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    Summary
    EudraCT Number:2014-004535-40
    Sponsor's Protocol Code Number:0189/DEV
    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:2015-02-17
    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 number2014-004535-40
    A.3Full title of the trial
    Prospective, single-blind, placebo-controlled, three-treatment, three-period, adaptive multi-centre Phase IIa (proof-of-concept) trial to investigate the efficacy, safety, and tolerability of Ketamine HCl PR tablets in patients with chronic non-malignant neuropathic pain
    Prospektive, einfachblinde, placebokontrollierte, dreiphasige, adaptive multizentrische Phase-IIa-Studie (Proof-of-Concept) mit drei Behandlungen zur Untersuchung der Wirksamkeit, Sicherheit und Verträglichkeit von Ketamin-HCl-PR-Tabletten bei Patienten mit chronischen nicht-malignen neuropathischen Schmerzen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to investigate the efficacy, safety, and tolerability of Ketamine HCl PR tablets in patients with chronic non-malignant neuropathic pain
    A.4.1Sponsor's protocol code number0189/DEV
    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 SponsorDevelco Pharma Schweiz AG
    B.1.3.4CountrySwitzerland
    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 supportDevelco Pharma Schweiz AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDevelco Pharma Schweiz AG
    B.5.2Functional name of contact pointClinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressHohenrainstr. 12 D
    B.5.3.2Town/ cityPratteln
    B.5.3.3Post code4133
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41 61 4256558
    B.5.5Fax number+41 61 42550 29
    B.5.6E-maily.gschwind@develco.ch
    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 nameKetamine hydrochloride (HCl) prolonged-release (PR) tablets
    D.3.4Pharmaceutical form Prolonged-release 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 INNKetamine
    D.3.9.3Other descriptive nameKETAMINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02830MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.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 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 nameKetamine hydrochloride (HCl) prolonged-release (PR) tablets
    D.3.4Pharmaceutical form Prolonged-release 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 INNKetamine
    D.3.9.3Other descriptive nameKETAMINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02830MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.IMP: 3
    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 nameKetamine hydrochloride (HCl) prolonged-release (PR) tablets
    D.3.4Pharmaceutical form Prolonged-release 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 INNKetamine
    D.3.9.3Other descriptive nameKETAMINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02830MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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.IMP: 4
    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 nameKetamine hydrochloride (HCl) prolonged-release (PR) tablets
    D.3.4Pharmaceutical form Prolonged-release 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 INNKetamine
    D.3.9.3Other descriptive nameKETAMINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02830MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 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
    Chronic non-malignant neuropathic pain
    E.1.1.1Medical condition in easily understood language
    Pain caused by damage or disease affecting the sensory system
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10029223
    E.1.2Term Neuralgia
    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
    The primary objective of the trial is to investigate the effect of Ketamine HCl PR tablets administered twice daily as add-on therapy to the individual standard treatment regimen of each patient in comparison to placebo in the relief of chronic non-malignant neuropathic pain as determined by absolute changes in the “current” pain intensity (PI) score on the visual analogue scale (VAS).
    E.2.2Secondary objectives of the trial
    Secondary objectives are to investigate the effect of Ketamine HCl PR tablets administered twice daily as add-on therapy to the individual standard treatment regimen of each patient in comparison to placebo in improvement of symptoms of chronic non-malignant neuropathic pain as determined by relative changes in the “current” PI score on the VAS, as well as by absolute and relative changes in the Neuropathic Pain Symptom Inventory (NPSI), “recalled” average PI during the day and “recalled” average PI during the night.
    Moreover, a secondary objective is to assess the safety and tolerability of Ketamine HCl PR tablets administered twice daily as add-on therapy to the individual standard treatment regimen in patients with chronic non-malignant neuropathic pain.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female patients ≥18 years of age at Visit 1 (Screening)
    2. Patients with a documented history of chronic non-malignant neuropathic pain at Visit 1
    3. Patients with a DN4 Neuropathic Pain Diagnostic Questionnaire score of ≥4 at Visit 1
    4. Stable individual regular standard treatment regimen for chronic neuropathic pain, i.e. no change in drug and non-drug treatments for at least two weeks prior to Visit 1 and anticipated to remain stable until the end of the single-blind treatment phase. Use of rescue medication for neuropathic pain (including topical treatments, physical measures etc.) or any other co-medication used on an “as-needed” basis that might affect pain perception or pain intensity as well as opioids as part of the regular standard treatment are not allowed in this trial.
