parkinson´s disease, neurodegenerative disease) as judged by the investigator
    6. Malabsorption, gastrointestinal disorder or surgery leading to impaired drug absorption
    7. History of malignancy, treated or untreated, within the past 5 years, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin
    8. Risk factors for ventricular fibrillation (e.g. family history of Short QT syndrome (SQTS) or sudden cardiac death (SCD) amongst first-degree relatives
    9. QTcF interval <350 msec or >450 msec at enrolment
    10. A recent history (in the past 3 months) suggestive of alcohol or drug abuse or dependence, including overuse/abuse of narcotics for management of pain
    11. Enrolment laboratory value for ALT, AST >2 times the upper limit of normal range
    12. Positive test result for hepatitis B surfactant antigen (HbsAg) or hepatitis C antibody
    13. Known or suspected human immunodeficiency virus (HIV) infection, as judged by the investigator
    14. Clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
    15. Use of any prohibited medication at V2
    16. History of treatment failure with ≥ 3 adequate trials of medication used to treat neuropathic pain. Failure could be insufficient efficacy or discontinuation due to side effects.
    17. History of significant psychiatric disease/disorder that could preclude reliable participation in the study in the judgement of the investigator. Subjects with a diagnosis of depression who are in remission for at least 12 weeks before enrolment with or without stable selective serotonin reuptake inhibitor (SSRI) treatment are allowed in the study.
    18. Patients involved in processes regarding monetary compensation due to the condition under study (e.g. insurance issues).
    19. Breast-feeding women
    20. Positive pregnancy test
    21. Donation of plasma within the two weeks prior to the enrolment visit and/or donation of blood within the three months prior to the enrolment visit and during the study
    22. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
    23. Participation in other clinical trial, use of any investigational drugs or procedures or use of experimental medications within 30 days prior to the enrolment visit
    24. According to the investigator the patient should not participate in the study
    25. Clinically significant illness within two weeks before the administration of the investigational product, as judged by the investigator
    26. Patients with a cognitive disorder which would impair cooperation with study procedures, as judged by the investigator
    27. Previous randomisation in the present study
    28. A history of symptoms of hypersensitivity reactions (such as asthma, rhinitis or urticaria) or contraindications to paracetamol/acetaminophen
    29. Positive urine drugs of abuse screen including cannabis, cocaine, heroin/morphine, amphetamine and PCP
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in NRS pain (12 h-recall), morning and evening measurement
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    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 Yes
    E.8.1.6Cross over No
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 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 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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 90
    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 Decision2009-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-12-18
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