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    Summary
    EudraCT Number:2010-019785-90
    Sponsor's Protocol Code Number:D2600C00012
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-07-15
    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 ConcernedSweden - MPA
    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.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with posttraumatic neuralgia
    A.4.1Sponsor's protocol code numberD2600C00012
    A.7Trial is part of a Paediatric Investigation Plan No
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ cityN/A
    B.5.3.3Post codeN/A
    B.5.3.4CountrySweden
    B.5.6E-mailinformation.center@astrazeneca.com
    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 No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINN not yet assigned
    D.3.9.2Current sponsor codeAZD2423
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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)
    E.1.1.1Medical condition in easily understood language
    Posttraumatic neuropathic pain
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10054095
    E.1.2Term Neuropathic pain
    E.1.2System Organ Class 10029205 - Nervous system disorders
    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 non-pregnant and non-lactating female (18-80 years, inclusive). Women considered to be of non-child bearing potential included in the study must be permanently or surgically sterilised or post menopausal:
    -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 range.
    -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.
    Women of childbearing potential included in the study must use a contraceptive method capable of achieving a failure rate of less than 1 percent per year when used consistently and correctly such as: cupper IUD, intrauterine levonorgestrel system, medroxyprogesterone depot injections, etonogestrel implants or normal and low dose combination pills. Not acceptable methods includes, but is not restricted to: barrier methods, progesterone pills, non-cupper IUD and coitus interruptus.
    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 enrolment.
    4. Other pain that may confound assessment of neuropathic pain, as judged by the
    investigator.
    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 stimulator.
    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 absorption.
    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 method.
    − 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 C.
    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.5.1.1Timepoint(s) of evaluation of this end point
    Baseline (Day –5 to Day –1) to Day 24 to Day 28.
    E.5.2Secondary end point(s)
    1. Change from baseline in Numeric Rating Scale Pain Interference on Sleep and Activity score
    2. To investigate the safety and tolerability of AZD2423
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Baseline (Day –5 to Day –1) to Day 24 to Day 28.
    2. Weekly
    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.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.8.2.4Number of treatment arms in the trial3
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Russian Federation
    E.8.7Trial has a data monitoring committee Yes
    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 months18
    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 months18
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 62
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 63
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 115
    F.4.2.2In the whole clinical trial 135
    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)
    No plans for treatment or care after the subjects has ended his/her participation in the trial will occur, unless medically indicated. In such case subjects will be referred to appropriate health care.
    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 Decision2011-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-04-03
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