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   41228   clinical trials with a EudraCT protocol, of which   6756   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    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

    Summary
    EudraCT Number:2015-000538-31
    Sponsor's Protocol Code Number:Neuroimpa2015
    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:2015-04-07
    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 ConcernedGermany - BfArM
    A.2EudraCT number2015-000538-31
    A.3Full title of the trial
    NEUORIMPA - Intraarticular Application of Opioids in Chronic Arthritis of the knee joint
    NEUORIMPA - Intraartikuläre Applikation von Opioiden bei chronischer Arthritis des Kniegelenks
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Application into the joint of opioids in chronic arthritis of the knee joint
    Injektion von Morphin ins Kniegelenk bei Kniegelenksarthritis
    A.3.2Name or abbreviated title of the trial where available
    Neuroimpa - knee joint
    Neuroimpa- Kniegelenk
    A.4.1Sponsor's protocol code numberNeuroimpa2015
    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 SponsorCharité University medicine Berlin
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBundesministerium für Bildung und Forschung
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité Campus Benjamin Franklin Department of Rheumatology
    B.5.2Functional name of contact pointTrial Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressHindenburgdamm 30
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code12203
    B.5.3.4CountryGermany
    B.5.4Telephone number+493084454414
    B.5.5Fax number+493084454149
    B.5.6E-mailhildrun.haibel@charite.de
    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 Yes
    D.2.1.1.1Trade name Morphine Hexal
    D.2.1.1.2Name of the Marketing Authorisation holderHexal
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMorphinsulfat
    D.3.9.3Other descriptive nameMORPHINE SULFATE
    D.3.9.4EV Substance CodeSUB14597MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 RoleComparator
    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 Yes
    D.2.1.1.1Trade name Triam 40 mg Lichtenstein
    D.2.1.1.2Name of the Marketing Authorisation holderLichtenstein
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRIAMCINOLONACETONID
    D.3.9.3Other descriptive nameTRIAMCINOLONACETONID EP
    D.3.9.4EV Substance CodeSUB41525
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboIntraarticular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    chronic arthritis of the knee joint effusion as part of spondyloarthritis (Assessments in SpondyloArthritis international Society, ASAS criteria), Rheumatoid Arthritis, RA (according to American Col-lege of Rheumatology, ACR criteria), undifferentiated mono- or oligoarthritis, Osteoarthritis of the knee, OA.
    Kniegelenksarthritis im Rahmen einer Spondyloarthritis (ASAS Kriterien), Rheumatoid Arthritis (ACR Kriterien) unidfferenzierten Mono- oder Oligoarthritis, Gonarthrose
    E.1.1.1Medical condition in easily understood language
    Gonarthritis as part of spodyloarthritis, rheumatoid arthritis, undifferentiated arthritis of one or more than one joints, osteoarthritis
    Kniegelenkentzündung im Rahmen einer Spondyloarthrits, rheumatoiden Arthritis, undifferenzierten Arthris eines oder mehrerer Gelenke, Kniegelenksarthrose
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10067624
    E.1.2Term Knee arthritis
    E.1.2System Organ Class 100000004859
    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 pain and inflammatory parameters (cytokines, immune cells) in knee joint tissue of chronic arthritis pa-tients following intraarticular (i.a.) injections of morphine, a standard steroid or placebo.
    The primary hypothesis is that i.a. morphine results in sig-nificantly lower pain scores and supplemental analgesic consumption than placebo during the first week after injec-tion, an efficacy comparable to standard i.a. steroid (tri-amcinolone) medication.
    Primary efficacy endpoint:
    Reduction of pain intensity (on a 100mm VAS) at 8 a.m. on day 7 compared to baseline.
    Es werden Schmerz und Entzündungsparameter (Zytokine, Immunzellen) von Synovialgewebe des Kniegelenks bei Patienten mit chronischer Kniegelenkgsarthritis nach intra-artikulärer (i.a.) Applikation von Morphin, Triamcinolon oder Placebo untersucht.
