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   43865   clinical trials with a EudraCT protocol, of which   7286   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:2014-005052-25
    Sponsor's Protocol Code Number:AOP00101
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-05-18
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-005052-25
    A.3Full title of the trial
    Total versus corrected body weight for dosage of sugammadex in morbidly
    obese patients.
    Peso corporeo corretto versus peso corporeo totale per il dosaggio del
    sugammadex in pazienti con obesità patologica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of sugammadex dosed according to total (TBW) and corrected
    body weight (CBW) for reversal of rocuronium-induced neuromuscular
    blockade in morbidly obese patients undergoing laparoscopic bariatric
    surgery. A double-blind, randomized controlled trial.
    Confronto tra sugammadex dosato secondo il peso corporeo totale (TBW)
    e corretto (CBW) nel recupero dal blocco neuromuscolare indotto da
    rocuronio in pazienti sottoposti a chirurgia bariatrica per via
    laparoscopica.
    Studio spontaneo, randomizzato, in doppio cieco
    A.4.1Sponsor's protocol code numberAOP00101
    A.5.4Other Identifiers
    Name:COVERTONumber:COVERTO
    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 SponsorAZIENDA OSPEDALIERA DI PADOVA
    B.1.3.4CountryItaly
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliera di Padova
    B.5.2Functional name of contact pointNucleo per la Ricerca Clinica
    B.5.3 Address:
    B.5.3.1Street AddressVia Giustiniani, 1
    B.5.3.2Town/ cityPadova
    B.5.3.3Post code35128
    B.5.3.4CountryItaly
    B.5.4Telephone number0498214439
    B.5.5Fax number0498217490
    B.5.6E-mailucleoricercaclinica@sanita.padova.it
    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 Bridion
    D.2.1.1.2Name of the Marketing Authorisation holderMSD Italia S.r.l.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Reversal of rocuronium-induced neuromuscular blockade
    Reversal del blocco neuromuscolare indotto da rocuronio
    E.1.1.1Medical condition in easily understood language
    reversal od neuromuscular blockade induced by administration of neuromuscular blocking agents
    Antagonismo farmacologico con recupero del blocco neuromuscolare
    E.1.1.2Therapeutic area Health Care [N] - Health Services Administration [N04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10057286
    E.1.2Term Neuromuscular blockade reversal
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparison of the recovery time from neuromuscular blockade after
    administration of sugammadex dosed on the basis of total body weight
    or corrected body weight in morbidly obese patients
    onfronto tra il tempo di recupero dal blocco neuromuscolare dopo
    somministrazione di sugammadex dosato sulla base del peso totale del
    corpo o del peso corporeo corretto in pazienti morboso obesi
    E.2.2Secondary objectives of the trial
    Comparison of complete recovery of TOF ratio ≧1 between morbidly
    obese patients receiving sugammadex dosed on the basis of total body
    weight or corrected body weight.
    Confronto del recupero completo del TOF ratio≧ 1 tra i pazienti con
    obesità patologica trattati con sugammadex somministrato sulla base del
    peso corporeo totale o peso corporeo corretto.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    age over 18 years;
    • morbid obesity class II (with comorbidities), and class III;
    • patients undergoing surgery for laparoscopic bariatric surgery
    • presence of neuromuscular monitoring (TOF Watch SX®)
    • presence of moderate NMB (T1-T2 TOF) or deep NMB (absence of T1 TOF) at reversal
    • preoperative coagulation parameters within normal limits
    età superiore ai 18 anni;
    • obesità patologica di classe II (con comorbidità) e classe III;
    • pazienti candidati a intervento di chirurgia bariatica per via laparoscopica
    • presenza di monitoraggio neuromuscolare (TOF Watch SX®)
    • presenza di NMB moderato (T1-T2 al TOF) o profondo (assenza di T1 al TOF) al momento del reversal
    • parametri emocoagulativi preoperatori nei limiti di norma
    E.4Principal exclusion criteria
    • obesity class I and II (in the absence of co-morbidities);
    • muscle dysfunction (eg. Myasthenia gravis, muscular dystrophy)
    • cardiac disease (eg. prolong QTc syndrome) and / or cardiac ischemia
    • renal failure
    • liver failure
    • allergic reaction to the drugs used in the study
    • treatment with oral contraceptives, toremifene, flucloxacillin and fusidic acid
    • known or suspected pregnancy
    • anticoagulants treatment
    • hereditary deficiencies of vitamin K dependent coagulation factors
    • patients with pre-existing coagulopathy
    • obesità di classe I e II (in assenza di comorbidità);
    • disfunzioni muscolari (es. miastenia gravis, distrofia muscolare)
    • patologia cardiaca (es. sindrome del QTc lungo) e/o ischemia cardiaca recente
    • insufficienza renale
    • insufficienza epatica
    • reazione allergica ai farmaci utilizzati nello studio
    • trattamento con contraccettivi orali, toremifene, flucloxacillina e acido fusidico
    • gravidanza nota o presunta
    • trattamenti anticoagulativi
    • carenze ereditarie di fattori della coagulazione vitamina K dipendenti
    • pazienti con pre-esistenti coagulopatie
    E.5 End points
    E.5.1Primary end point(s)
    Difference in the time required for complete recovery (TOF ratio ≥1) from moderate or profound neuromuscular block after administration of sugammadex (TBW group vs. group CBW) during recovery from general anesthesia at the end of the surgical procedure.
    Viene considerata la differenza nel tempo necessario per il completo recupero (TOF ratio ≥1) dal blocco neuromuscolare moderato o profondo dopo somministrazione di sugammadex (gruppo TBW vs. gruppo CBW) nella fase di risveglio dall'anestesia generale alla fine della procedura chirurgica.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the surgical procedure
    Alla fine dell'intervento chirurgico
    E.5.2Secondary end point(s)
    Difference in the time required to obtain a normalized TOF ratio (TOF ratio post-reversal / TOF ratio baseline) ≥1 after administration of sugammadex (TBW group vs. group CBW). Adverse effects
    Vengono considerate eventuali differenze nei tempi necessari per ottenere un TOFR normalizzato (TOFR post-reversal/TOFR baseline) ≥1 dopo somministrazione di sugammadex (gruppo TBW vs. gruppo CBW). Si considerano eventuali effetti indesiderati
    E.5.2.1Timepoint(s) of evaluation of this end point
    Until hospital discharge
    Fino a dimissione dall'ospedale
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 Yes
    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 No
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA0
    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
    After completion of enrollment of total subjects
    Dopo completamento dell'arruolamento di tutti i pazienti
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days73
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months24
    E.8.9.2In all countries concerned by the trial days73
    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: 204
    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 state204
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 204
    F.4.2.2In the whole clinical trial 204
    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)
    FOLLOW UP of patient until discharge from the hospital
    FOLLOW UP DEL SOGGETTO FINO ALLA DIMISSIONE DALL'OSPEDALE
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-29
    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-Sat Apr 27 00:09:53 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA