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    Summary
    EudraCT Number:2013-001965-17
    Sponsor's Protocol Code Number:AITT2013/5
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-08-06
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2013-001965-17
    A.3Full title of the trial
    Incidence of postoperative residual neuromuscular blockade following the administration of rocuronium: A randomized placebo controlled study.
    Posztoperatív reziduális neuromuszkuláris blokád előfordulásának vizsgálata rocuroniummal végzett izomrelaxációt követően: Randomizált, placebo kontrollos tanulmány.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation on occurence of muscle weakness after surgeries
    Műtét utáni izomgyengeség előfordulásának vizsgálata
    A.4.1Sponsor's protocol code numberAITT2013/5
    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 SponsorDebreceni Egyetem Orvos- és Egészségtudományi Centrum Aneszteziológiai és Intenzív Terápiás Tanszék
    B.1.3.4CountryHungary
    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 supportUniversity of Debrecen, Medical and Health Science Center, Department of Anaesthesiology and Intensive Care
    B.4.2CountryHungary
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Debrecen, Medical and Health Science Center, Department of Anaesthesiology and Intensive Care
    B.5.2Functional name of contact pointDepartmental Office
    B.5.3 Address:
    B.5.3.1Street AddressNagyerdei krt. 98
    B.5.3.2Town/ cityDebrecen
    B.5.3.3Post code4032
    B.5.3.4CountryHungary
    B.5.4Telephone number003652255347
    B.5.5Fax number003652255347
    B.5.6E-mailfulesdi@med.unideb.hu
    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 No
    D.2.1.1.1Trade name Bridion
    D.2.1.1.2Name of the Marketing Authorisation holderN.V. Organon
    D.2.1.2Country which granted the Marketing AuthorisationHungary
    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 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.3.9.3Other descriptive nameSUGAMMADEX
    D.3.9.4EV Substance CodeSUB26695
    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.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Stigmosan
    D.2.1.1.2Name of the Marketing Authorisation holderPharmamagist
    D.2.1.2Country which granted the Marketing AuthorisationHungary
    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 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.3.9.3Other descriptive nameNEOSTIGMINE METHYLSULFATE
    D.3.9.4EV Substance CodeSUB20700
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,5
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The effect of sugammadex and neostigmin on postoperative residual neuromuscular blockade will be investigated, therefore the patients suffering from various conditions undergoing surgery in general anaesthesia with muscle relaxation will be included int he study.sthesia with muscle relaxation will be included in the study.
    a sugammadex és neostigmin hatását vizsgáljuk a postoperativ reziduális neuromuscularis blokád előfordulására izomrelaxálást igénylő sebészeti betegeken
    E.1.1.1Medical condition in easily understood language
    The effect of two drugs (sugammadex and neostigmin) on muscle weakness will be investigated after surgeries
    Két gyógyszer (sugammadex és neostigmin) hatását vizsgáljuk műtét utáni izomgyengeség szempontjából
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    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
    The main objective of the trial is to determine the incidence of postoperative residual neuromuscular blockade on arrival to the postanaesthesia care unit after spontaneous recovery from neuromuscular blockade or reversal with sugammadex or neostigmin
    A vizsgálat elsődleges végpontja a postoperativ reziduális neuromuscularis blokád előfordulásának meghatározása a postoperativ őrzőbe történő érkezéskor, miután a műtőben az izomrelaxáns hatást felfüggesztették sugammadex vagy neostigmin segítségével, vagy spontán visszatérést engedtek
    E.2.2Secondary objectives of the trial
    The secondary objective of the trial is to determine the incendence of recurrent postoperative residual neuromuscular blockade at 20, 40 and 60 minutes after arrival to the postanaesthesia care unit following spontaneous recovery from neuromuscular blockade or reversal with sugammadex or neostgmin
    A vizsgálat másodlagos végpontja a visszatérő reziduális neuromuscularis blokád előfodulásának meghatározása a postoperativ őrzőbe történő érkezést követő 20., 40. és 60. percben, miután az izomrelaxánst a műtőben felfüggesztették sugammadex vagy neostigmin segítségével vagy spontán visszatérést követően
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    signed written informed consent sheet
    - age 18-65 years
    - ASA I-III (American Society of Anesthesiologists physical score)
    - BMI 18,5-25 (normal body weight)
    - expected opration time at least 50 minutes
    - operation requiring intratracheal intubation
    - patient in supine position and one arm is accessible
    - Életkor 18-65 év
    - ASA I-III (American Society of Anesthesiologists physical score)
    - BMI 18,5-25 (normál testtömeg)
    - műtét várható időtartama legalább 50 perc
    - intratracheális intubációt igénylő műtéti eljárás
    - háton fekvő testhelyzetben van a beteg és egyik karja hozzáférhető
    E.4Principal exclusion criteria
    - diseases affecting neuromuscular transmission (myasthenia, myopathy, stroke, severe hepatic or renal insufficiency)
    - medications affecting neuromuscular transmission (aminoglycoside antibiotics, magnesium)
    - difficult airway, difficult intubation expected
    - gravidity
    - lactation- acute surgery
    - COPD
    - glaucoma
    - patient participated in an other trial within one month
    - neuromuszkuláris funkciót befolyásoló betegség (myopathia, súlyos máj- és veseelégtelenség, myasthenia, stroke)
    - neuromuszkuláris funkciót befolyásoló gyógyszerek (aminoglikozidok, magnézium)
    - nehéz légút, várható nehéz intubáció
    - terhesség
    - szoptatás
    - akut műtét
    - COPD
    - glaukoma
    - egy hónapon belül más tanulmányban vett részt
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is to define the incidence of postoerpative residual neuromuscular blockade on arrival to the postanaesthesia care unit
    A study elsődleges végpontja a postoperative reziduális neuromuszkuláris blokád előfordulásának meghatározása a postoperativ őrzőbe történő érkezéskor
    E.5.1.1Timepoint(s) of evaluation of this end point
    On arrival to the postanaesthesia care unit (T0)
    A postoperativ őrzőbe történő érkezéskor (T0)
    E.5.2Secondary end point(s)
    The secondary endpoint of the study is to determine the incidence of recurrent postoeprative residual neuromuscular blockade at 20, 40 and minutes after arrival to the postanaesthesia care unit
    A vizsgálat másodlagos végpontja a visszatérő postoperativ reziduális neuromuszkuláris blokád előfordulásának meghatározása a postoperativ őrzőbe történő érkezést követő 20., 40. és 60. percben
    E.5.2.1Timepoint(s) of evaluation of this end point
    20, 40, 60 minutes after arrival to the postanaesthesia care unit (T20, T40, T60)
    A postoperativ őrzőbe történő érkezést követő 20., 40. és 60. perc (T20, T40, T60)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 Yes
    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 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 trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number 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 EEA1
    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 months12
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 90
    F.1.3Elderly (>=65 years) 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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    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 Decision2013-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-17
    P. End of Trial
    P.End of Trial StatusOngoing
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