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   36079   clinical trials with a EudraCT protocol, of which   5931   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-003052-70
    Sponsor's Protocol Code Number:APAC2016
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-09-19
    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 number2016-003052-70
    A.3Full title of the trial
    Initial non-operative treatment strategy versus appendectomy treatment strategy for simple appendicitis in children aged 7-17 years old. APAC study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Initial non-operative treatment versus direct operative treatment for simple appendicitis in children
    A.4.1Sponsor's protocol code numberAPAC2016
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02848820
    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 SponsorAcademic Medical Center of Amsterdam
    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 organisationRamon Gorter
    B.5.2Functional name of contact pointCoordinating investigator
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1100DD
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031205665693
    B.5.5Fax number0031205669287
    B.5.6E-mailrr.gorter@vumc.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 Amoxicillin/clavulanic acid
    D.2.1.1.2Name of the Marketing Authorisation holderPharmachemie
    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 Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMOXICILLIN
    D.3.9.1CAS number 26787-78-0
    D.3.9.2Current sponsor codeAmoxiAPAC2016
    D.3.9.4EV Substance CodeSUB05481MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLAVULANIC ACID
    D.3.9.1CAS number 58001-44-8
    D.3.9.2Current sponsor codeClavuAPAC2016
    D.3.9.4EV Substance CodeSUB06642MIG
    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 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 Amoxicillin/clavulanic acid
    D.2.1.1.2Name of the Marketing Authorisation holderMylan
    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.3.1Product nameAugmentin
    D.3.4Pharmaceutical form Oral suspension
    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 INNAMOXICILLIN
    D.3.9.1CAS number 26787-78-0
    D.3.9.2Current sponsor codeAmoxiAPAC2016
    D.3.9.4EV Substance CodeSUB05481MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLAVULANIC ACID
    D.3.9.1CAS number 58001-44-8
    D.3.9.2Current sponsor codeClavuAPAC2016
    D.3.9.4EV Substance CodeSUB06642MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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 Gentamicin
    D.2.1.1.2Name of the Marketing Authorisation holderCentrafarm
    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.3.1Product nameGentamicin
    D.3.4Pharmaceutical form Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGENTAMICIN SULFATE
    D.3.9.1CAS number 1405-41-0
    D.3.9.2Current sponsor codeGentaAPAC2016
    D.3.9.4EV Substance CodeSUB02327MIG
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute uncomplicated (simple) appendicitis
    E.1.1.1Medical condition in easily understood language
    Acute uncomplicated appendicitis
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10003011
    E.1.2Term Appendicitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this study is to compare the effectiveness of initial non-operative treatment strategy (reserving appendectomy for those not responding or with recurrent disease) with immediate appendectomy in children from 7-17 years old, inclusive, with acute simple appendicitis in terms of complications, health related QOL and costs.

    Main research question:
    What is the difference in proportion of patients experiencing complications within one year between both strategies in children from 7-17 years old, inclusive, with acute simple appendicitis
    E.2.2Secondary objectives of the trial
    Secondary objectives consist of:
    Number of days absent from school, social or sport events (patient-level)
    Number of days absent from work (parents-level)
    Total number of extra visits (not the already scheduled ones) for abdominal pain.
    Total length of hospital stay
    Level of pain
    Pain medication utilization
    Proportion of patients with missed diagnosis of complex appendicitis with risk of peritonitis, not having to undergone appendectomy, experiencing recurrent appendicitis.

    Proportion of patients experiencing early failure of initial non-operative treatment, that undergo interval appendectomy or experiencing complications

    Quality of life measured by the validated CHQ-CF87, EQ-5d-Youth, EQ-5d-Proxy questionnaire.
    Medical, non-medical and indirect costs at one year follow up
    Patient satisfaction measured by the NET PROMOTOR SCORE and validated Patient Satisfaction Questionnaire (PSQ)18.
    Factors influencing implementability
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Eligible for inclusion are all children from 7 to 17 years old, inclusive, with a radiologically confirmed simple appendicitis. Definition of simple appendicitis is based upon predefined clinical, biochemical and radiological (ultrasound) criteria.
    Clinical & biochemical criteria:
    - Unwell but not generally ill
    - Localized tenderness in the right iliac fossa region
    - Normal/hyperactive bowel sounds
    - No guarding or palpable mass
    - Biochemical signs of infection (Elevated White Blood Cell count (WBC) and/or C-reactive protein (CRP)).
    As recommended by the national guideline, all children with a clinical and/or biochemical suspicion should undergo ultrasound studies. Ultrasound criteria to confirm the diagnosis of acute simple appendicitis are:
    - An incompressible, painful appendix with an outer diameter > 6 mm
    - Secondary signs of inflammation such as surrounding fat infiltration, limited clear free fluid surrounding the appendix, hyperemia within the appendiceal wall.
    - No fecolith, no signs of perforation, no signs of intra-abdominal abscess or phlegmone.
    In case the ultrasound is inconclusive, additional imaging studies may be obtained. CT-scan is not recommended in the young children (due to its risk of radiation induced malignancy). MRI is recommended in those places with sufficient experience in the interpretation of the results. Only those in whom imaging studies confirm the diagnosis of simple appendicitis can be included. In case there is no certain diagnosis and a “watchful waiting” strategy is chosen, the patient cannot be included.
    E.4Principal exclusion criteria
    Exclusion criteria:
    • Generalized peritonitis, complex appendicitis or sepsis (based upon predefined criteria and scoring system). [21,22]
    Scoring system: As scoring system was developed determining the risk of complex appendicitis based upon five pre-operative variable. Points have been awarded to each variable. In case the total score is less than 4 points, the patient is likely to have a simple appendicitis. In case the score is 4 or more points, the chance of having complex appendicitis is significant and those children will be excluded from this study. Variables:
    Diffuse abdominal guarding (3 points)
    CRP level more than 38 mg/L (2 points)
    Signs on ultrasound indicative of complex appendicitis (2 points)
    More than one day abdominal pain (2 points)
    Temperature: more than 37.5 degree Celsius (1 point)
    • Fecolith (ultrasound)
    • Serious co-morbidity
    • Recurrent appendicitis
    • Suspicion of an underlying malignancy or inflammatory bowel disease
    • Documented type 1 allergy to the antibiotics used.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is the proportion of patients experiencing complications within one year follow-up. An adjudication committee will be installed to review the complications. They will review all patients with possible complications to determine whether or not they fulfill the criteria for complications. All Complications will be recorded.
    Complications are defined as:
    • Allergic reaction to antibiotics administered. In case an allergic reaction is suspected, the child will be referred to the allergist for further evaluation.
    • Re-admission for an indication other than recurrent appendicitis but related to appendicitis (such as readmission for observation of fever or abdominal pain)
    • Complications associated with appendectomy:
    - Superficial Site infection
    - Intra-abdominal abscess
    - Stump leakage/stump appendicitis
    - Secondary / prolonged Bowel Obstruction
    - Anesthesia Related complications (such us pneumonia)
    - Hernia cicatricalis
    - Need for other surgical or radiological intervention than appendectomy but related to appendicitis (such as percutaneous drainage of an abscess, surgical intervention for a superficial site infection)
    Recurrent appendicitis sometimes referred to as ‘failure of initial non-operative treatment strategy’ should not be regarded as complication, as this is a potential consequence of the initial non-operative treatment strategy in some patients.
    E.5.1.1Timepoint(s) of evaluation of this end point
    One-year after initial treatment
    E.5.2Secondary end point(s)
    Day 7
    Proportion of patients experiencing early failure of initial non-operative treatment, defined as the need to undergo an appendectomy during the antibiotic course (iv or oral) due to clinical deterioration, lack of improvement or fecolith.
    Pain score measured by the Visual Analogue Score (validated for children older than 7 years old) during clinical phase
    Pain medication utilization during the first seven days after admission.

    After one month:
    Proportion of patients with missed diagnosis of complex appendicitis

    At one month, six months and one year follow-up:
    Number of days absent from school, social or sport events
    Number of days absent from work (parents)
    Number of extra visits to the outpatient clinic, general practitioners office or emergency department for abdominal pain.
    Total number of days as an inpatient in hospital during the one year follow-up period for strategy related treatment or complications
    Proportion of patients not having undergone appendectomy
    Proportion of patients experiencing recurrent appendicitis, defined as histopathologically confirmed appendicitis after appendectomy
    Proportion of patients experiencing complications at six and 12 months follow up
    Proportion of patients that undergo interval appendectomy, defined as undergoing an appendectomy with a low clinical and radiological suspicion of recurrent appendicitis and no signs of appendicitis upon histopathological examination.

    Health-related Quality of Life measured by the(disease specific) Child Health Questionnaire –Child Form 87 (CHQ-CF87) and the (generic) European Quality of Life-5 Dimensions-Youth (EQ-5d-Y) (Child perspective) and European Quality of life-5 Dimensions-Proxy (EQ-5D-Proxy)(Parents perspective). The CHQ-CF87 is a validated multi-dimensional questionnaire to assess the health related (disease specific) quality of life in children 5-18 years old. It contains the dimensions of physical functioning, role/social limitations-emotional, role/social limitations-behavioral, role/social limitations-physical, bodily pain/discomfort, behavior, mental health, self esteem, general health perception and family activities. The EQ-5D-Y is a modified version of the EQ-5D specific for children. The adult version (EQ-5D) has been designed as a generic instrument for measuring health related quality of life, in particular utility. It is recommended for use in cost-effectiveness and cost-utility studies. For parents’ perspective, the EQ-5D-Proxy will be used.

    Medical, non-medical and indirect costs.
    iMCQ and iPCQ will be used to measure the direct and indirect costs of health care utilization, and days absent from work and school by both the parents and children. Costs will be calculated using the answers from the iMCQ and iPCQ. Actual health care costs will be gathered based upon the actual used health care in our study. Variables gathered will be, but not limited to number of follow up out-patient clinic visits, number of general practitioners visits, number of emergency department visits, absenteeism from work and travel expenses.

    Patient satisfaction will be measured by the NET PROMOTOR SCORE and Patient Satisfaction Questionnaire (PSQ) 18. Both have been validated in the general population. Proxy-assessments will be obtained from the parents.

    Outcomes will be measured at discharge, 7 days, 1, 6, and 12 months after randomization as described above. The follow up measurements at 7 days, 6 and 12 months will be done by email and telephone.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See the above mentioned time points of evaluation
    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 No
    E.6.5Efficacy No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Appendectomy
    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 concerned15
    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
    Last follow up by telephone at 12 months after discharge of last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 Yes
    F.1.1Number of subjects for this age range: 334
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 167
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 167
    F.1.2Adults (18-64 years) No
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    In this trial, children aged 7-17 years old will be participating. Informed consent from:
    In case the patient is < 12: Legal guardians
    In case the patient is 12-17 years old: Legal guardians + patient
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state334
    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 Decision2016-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-10
    P. End of Trial
    P.End of Trial StatusOngoing
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA