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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:2016-003428-21
    Sponsor's Protocol Code Number:ABPOSTOPAPP
    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:2016-12-08
    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 number2016-003428-21
    A.3Full title of the trial
    Non-inferiority multicentre randomized controlled trial comparing short versus standard course postoperative antibiotic treatment for complex acute appendicitis
    Non-inferiority, multicenter gerandomiseerde studie waarbij een kortdurende versus standaard postoperatieve antibioticabehandeling wordt vergeleken bij complexe acute appendicitis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial investigating duration of postoperative antibiotic treatment for complicated appendicitis (inflammation of the appendix)
    Studie naar duur van postoperatieve behandeling met antibiotica voor complexe blindedarmontsteking.
    A.3.2Name or abbreviated title of the trial where available
    APPIC trial (Antibiotics following aPPendectomy In Complex appendicitis)
    A.4.1Sponsor's protocol code numberABPOSTOPAPP
    A.5.4Other Identifiers
    Name:NL59492.078.16Number:NTR6128
    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 SponsorErasmus Medical Centre
    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 organisationErasmus Medical Centre
    B.5.2Functional name of contact pointDrs. E.M.L. de Wijkerslooth
    B.5.3 Address:
    B.5.3.1Street Address's Gravendijkwal 230
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 CE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031107034519
    B.5.6E-maile.dewijkerslooth@erasmusmc.nl
    D. IMP Identification
    D.IMP: 1
    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 Cefuroxime (Zinacef)
    D.2.1.1.2Name of the Marketing Authorisation holderHikma Farmaceutica (Portugal), S.A.
    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 nameCefuroxime (Zinacef)
    D.3.2Product code RVG 20590
    D.3.4Pharmaceutical form Powder for solution for injection
    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 INNCEFUROXIME SODIUM
    D.3.9.1CAS number 56238-63-2
    D.3.9.4EV Substance CodeSUB01140MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Metronidazole (Flagyl)
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter 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.3.1Product nameMetronidazole (Flagyl)
    D.3.2Product code RVG 17393
    D.3.4Pharmaceutical form Solution for injection/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 INNMETRONIDAZOLE
    D.3.9.3Other descriptive nameMetronidazole (Flagyl) 500 mg/100 ml suspension for intravenous use (5mg/ml)
    D.3.9.4EV Substance CodeSUB08922MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 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 Ceftriaxone (Rocephin) Name specified by MAH: Ceftriaxon Fresenius Kabi 2 g
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Nederland BV
    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 Powder 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 INNCEFTRIAXONE
    D.3.9.1CAS number 73384-59-5
    D.3.9.4EV Substance CodeSUB07431MIG
    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 Yes
    D.3.11.13.1Other medicinal product typeAntibiotic: third generation cephalosporine.
    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
    Complex appendicitis.
    Complexe appendicitis
    E.1.1.1Medical condition in easily understood language
    Complicated inflammation of the appendix.
    Gecompliceerde blindedarmontsteking.
    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
    The goal of this study is to evaluate efficacy and safety of stopping postoperative antibiotic treatment after 48 hours of intravenous therapy versus continuing for three more days (to complete a total of five days which is common practice), following appendectomy in patients suffering from complex appendicitis.
    Het doel van de studie is om de effectiviteit en veiligheid te evalueren van een kortdurend postoperatief antibioticaschema (48u) ten opzichte van het huidige standaard schema (5 dagen) na appendectomie voor complexe appendicitis
    E.2.2Secondary objectives of the trial
    Secondary objectives are to compare between both trial arms :
    - intra-abdominal abscess rate
    - superficial and/or deep surgical site infections rate
    - overall postoperative complication rate & severity
    - duration of postoperative antibiotic treatment
    - re-start of antibiotics
    - adverse events on antibiotics
    - hospital stay in hours from the operation
    - time to reach discharge criteria in hours from the operation
    - postoperative imaging for suspected complication
    - emergency room visits and readmission rate
    - cost-effectiveness
    All within 90 days after appendectomy.
    Secundaire eindpunten zijn om te vergelijken tussen beide studie-armen:
    - intra-abdominale abcessen
    - oppervlakkige en diepe wondinfectie
    - postoperatieve complicaties en ernst
    - duur van postoperatieve antibioticabehandeling
    - herstart van antibiotica
    - bijwerkingen van antibiotica
    - opnameduur (in uren vanaf operatie)
    - tijd tot bereiken ontslagcriteria (in uren vanaf operatie)
    - postoperatieve beeldvorming voor verdenking op complicaties
    - bezoeken aan de eerste hulp en heropnames
    - kosten-effectiviteit
    Allen binnen 90 dagen na appendectomie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - age minimum 8 years old (no upper limit)
    - patients with suspected acute appendicitis, awaiting appendectomy
    - written informed consent
    - intraoperative diagnosis of a complex appendicitis
    - leeftijd ouder dan 8 jaar
    - patienten met verdenking op acute appendicitis, in afwachting van appendectomie
    - geschreven informed consent
    - intraoperatieve diagnose complexe appendicitis
    E.4Principal exclusion criteria
    - appendectomy à froid
    - not able to give informed consent
    - severe sepsis, defined as sepsis-induced tissue hypoperfusion or organ dysfunction
    - conservative treatment of acute appendicitis
    - ASA score IV or not able to undergo surgery
    - known allergy or any other contraindication for the use of the study medication
    - immunocompromised patients
    - pregnancy
    - use of other antibiotics for other reason than mentioned in above.
    - simple acute appendicitis
    - intraoperative appendicular infiltration not amendable for appendectomy
    - inadequate source control during operation.
    - appendectomie a froid
    - niet in staat informed consent te geven
    - ernstige sepsis
    - conservatieve behandeling appendicitis
    - ASA score IV of niet in staat operatie te ondergaan
    - bekende allergie of enige andere contraindicatie voor de studiemedicatie
    - immuungecompromiteerde patienten
    - gebruik van andere antibiotica
    - intraoperatieve diagnose simpele appendicitis
    - intraoperatief een appendiculair infiltraat niet geschikt voor appendectomie
    - inadequate source control tijdens operatie
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is a composite endpoint of mortality and postoperative infectious complications related to complex appendicitis, including intra-abdominal abscess and both deep and superficial surgical site infections within 90 days. A detailed definition of intra-abdominal abscess (IAA) and surgical site infection (SSI) according to the Center for Disease Control (CDC) criteria is given in chapter 8 of the studyprotocol.
    De primaire uitkomstmaat is een samengesteld eindpunt van mortaliteit, intra-abdominale abcessen en diepe- en oppervlakkige wondinfecties binnen 90 dagen. Een gedetailleerde definitie van het primaire eindpunt vindt u in het studieprotocol in hoofdstuk 8 Methods, op pagina 29.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Follow-up until 90 days after appendectomy.
    Follow-up t/m 90 dagen na appendectomie.
    E.5.2Secondary end point(s)
    Secundary outcomes are amongst others: intra-abdominal abscess, superficial and/or deep surgical site infections, restart of antibiotics, hospital stay in hours, readmission rate and cost-effectiveness.

    Study variables are: age at time of diagnosis, location of operation, medical history (including diabetes mellitus, corticosteroid use), ASA score, gender, BMI, body temperature and laboratory results at time of presentation (CRP, WBC, eGFR), diagnostic radiological imaging, duration and severity of abdominal pain (VAS scale), antibiotic use prior to clinical diagnosis of acute appendicitis (type and dosage), prophylactic antibiotic use (type and dosage), laparoscopic or open appendectomy, duration of operation (skin-to-skin time), type of appendicitis (phlegmonous, gangrenous or perforated, with or without abscess), degree of peritonitis, level of expertise of surgeon, peritoneal irrigation and/or suction, wound management, use of (endo)loops or (endo)stapler, intraperitoneal drain placement, cultures of intra-abdominal fluid collections, histological type of appendicitis, (time to reach) discharge criteria, postoperative imaging for suspected complications, intra-abdominal abscess (IAA), deep and/or superficial surgical site infection (SSI), treatment of IAAs and SSIs, any other postoperative complication including severity, duration and doses of antibiotics received, restart of antibiotics and type, adverse events on antibiotics, type and resistance profile of cultured micro-organisms postoperatively, length of hospital stay, post-operative outpatient visit, readmission, re-interventions for complications (all within 90 days after appendectomy).
    Secundaire uitkomstmaten zijn o.a.: intra-abdominale abccessen (IAA), wondinfecties (SSI), duur van opname, herstart van antibiotica, heropname en kosteneffectiviteit.

    Studievariabelen zijn: leeftijd ten tijde van diagnose, locatie van operatie, voorgeschiedenis patient (incl. diabetes mellitus, corticosteroidengebruik), ASA score, geslacht, body mass index (BMI), lichaamstemperatuur en bloedwaarden ten tijde van presentatie presentation (C-reactive protein (CRP), leukocyten), preoperatieve echografie of andere beeldvormende technieken, duur en ernst van buikpijn (VAS score of analgetische behoefte), gebruik van profylactische antibiotica peroperatief (type and dosering), laparoscopische or open appendectomie, operatieduur (snijtijd), perioperatieve ernst/type van appendicitis, level van expertise chirurg (arts-assistent in opleiding, specialist, type specialisatie), gebruik van (endo)loops of (endo)stapler, kweken, histologisch type appendicitis, ontslagcriteria, postoperatieve beeldvorming voor verdenking op complicaties, alle complicaties (volgens Clavien-Dindo classificatie), intra-abdominale abcessen (IAA), diepe en/of oppervlakkige wondinfecties (SSI), behandeling van IAA en/of SSI, totale opnameduur, postoperatieve poliklinische bezoek(en), heropnames, reinterventies (allen binnen 90 dagen na appendectomie).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Also follow-up until 90 days after appendectomy.
    Tevens follow-up t/m 90 dagen na appendectomie.
    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
    Duration of therapy.
    Duur van therapie.
    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
    Interventie: staken antibiotica na 48 uur, comparator: antibiotica 3 dagen voortzetten (5dgn totaal)
    Intervention: discontinuing antibiotics after 48hrs. Comparator: continuing 3 more days (5dys total)
    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 concerned14
    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
    a) when the targeted number of 1066 patients has been reached; or
    b) if one of the stopping rules is reached as defined in the studyprotocol and DSMB Charter.
    Het einde van de studie is wanneer:
    a) het beoogde aantal van 1066 patienten inclusies is bereikt; of
    b) wanneer een van de stopregels bereikt is, zoals beschreven in het studieprotocol en het DSMB Charter.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months9
    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: 375
    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: 75
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 300
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 916
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 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 2016-12-08. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Children from 8 years of age can be included in the trial.
    Kinderen vanaf 8 jaar oud kunnen worden geïncludeerd in deze trial.
    F.4 Planned number of subjects to be included
    F.4.1In the member state1066
    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
    Geen
    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 Decision2016-12-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-14
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri Apr 26 15:23:23 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA