Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.

    The EU Clinical Trials Register currently displays   38876   clinical trials with a EudraCT protocol, of which   6392   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools

    < Back to search results

    Print Download

    EudraCT Number:2010-019785-90
    Sponsor's Protocol Code Number:D2600C00012
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-07-09
    Trial results View results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2010-019785-90
    A.3Full title of the trial
    A Phase IIa, Double-blind, Randomised, Parallel-group, Multi-centre Study to Evaluate the Analgesic Efficacy of 28 Days Oral Administration of AZD2423 Compared to Placebo in Patients with Posttraumatic Neuralgia
    A.4.1Sponsor's protocol code numberD2600C00012
    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.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.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 nameAZD2423
    D.3.2Product code AZD2423
    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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 - 50
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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
    Posttraumatic Neuralgia (neuropathic pain)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    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
    To investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days of oral administration in patients with PTN.
    E.2.2Secondary objectives of the trial
    1. To investigate the responder rate of patients receiving AZD2423 compared to
    placebo in patients with PTN.
    2. To investigate the analgesic efficacy of AZD2423 on different components of pain
    compared to placebo in patients with PTN.
    3. To investigate the effect of AZD2423 on different functional consequences of pain
    compared to placebo in patients with PTN.
    4. To investigate the PK of AZD2423 in patients with PTN.
    5. To investigate the safety and tolerability of AZD2423 in patients with PTN.
    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 of non-child bearing potential (18-80 years, inclusive). Only
    women of non-child bearing potential are included in the study, ie, women who are
    permanently or surgically sterilised or post menopasual:
    − Women will be considered post menopausal if they are amenorrheic for 12
    months without an alternative medical cause.
    The following age-specific requirements apply:
    − Women under 50 years old will be considered post menopausal if they have
    been amenorrhoeic for 12 months or more following cessation of exogenous
    hormonal treatments and with LH and FSH levels in the post-menopausal
    − Women over 50 years of age will be considered postmenopausal if they have
    been amenorrheic for 12 months or more following cessation of all exogenous
    hormonal treatments.
    Permanent sterilization includes hysterectomy and/or bilateral oopherectomy and/or
    bilateral salpingectomy but excludes bilateral tubal occlusion.
    3. Neuropathic pain due to peripheral nerve injury caused by trauma or surgery.
    Duration of neuropathic pain must be at least three months and at most 5 years.
    Complex Regional Pain Syndrome (CRPS) type II is accepted provided that pain is
    due to a defined nerve injury. Nerve injuries at plexus or root level are excluded.
    4. Pain intensity (7 days recall) of 4-9 (inclusive) on NRS - Average Pain (0-10) is
    required for enrolment. At randomisation a 5-day mean baseline NRS - Average
    Pain intensity (12 h recall twice daily, morning and evening) of 4-9 (inclusive) is
    required. The patient is also required to complete at least 4 out of 5 morning and
    evening baseline NRS - Average Pain assessments Day –5 to Day –1 to be eligible.
    5. Be able to understand and comply with the requirements of the study as judged by the investigator.
    For inclusion in the genetic research, patients must fulfil the following criterion:
    6. Provision of informed consent for genetic research
    If a patient declines to participate in the genetic research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this CSP, so long as they consent.
    E.4Principal exclusion criteria
    1. Involvement in the planning and/or conduct of the study (applies to both
    AstraZeneca staff and/or staff at the study site).
    2. Previous enrolment or randomisation in the present study.
    3. Participation in another clinical study with an IP during the last 30 days prior to
    4. Other pain that may confound assessment of neuropathic pain, as judged by the
    5. Central neuropathic pain conditions (caused by CNS injury/disease, eg, stroke,
    multiple sclerosis or spinal cord injury).
    6. Any prior treatment of neuropathic pain with intrathecal pump or spinal cord
    7. History of treatment failure with ≥3 adequate trials of medications used to treat
    neuropathic pain, as judged by the investigator.
    8. Use of any prohibited medication (see Table 4) at Visit 2.
    9. History of any unstable medical disease (eg,, cardiovascular, renal insufficiency,
    hepatic insufficiency) which may interfere with the objectives of the study or with
    the safety of the subject, as judged by the investigator.
    10. History of gastric ulcer or haemorrhage
    11. History of significant psychiatric disease/disorder that could preclude reliable
    participation in the study, as judged by the investigator.
    − Patients with a diagnosis of depression who are in remission for at least 12 weeks before enrolment with or without stable SSRI treatment are allowed
    in the study.
    12. Patient with a cognitive disorder which could impair cooperation with study
    procedures, as judged by the investigator.
    13. Clinically significant illness within 2 weeks before the administration of the IP as
    judged by the investigator.
    14. Known malignancy within the past 5 years (with the exception of successfully
    treated basal cell carcinoma).
    15. Malabsorption, gastrointestinal disorder or surgery leading to impaired drug
    16. Donation of plasma from 2 weeks before Visit 1 (enrolment visit) or donation of
    blood from 3 months before Visit 1.
    17. Abnormal vital signs, laboratory test value or ECG of clinical significance, as
    judged by the investigator.
    − QTcF>450 ms or <340 ms, or a family history of long QT syndrome.
    − Calculated Creatinine clearance ≤50 mL/min assessed by the Cockroft-Gault
    − ALT or AST >1.5xULN
    − Bilirubin > 1xULN
    18. Positive Tuberculosis screening (i.e. chest x-ray and QuantiFERON® – TB Gold
    according to local requirements) as judged by investigator.
    19. Immunisation with live vaccine within the previous 3 months, for other vaccines
    within the past 30 days.
    20. History of latent, chronic, or recurrent infections (eg, tuberculosis, recurrent
    sinusitis, genital herpes, urinary tract infections) or at risk of infection (surgery,
    trauma or significant infection, history of skin abscesses within 90 days prior to
    Visit 1).
    21. Women with a positive pregnancy test on enrolment or before randomisation or
    lactating women.
    22. History of alcohol or drug abuse within 2 years of entering the study.
    23. Contraindication to ibuprofen/NSAIDs, such as ulcer and history of hypersensitivity
    reactions (eg, asthma, rhinitis or urticaria).
    24. History of or positive test of human immunodeficiency virus (HIV) or hepatitis B or
    25. Positive urine toxicology results for drugs of abuse including cannabis, cocaine,
    ecstacy, heroin/morphine, amphetamine and phenocyclidine (PCP). Visit 1 urine
    toxicology results indicating opiate or other prescribed analgesic (including
    benzodiazepines) use in patients who had been receiving the medications for
    therapeutic reasons are permitted. However, patients who test positive for opiates or other excluded medications at Visit 2 (after the appropriate washout) are excluded.
    In addition, any of the following is regarded as a criterion for exclusion from the genetic research:
    1. Previous allogeneic bone marrow transplant.
    2. Non-leukocyte depleted whole blood transfusion within 120 days of genetic sample collection.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in mean NRS Average Pain Score
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability and response rate
    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 No
    E. 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    The last visit of the last patient undergoing the study.
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 135
    F.4.2.2In the whole clinical trial 135
    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 Decision2010-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-30
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice