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    Summary
    EudraCT Number:2017-003307-21
    Sponsor's Protocol Code Number:848016005-02
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-12-19
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-003307-21
    A.3Full title of the trial
    Tailored treatment of functional dyspepsia with nortriptyline: a multi-center double-blind placebo-controlled trial (TENDER)
    Gepersonaliseerde behandeling van functionele dyspepsie met nortriptyline: een dubbelblind placebo gecontroleerde studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Personalized treatment of functional dyspepsia with nortriptyline
    Gepersonaliseerde behandeling van functionele dyspepsie met nortriptyline
    A.3.2Name or abbreviated title of the trial where available
    TENDER
    A.4.1Sponsor's protocol code number848016005-02
    A.5.4Other Identifiers
    Name:METC-nummerNumber:173051
    Name:NL-nummerNumber:62932.068.17
    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 SponsorMaastricht University
    B.1.3.4CountryNetherlands
    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 supportZonMw
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaastricht University Medical Center
    B.5.2Functional name of contact pointApplicant
    B.5.3 Address:
    B.5.3.1Street AddressP. Debyelaan 25
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6229 HX
    B.5.3.4CountryNetherlands
    B.5.6E-maila.masclee@mumc.nl
    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 Nortrilen
    D.2.1.1.2Name of the Marketing Authorisation holderLundbeck B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 Yes
    D.2.1.1.1Trade name Nortrilen
    D.2.1.1.2Name of the Marketing Authorisation holderLundbeck B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 Yes
    D.2.1.1.1Trade name Nortrilen
    D.2.1.1.2Name of the Marketing Authorisation holderLundbeck B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 placeboCapsule
    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
    Functional dyspepsia (FD)
    Functionele dyspepsie (FD)
    E.1.1.1Medical condition in easily understood language
    Functional dyspepsia (FD) is a gastrointestinal disorder characterized by epigastric pain or discomfort and/or bloating or early satiety.
    Functionele dyspepsie is een vaak voorkomende stoornis van het maag-darmstelsel. De kenmerken zijn ongemak of pijn in de maagstreek en/of een opgeblazen gevoel of vroege verzadiging na de maaltijd.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of an escalating dose regimen of nortriptyline as compared to placebo in FD patients without evidence of significant psychiatric disease, that have been identified as extensive metabolizers based on their CYP2D6 genotype
    Het bepalen van de effectiviteit van behandeling met nortriptyline bij FD patiënten, geïdentificeerd als CYP2D6 extensive metabolizers, zonder onderliggende psychiatrische stoornis, in vergelijking met placebo.
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of treatment on quality of life, as compared to placebo.
    2. To evaluate the cost-effectiveness of treatment, as compared to placebo.
    3. To evaluate the effect of treatment after discontinuation, as compared to placebo.
    4. To evaluate side-effects of nortriptyline as compared to placebo
    1. Het evalueren van het effect van behandelingop de kwaliteit van leven, in vergelijking met placebo.
    2. Het evalueren van de kosten-effectiviteit van behandeling, in vergelijking met placebo.
    3. Het evalueren van de effect van behandeling nadat deze gestaakt is, in vergelijking met placebo.
    4. Het evalueren van de bijwerkingen van nortriptyline in vergelijking met placebo.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    An open label extension of the current study is specified in the study protocol in Addendum A (version 2.6, date August 12 2019):

    In the sub-study we aim to offer open label nortriptyline treatment to FD patients recognized as poor or intermediate metabolizer. Ultrarapid metabolizers will not be eligible for this open label extension.

    Hypothesis: We hypothesize that treatment with the second generation TCA nortriptyline (open label) results in adequate relief of symptoms in FD in patients with predicted poor or intermediate metabolizing capacity for CYP2D6.

    Primary objective:
    1. To explore the efficacy of low dose (10 mg) nortriptyline in FD patients without evidence of significant psychiatric disease, that have been identified as poor or intermediate metabolizers based on their CYP2D6 genotype.

    Secondary objectives:
    In addition to the objectives described in section 2, we aim to explore the relationship between CYP2D6 genotype and nortriptyline plasma levels at week 1 of treatment, when dosages are similar in all nortriptyline regimens (i.e. 10mg)

    Open label treatment
    Patients that are recognized as poor or abnormal metabolizers will be offered nortriptyline in a dose of 10 mg (open label), as customary in regular clinical care. No more than 10 mg dose will be administered to mitigate the occurrence of potential side effects.

    Prescriptions and regular follow-up will be performed by the treating physician. Treatment duration will generally be 12 weeks, which is regarded routine clinical practice. When deemed necessary by the treating physician, treatment duration may be longer (or shorter).
    During the treatment period, the same study procedures as described in section 8.3 will be applicable (with the exception of randomisation). After treatment, the follow-up period will encompass the same study procedures (i.e. completion of questionnaires). After completion of the follow-up period, patients will receive the same monetary reward as patients in the randomized setting (i.e. 150 euros). Finally, the total number of inclusions will not exceed the pre-calculated sample size described in section 4.5 (i.e. 154 subjects). This open label extension is entirely exploratory and therefore no additional sample size calculation was performed.
    E.3Principal inclusion criteria
    - Patients with functional dyspepsia (FD), diagnosed according to the Rome IV criteria
    - Age 18-65 years
    - Predicted CYP2D6 extensive metabolizer phenotype on the basis of CYP genotyping
    - In the presence of alarm symptoms, patients are required to have undergone a upper gastrointestinal endoscopy (without evidence of organic disease), and have tested negative for Helicobacter pylori 2 years prior to inclusion.
    - Insufficient effect of first line treatment with proton pump inhibitors or prokinetics.
    - Women in their fertile age (<55 years old) must use contraception or be postmenopausal for at least two years.

    Patients are recruited in primary and secondary/tertiary healthcare settings.
    - Diagnose functionele dyspepsie op basis van Rome IV criteria
    - Leeftijd tussen de 18 en 65 jaar
    - Voorspeld CYP2D6 extensive metabolizer fenotype op basis van genotypering
    - Bij alarmsymptomen: negatieve gastroduodenoscopie en negatieve helicobacter pylori test in periode 2jaar voorafgaande aan de studie.
    - Onvoldoende effect op eerstelijns therapie. - Vrouwen in vruchtbare levensfase worden gevraagd anticonceptie te gebruiken

    Patiënten worden geïncludeerd in 1e en 2e/3e lijn zorg.
    E.4Principal exclusion criteria
    - History of gastric ulcer;
    - Evidence of current anxiety and/or depression disorder as defined by a score ≥ 10 on the GAD-7 and/or PHQ-9 questionnaire, supported by a detailed interview by the investigator (i.e. the investigator is required to confirm suspicion of anxiety or depressive disorder);
    - Predicted CYP2D6 poor, intermediate or ultrarapid metabolizer phenotype on the basis of CYP genotyping
    - Current use or any previous use of psychotropic medication in the last 3 months prior to inclusion;
    - Inability to discontinue prokinetics*, NSAIDs or opioids;
    - Excessive alcohol consumption, defined as > 2 of 3 units per day (females and males respectively)
    - Using drugs of abuse;
    - Previous major abdominal surgery or radiotherapy interfering with gastrointestinal function:
    a. Uncomplicated appendectomy, cholecystectomy and hysterectomy allowed unless within the past 6 months;
    b. Other surgery upon judgment of the principle investigator;
    - History of liver disease, cholangitis, achlorhydria, gallstones or other diseases of the gallbladder/biliary system;
    - Pregnancy or lactation.
    - History of epilepsy
    - History of glaucoma

    * Patients still using prokinetics at the time of inclusion will be asked to discontinue treatment. A wash-out period of 2 weeks before the run-in period is required. Patients that cannot discontinue prokinetic therapy will be excluded. Patients on proton pump inhibitors should continue these without altering dosage, given that rebound symptoms can occur with discontinuation.
    - Maagzweer in het verleden,
    - Voorspeld poor, intermediate of ultrarapid metabolizer fenotype op basis van CYP genotypering
    - Aanwijzingen voor angststoornis of depressie (GAD-7 of PHQ-9 score 10 of hoger, aangevuld met een interview door de onderzoeker, welke het vermoeden op een angststoornis of depressie dient te bevestigen)
    - Huidig gebruik van psychotrope medicatie of 3 maanden voor inclusie
    - Onvermogen prokinetica*, opiaten of NSAIDs te staken
    - Gebruik van drugs
    - Eerdere grotere abdominale chirurgie of radiotherapie die met de gastrointestinale functie kan interfereren. Toegestaan zijn ongecompliceerde cholecystectomie, hysterectomie of appendectomie, mits eerder dan 6 maanden voor inclusie.
    - zwangerschap of het geven van borstvoeding
    - bekend met epilepsie
    - bekend met glaucoom

    * patienten die nog prokinetica gebruiken op het moment van inclusie worden verzocht deze te staken. Een washout van 2 weken wordt gehanteerd vooraleer patienten kunnen deelnemen aan de run-in. Voor PPIs geldt dat patienten verzocht worden deze te continueren in de dosis zoals op het moment van inclusie.
    E.5 End points
    E.5.1Primary end point(s)
    Response to therapy, as defined by a 30% reduction from baseline (i.e. the run-in period) in the weekly average of daily symptom scores, during at least 50% of weeks 3-12 of treatment. This is in line with the FDA guidelines on IBS treatment studies. Recorded symptoms include the five core symptoms of FD: epigastric pain, epigastric burning, postprandial fullness, early satiety and upper abdominal bloating.
    Weeks 1 and 2 are excluded in order to allow for establishment of steady-state drug levels
    Response gedefinieerd als een 30% reductie ten opzichte van baseline in het wekelijks gemiddelde van symptoomscores, gedurende ten minste 50% van de weken 3-12 van behandeling. De gerapporteerde symptomen zijn de 5 core symptomen van functionele dyspepsie, zoals omschreven in de recent ontwikkelde FD diary.
    Week 1 en 2 worden buiten beschouwing gelaten omdat gedurende deze periode eerst een "steady-state" van het medicijn bereikt moet worden.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weekly evaluation
    Wekelijkse evaluatie
    E.5.2Secondary end point(s)
    - Self-reported weekly global adequate relief of symptoms (defined as a "yes" in at least 50% of weeks 3-12 of the treatment), collected
    electronically. Weeks 1 and 2 are excluded in order to allow for establishment of steady-state drug levels
    - Quality of life, assessed with the use of the EQ-5D-5L (change from baseline).
    - Dyspepsia-specific quality of life, assessed with the use of the Nepean Dyspepsia Index (change from baseline).
    - Cost-utility, as determined by calculations incorporating total treatment costs and changes in EQ-5D-5L (QALYs gained) and MCQ/PCQ results (savings from reduced medical resource use and increased work productivity respectively).
    - Use of rescue medication.
    - Number and severity of side effects
    - Responder rates following discontinuation of treatment at 6 months follow-up, as defined by a “Yes” to the query regarding adequate relief from baseline symptoms.
    - Worst-case-analysis: imputing a non-response day for each day on which the electronic diary entry was missing (due to non-reporting of the patient) in patients assigned to nortriptyline; in patients assigned to placebo, a response day will be imputed for each day the electronic diary entry was missing.
    - (Negative) mood; assessed with the use of the PHQ-9 and GAD-7 (change from baseline).
    1 - Patiënt gerapporteerde globale verlichting van klachten (gedefinieerd als een "ja" in ten minste 50% van de weken 3-12 van de behandeling).
    De antwoorden worden elektronisch verzameld.
    2 - Dyspepsie specifieke kwaliteit van leven (NDI)
    3 - Kwaliteit van leven (EQ-5D-5L)
    4 - Kosten effectiviteit (gebaseerd QALY toename, gezondheidszorg consumptie (MCQ) en werkproductiviteit (PCQ) en behandel kosten)
    5 - Gebruik van rescue medicatie
    6 - Aantal bijwerkingen
    7 - Response 6 maanden na staken van behandeling (follow-up), gedefinieerd als een "ja" response op de vraag of de patient verlichting heeft ervaren van zijn/haar klachten tov baseline
    8 - Worst-case analyse. Hierbij wordt een non-response ingevoerd bij patiënten op nortriptyline wanneer er geen data is; bij placebo vice versa.
    9 - (negatieve stemming); beoordeeld met behulp van de PHQ-9 en de GAD-7 (verandering tov baseline).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 - Daily symptom evaluation (symptom diary) with calculation of symptom average at the end of treatment
    2 Prior to initiation of the treatment period, at 12 weeks and at 3 and 6 months follow-up
    3 Prior to initiation of the treatment period, at 4, 8, 12 weeks and at 3 and 6 months follow-up
    4 for MCQ: Prior to initiation of the treatment period, at 12 weeks and at 3 and 6 months follow-up
    4 for PCQ: Prior to initiation of the treatment period, at 4, 8, 12 weeks and at 3 and 6 months follow-up
    5 + 6 - daily evaluation
    7 - at follow-up
    8 - end of treatment
    9 - Prior to initiation of the treatment period, at 12 weeks of treatment and at 3 and 6 months follow-up
    1 - dagelijkse symptoom evaluatie met calculatie van gemiddelde aan einde van behandeling
    2 - voor de start van de behandelperiode, na de behandeling (week 12) en + follow-up (3 en 6 maanden)
    3 - voor de start van de behandelperiode en in week 4, 8, 12 + follow-up (3 en 6 maanden)
    4 - in geval van MCQ: voor de start van de behandelperiode, na de behandeling (week 12) en + follow-up (3 en 6 maanden)
    4 - in geval van PCQ: voor de start van de behandelperiode en in week 4, 8, 12 + follow-up (3 en 6 maanden)
    5 + 6 - dagelijkse evaluatie
    7 - bij follow-up
    8 - aan het einde van de behandelperiode
    9- Voor de start van de behandeling, na 12 weken behandeling + follow-up (3 en 6 maanden)
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned8
    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 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 years
    E.8.9.1In the Member State concerned months36
    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: 154
    F.1.3Elderly (>=65 years) No
    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 state154
    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)
    None
    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 Decision2017-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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