    Die primäre Hypothese ist, dass in der ersten Woche nach lokaler Injektion durch i.a. Morphin ins Kniegelenk eine signifikante Schmerzreduktion (NRS Schmerz) und Reduk-tion der zusätzlichen Schmerztherapie im Vergleich zu Pla-cebo eintritt, ähnlich effektiv wie die Standardtherapie mit einem intraartikulären Steroid (Triamcinolon).
    Primärer Effektivitätsendpunkt:
    Schmerzreduktion auf einer 10 Punkte NRS um 8 Uhr mor-gens an Tag 7 im Vergleich zu Baseline
    E.2.2Secondary objectives of the trial
    Key secondary endpoint(s):
    Area under the VAS curve (AUC) during the first week until 8 p.m. on day 7. Pain intensity on McGill pain questionnaire (MPQ); daily activities; activity and mobility of the knee joint (Lysholm Gilquist-Score); WOMAC scale (before i.a. injec-tions and at the end of each week). Inflammatory parame-ters (cellular infiltrate, opioid receptors and peptides, IL-17, TNFα) in synovial biopsies and fluid (before and 7 days af-ter i.a. medication), supplementary analgesic consumption.
    Assessment of safety:
    Any systemic (e.g. nausea, sedation) and local side effects (infection, tissue injury) will be recorded.
    Wesentliche sekundäre Endpunkte:
    Area under the curve (AUC) während der ersten Woche bis 8 Uhr morgens an Tag 7 nach Baseline. Schmerzintensität anhand des McGill Schmerzfragebogens (MPQ); tägliche Aktivitäten, Aktivität und Mobilität des Kniegelenk (Lysholm Gilquist-Score); WOMAC Skala (vor der i.a. Injektion und am Ende von Woche 1 und 2). Entzündungsparameter (Zellin-filtrat, Opioidrezeptoren und Peptide, IL17, TNFα) in Syno-vialbiopsien und –flüssigkeit vor und 7 Tage nach der i.a. Medikation, zusätzliche Einnahme von Schmerzmedikation
    Sicherheitsassessments:
    Jegliche Systemische (z.B. Übelkeit, Sedierung) und lokale Nebenwirkungen (z.B. Infektion, Gewebedefekte) werden erfasst.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    1. Clinically detectable and/or ultrasound-visible knee ef-fusion as part of spondyloarthritis (Assessments in SpondyloArthritis international Society, ASAS criteria), Rheumatoid Arthritis, RA (according to American Col-lege of Rheumatology, ACR criteria), undifferentiated mono- or oligoarthritis, Osteoarthritis of the knee, OA.
    2. baseline pain score (on a 100 mm Visual Analogue Scale, VAS) >40 mm;
    3. male and female patients, age ≥18 - 80 years,
    4. body weight 50 - 90 kg.
    5. Able and willing to give a written informed consent and comply with the requirements of the study protocol.Only patients who give written informed consent will be included in the trial.
    6. If female: either not of child-bearing potential (meno-pausal since 1 year or surgically sterile) or is willing and able to practice a reliable method of contraception throughout the study with a pearl index <1. Reliable methods of contraception are: condoms plus other methods: implants, injecatbles, combined oral contracep-tives, intrauterine devices, initiated at least 90 days prior to screening. Further reliable methods are a vasecto-mised partner (at least 1 year prior to enrolment), sexual-ly abstinent, surgically sterilized (including hysterecto-my), postmenopausal defined as at least 1 year of spon-taneous amenorrhea (in questionable cases a blood sample with simultaneous levels of follicle stimulating hormone (FSH) above 40 U/l and estradiol below 30 nl/l is confirmatory).
    7. If male: either not of child-bearing potential (surgically sterilized, e.g. vasectomy) or is willing and able to prac-tice a reliable method of contraception with a pearl index <1 (see inclusion criterium 6) throughout the study.