    5. Patients with inadequate pain control (mean “current” PI on VAS >50 mm) by their current individual standard treatment regimen on at least three days of the seven-day screening phase (to be checked at Visit 2)
    6. Patients willing and able (e.g. mental and physical condition) to participate in all aspects of the trial, including use of medication, completion of subjective evaluations, attending scheduled visits, completing telephone contacts, and compliance with protocol requirements as evidenced by providing signed written informed consent at Visit 1
    E.4Principal exclusion criteria
    1. Hypersensitivity or intolerance to ketamine or any of the excipients
    2. Patients treated with any other ketamine preparation within the last month prior to Visit 1
    3. Patients receiving opioids , regardless if as part of their individual standard treatment regimen for chronic neuropathic pain or in context with any other indication, within the last two weeks prior to Visit 1
    4. Patients with untreated or uncontrolled arterial hypertension (sitting systolic blood pressure at rest ≥160 mmHg and/or sitting diastolic blood pressure at rest ≥90 mmHg)
    5. History of cerebrovascular event (stroke, PRIND, TIA) within the previous six months prior to Visit 1
    6. Known or suspected cardiac disease, especially coronary artery disease (e.g. unstable angina, congestive heart failure), tachyarrhythmia and history of myocardial infarction
    7. Known or suspected hypovolemia or dehydration
    8. Known or suspected hyperthyroidism or patients receiving thyroid replacement therapy within the last two weeks prior to Visit 1
    9. Concomitant treatment with theophylline or aminophylline within the last two weeks prior to Visit 1
    10. Long-term therapy for any chronic disease, if suspected to be unstable during the course of the trial
    11. Regular or intermittent intake of St. John’s wort (hypericum perforatum), if not stopped at Visit 1
    12. Other non-drug treatments such as physical measures, acupuncture, etc., if not stable since at least two weeks prior to Visit 1 or suspected to be unstable during the course of the trial
    13. Known or suspected globe injury or increased intraocular pressure (e.g. glaucoma)
    14. Known or suspected cranio-cerebral trauma, intracranial mass lesions, hydrocephalus or elevation of intracranial pressure within the last three months prior to Visit 1 or sequelae of previous events
    15. Known or suspected convulsive disorder
    16. Known or suspected acute intermittent porphyria
    17. History or presence of moderate or severe psychiatric disorder (e.g. moderate or severe depression, schizophrenia or acute psychosis)
    18. Known or suspected current pulmonary or upper respiratory infection
    19. Known or suspected acute or chronic alcoholism, delirium tremens, or toxic psychosis
    20. History of any malignancy in the last five years; except history of in-situ cancer or basal or squamous cell skin cancer. Patients with other malignancies are eligible if they have been continuously disease free for at least five years
    21. Known or suspected CNS depression (signs/symptoms: decreased vital signs, impaired thinking and perception, slurred speech, slowed reflexes, fatigue, decreased consciousness)
    22. History of drug addiction or drug seeking behaviour, positive test of illicit drugs (other than medication used for individual standard treatment of pain) at Visit 1
    23. Surgery within one month, denervation procedures within six months or neural blockade (e.g. injection of a local anaesthetic into or near to a nerve), neuromodulatory measures (e.g. TENS) or radiotherapy two weeks prior to trial Visit 1 and/or anticipated and/or scheduled during the course of the trial
    24. Evidence of impaired hepatic function (total bilirubin, AST, ALT, GGT, or AP >3 times the upper limit of normal)
    25. Evidence of moderate or severe renal impairment (CRCL <60 ml/min) or patients with renal failure who are on any form of dialysis
    26. Any gastro-intestinal pathology or surgery or intractable vomiting likely to significantly influence drug absorption
    27. Inability to swallow the trial drugs whole (e.g. due to dysphagia).
    28. For women: Pregnancy or breast-feeding. Women of childbearing potential unable or unwilling to undergo pregnancy tests and practice adequate contraceptive measures. Reliable methods for women are hormonal contraceptives, surgical intervention (e.g. tubal ligation), intrauterine device (IUD), double-barrier methods and true sexual abstinence (i.e. when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. For men: Men unable or unwilling to practice adequate contraceptive measures. Reliable methods for men are surgical intervention (e.g. vasectomy), double-barrier methods or true sexual abstinence (i.e. when this is in line with the preferred and usual lifestyle of the patient).
    29. Any other condition of the patient that in the opinion of the investigator may compromise evaluation of the trial treatment or may jeopardize patient’s safety, compliance or adherence to protocol requirements
    30. Previous enrolment in the single-blind treatment phase of this trial or participation in any other clinical trial within the past 30 days prior to enrolment
    31. Persons committed to an institution by virtue of an order issued either by the judicial or other authorities
    E.5 End points
    E.5.1Primary end point(s)
    Primary end point is defined as the absolute change from baseline in “current” PI on 0 - 100 mm VAS (mean of all “current” PIs of the last four days of each treatment period) after Ketamine HCl PR Placebo tablets versus Ketamine HCl PR tablets.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary end point is evaluated at the end of the trial.
    E.5.2Secondary end point(s)
    • relative change from baseline in “current” PI on 0 – 100 mm VAS (mean of all “current” PIs of the last four days of each treatment period) after Ketamine HCl PR Placebo tablets versus Ketamine HCl PR tablets
    • absolute and relative change from baseline in NPSI total intensity score and NPSI sub-scores after Ketamine HCl PR Placebo tablets versus Ketamine HCl PR tablets
    • absolute and relative change from baseline in “recalled average PI during the day on 0 – 100 mm VAS (mean of all “recalled” PIs during day-time of the last four days of each treatment period) after Ketamine HCl PR Placebo tablets versus Ketamine HCl PR tablets
    • absolute and relative change from baseline in “recalled average PI during night on 0 – 100 mm VAS (mean of all “recalled” PIs during night-time of the last four days of each treatment period) after Ketamine HCl PR Placebo tablets versus Ketamine HCl PR tablets
    • adverse events (AEs)
    • vital signs, standard laboratory evaluations, electrocardiogram (ECG) and physical examinations
    • the rate of discontinuations due to AEs during the active treatment phase (defined as the time from the first ketamine intake in Period 2 until the last ketamine intake in Period 3).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary end points are evaluated at the end of the trial. In addition, an interim review based on safety and tolerability outcomes (mainly occurrence of AEs) will occur after stage 1, in order to determine dosing levels for stage 2 as outlined in the protocol.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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 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 No
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 trial1
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 No
    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
    LVLS
    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.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 70
    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)
    After the end of the trial, the patients will be treated according to local standard practice.
    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 Decision2015-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-06-22
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