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    Summary
    EudraCT Number:2013-002164-53
    Sponsor's Protocol Code Number:20130513
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-10-28
    Trial results View 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 ConcernedAustria - BASG
    A.2EudraCT number2013-002164-53
    A.3Full title of the trial
    The reversed isolated forearm technique to regionally reverse rocuronium induced muscle relaxation – a pilot study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A pilot Study to evaluate the feasibility of a new technique (the reversed isolated forearm technique) that enables the reversion of systemic muscle paralysis due to rocuronium only in one forearm.
    A.3.2Name or abbreviated title of the trial where available
    The reversed isolated forearm technique – a pilot study
    A.4.1Sponsor's protocol code number20130513
    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 SponsorMedizinische Universität Wien, Abteilung für Allgemeine Anästhesie und Intensivmedizin
    B.1.3.4CountryAustria
    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 supportMedizinische Universität Wien, Abteilung für Allgemeine Anästhesie und Intensivmedizin
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Wien, Abteilung für Allgemeine Anästhesie und Intensivmedizin
    B.5.2Functional name of contact pointForschungsbüro, Fr. Mag. Vecs
    B.5.3 Address:
    B.5.3.1Street AddressWähringer Gürtel 18-20
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number+431404002031
    B.5.5Fax number+431404004104
    B.5.6E-maileleonora.vecs@meduniwien.ac.at
    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 holderN.V. Organon, Oss, Niederlande
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameSugammadex
    D.3.4Pharmaceutical form 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 INNSUGAMMADEX
    D.3.9.1CAS number 343306-79-6
    D.3.9.3Other descriptive nameSUGAMMADEX SODIUM
    D.3.9.4EV Substance CodeSUB32205
    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.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
    To evaluate the feasibility of regionally reversing a rocuronium induced muscle relaxation and to determine the dose of sugammadex that is necessary to reach a train of four (TOF) ratio ≥ 0.9.
    To determine the time needed to regionally reverse rocuronium induced muscle relaxation to a TOF) ratio ≥ 0.9.
    To determine the effects of systemic muscle relaxation when the tourniquet is released
    E.1.1.1Medical condition in easily understood language
    This trial will investigate the feasibility and dose necessary to reverse muscleparalysis during generalanaesthesia due to rocuronium but only regionally in one exsanguined arm of the patient.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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 evaluate the feasibility of regionally reversing a rocuronium induced muscle relaxation and to determine the dose of sugammadex that is necessary to reach a train of four (TOF) ratio ≥ 0.9.
    E.2.2Secondary objectives of the trial
    To determine the time needed to regionally reverse rocuronium induced muscle relaxation to a TOF) ratio ≥ 0.9.

    To determine the effects of systemic muscle relaxation when the tourniquet is released
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    We will include only adult (age 18-80 years) ASA 1-3 patients of an BMI between 18 and 30 that undergo elective surgery with the need of general anaesthesia and who will receive routine muscle relaxation with rocuronium. We will only include patients that undergo procedures that provide access to both arms to simultaneously measure the TOF.
    E.4Principal exclusion criteria
    We will exclude patients with a known allergy against sugammadex as well as patients with severe renal impairment since sugammadex is contraindicated or not recommended in these patients. Patients in whom pregnancy cannot be excluded will be excluded.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint of the first sequence is the mean dose necessary to regionally reverse the rocuronium induced muscle relaxation to a TOF level ≥ 0.9.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After completion of sequence 1 according to the study protocol
    E.5.2Secondary end point(s)
    Secondary outcome parameter is the effect of the release of the tourniquet on the systemic muscle relaxation, as represented by the TOF of the not exsanguined arm.
    Primary endpoint of the second sequence is the time needed to provide a regional reversal of the rocuronium induced muscle relaxation to a TOF level ≥ 0.9 with the mean dose calculated at sequence one.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After completion of sequence one and two according to the study protocol
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 Yes
    E.8.1.7.1Other trial design description
    This trial is a prospective, sequential, interventional, single centre pilot study. Phase 2.
    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.8.3 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.8.5The 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    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: 20
    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 state20
    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 Decision2013-12-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-24
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