    Einschlusskriteiren:
    1. Klinisch oder ultraschallgesteuert erkennbarer Kniege-lenkserguss im Rahmen einer Spondyloarthritis (ASAS Kriterien), RA (ACR Kriterien) unidfferenzierten Mono- oder Oligoarthritis, Gonarthrose.
    2. Baseline VAS Schmerz Score (auf einer 100 mm visuel-len Analogskala) > 40 mm.
    3. Männlich und weiblich, Alter 18 - 80 Jahre,
    4. Gewicht 50 - 90 kg.
    5. In der Lage und einverstanden, ein schriftliches Einver-ständnis zu geben sowie die Erfordernisse des Studi-enprotokolls einzuhalten. Nur Patienten, die ihre schriftliche Einwilligung gege-ben haben werden in die klinische Studie eingeschlossen.
    6. Für Frauen: die Patientin ist entweder nicht gebärfähig oder willigt ein, eine effektive Kontrazeptionsmethode mit einem Pearlindex < 1 während der gesamten Studie anzuwenden. Zuverlässige Methoden sind: Kondom plus andere Methoden: implantierte, Injizierte, kombi-nierte orale Kontrazeptiva, Intrauterinpessar, begonnen mindestens 90 Tage vor Baseline, vasektomierter Part-ner (mindestens 1 Jahr vor Baseline), abstinent, chirur-gisch sterilisiert inclusive Hysterektomie, post-menopausal definiert als mindestens 1 Jahr vor Baseli-ne Amenorrhoe (in fraglichen Fällen Blutergebnis mit gleichzeitig vorliegendem FSH über 40 U/l und Estradiol < 30 nl/l zur Bestätigung).
    7. Für Männer: der Patient ist entweder nicht zeugungsfä-hig oder willigt ein eine effektive Kontrazeptionsmetho-de mit einem Pearlindex <1 während der gesamten Stu-die anzuwenden.

    E.4Principal exclusion criteria
    Exclusion criteria:
    1. Severe cardiovascular, respiratory, metabolic, neurologi-cal, psychiatric disorders; current bacterial infection es-pecially of the knee
    2. abuse of analgesics, benzodiazepines, alcohol; “hard drugs”
    3. pregnancy, lactation
    4. before biopsy thrombocyte count < 100/nl, Quick <50%
    5. intake of anticoagulants, anti-aggregants as monothera-py such as ASS 100 will be allowed
    6. participation in an investigational trial during the last 30 days or 5 HLT whichever is longer
    7. treatment with intraarticular steroids during the past 4 weeks in the selected joint.
    8. Patients with a history of a severe psychiatric illness, which might interfere with the patient's ability to under-stand the requirements of the study and assessment.
    9. Patients who are institutionalised due to regulatory or juridical order. Patients who are an employee of the in-vestigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.
    10. Known hypersensitivity to any component of the study medication to morphine or triamcinolone, ileus, respira-tory depression, severe chronic obstructive airway dis-eases, acute abdomen, coagulopathy and/ or infections of the injection site, instability of the injected joint, psori-atic skin manifestation at the injection site, periarticular calcification, non-vascularized bone necrosis, tendon rupture, Charcot-joint.

    Ausschlusskritieren:
    1. Schwerwiegende kardiovaskuläre, respiratorische, me-tabolische, neurologische, psychiatrische Erkrankun-gen, aktuelle bakterielle Infektion insbesondere des Kniegelenks.
    2. Missbrauch von Analgetika, Benzodiazepinen, Alkohol.
    3. Schwangerschaft
    4. Vor der Synovialbiopsie: Thrombocyten < 100/nl, Quick <50%
    5. Einnahme von Antikoagulantien. Antiaggregation als Monotheraie wie z.B. ASS 100 ist erlaubt
    6. Teilnahme an einer anderen Arzneimittelstudie inner-halb der letzen 30 Tage oder innerhalb von 5 HWZ des vorangegangenen Studienmedikaments, was immer länger ist.
    7. Therapie mit intraartikulären Steroiden innerhalb der letzten 4 Wochen in das ausgewählte Gelenk.
    8. Jeder andere Umstand, der den Patienten nach Mei-nung des Prüfarztes für die Studie ungeeignet macht.
    9. Behördlich oder gerichtlich angeordnet institutionalisier-te Patienten. Patienten, die Angestellte des Prüfarztes oder des Prüfzentrums mit direkter Einbeziehung in die Studie oder andere Studien unter der Leitung des Prüfarztes, sowie Familienmitglieder des Prüfarztes oder des Arbeitgebers.
    10. Bekannte Hypersensitivität gegenüber Komponenten der Studienmedikation Morphin oder Triamcinolon. Ileus, Atemdepression, schwere COPD, akutes Abdo-men, Koagulopathie und/ oder Infektionen der Injekti-onsstelle, Instabilität des zu injizierenden Ge-lenks,Psoriasisläsion an der Injektionsstelle, periartiku-läre Kalzifizierung, nicht vaskularisierte Knochennekro-se, Sehnenruptur, Charcot-Gelenk.

    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint:
    Reduction of pain intensity (on a 100mm VAS) at 8 a.m. on day 7 compared to baseline.
    Primärer Effektivitätsendpunkt:
    Schmerzreduktion auf einer 10 Punkte NRS um 8 Uhr mor-gens an Tag 7 im Vergleich zu Baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 1
    Woche 1
    E.5.2Secondary end point(s)
    Area under the VAS curve (AUC) during the first week until 8 p.m. on day 7. Pain intensity on McGill pain questionnaire (MPQ); daily activities; activity and mobility of the knee joint (Lysholm Gilquist-Score); WOMAC scale (before i.a. injec-tions and at the end of each week). Inflammatory parame-ters (cellular infiltrate, opioid receptors and peptides, IL-17, TNFα) in synovial biopsies and fluid (before and 7 days af-ter i.a. medication), supplementary analgesic consumption.
    Assessment of safety:
    Any systemic (e.g. nausea, sedation) and local side effects (infection, tissue injury) will be recorded.
    Area under the curve (AUC) während der ersten Woche bis 8 Uhr morgens an Tag 7 nach Baseline. Schmerzintensität anhand des McGill Schmerzfragebogens (MPQ); tägliche Aktivitäten, Aktivität und Mobilität des Kniegelenk (Lysholm Gilquist-Score); WOMAC Skala (vor der i.a. Injektion und am Ende von Woche 1 und 2). Entzündungsparameter (Zellin-filtrat, Opioidrezeptoren und Peptide, IL17, TNFα) in Syno-vialbiopsien und –flüssigkeit vor und 7 Tage nach der i.a. Medikation, zusätzliche Einnahme von Schmerzmedikation
    Sicherheitsassessments:
    Jegliche Systemische (z.B. Übelkeit, Sedierung) und lokale Nebenwirkungen (z.B. Infektion, Gewebedefekte) werden erfasst.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 1, week 2, safety follow up week 3
    Woche 1, Woche 2, Sicherheits Follow Up Woche 3
    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 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 Yes
    E.6.13.1Other scope of the trial description
    To investigate pain and inflammatory parameters (cytokines, immune cells) in knee joint tissue of chronic arthritis pa-tients following intraarticular (i.a.) injections of morphine, a standard steroid or placebo.
    Es werden Schmerz und Entzündungsparameter (Zytokine, Immunzellen) von Synovialgewebe des Kniegelenks bei Patienten mit chronischer Kniegelenkgsarthritis nach intra-artikulärer (i.a.) Applikation von Morphin, Triamcinolon oder Placebo untersucht.
    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 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) Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 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 end of the trial is the last visit of the last subject.
    Studienende ist, wenn der letzte Patient die letzte Visite durchlaufen hat.
    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 months
    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 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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-04-07. Yes
    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 state
    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 trial the patients undergo standard care.
    Nach der Studie warden die Patienten nach klinischem Standard weiterbehandelt.
    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 Decision2015-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-08-27
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    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
    EMA HMA