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    Summary
    EudraCT Number:2005-002928-34
    Sponsor's Protocol Code Number:021049
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-03-05
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2005-002928-34
    A.3Full title of the trial
    A randomized, assessor-blind, dose-ranging, phase IIIB, multicenter trial comparing the intubating conditions and time course of block of three different intubating doses (0.45 mg/kg, 0.6 mg/kg, and 1.0 mg/kg) of Zemuron® in pediatric and adolescent subjects under general anesthesia.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Compare Different Intubating Doses of Zemuron in Pediatric and Adolescent Subjects Under General Anesthesia
    A.4.1Sponsor's protocol code number021049
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00124722
    A.5.4Other Identifiers
    Name:Merck Protocol NumberNumber:MK-8085-002
    Name:Schering-Plough Protocol NumberNumber:P05798
    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 SponsorOrganon
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportOrganon
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationN.V. Organon
    B.5.2Functional name of contact pointWilliam Joseph Herring
    B.5.3 Address:
    B.5.3.1Street AddressPO box 20
    B.5.3.2Town/ city BH Oss
    B.5.3.3Post code5340
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+12673057933
    B.5.6E-mailwilliam_herring@merck.com
    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 Esmeron
    D.2.1.1.2Name of the Marketing Authorisation holderNV Organon
    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 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 INNROCURONIUM BROMIDE
    D.3.9.3Other descriptive nameROCURONIUM BROMIDE
    D.3.9.4EV Substance CodeSUB10353MIG
    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.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
    anesthesia
    E.1.1.1Medical condition in easily understood language
    anesthesia
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10018061
    E.1.2Term General anesthesia
    E.1.2System Organ Class 100000004865
    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 time interval between the end of administration of the Zemuron® intubating dose and the reappearance of T3 following one of three intubating doses of Zemuron® (0.45 mg/kg, 0.6 mg/kg, or 1.0 mg/kg) in term neonates (birth to <28 days old), infants (28 days to ≤3 months), toddlers (>3 months to ≤2 years old), children (>2 to ≤11 years of age), and adolescents (>11 to ≤17 years of age).
    E.2.2Secondary objectives of the trial
    1. To evaluate the time course of action (onset time, maximum block, reappearance of T1, and recovery to 70%, 80% and 90% T4/T1) following one of three intubating doses of Zemuron® (0.45 mg/kg, 0.6 mg/kg or 1.0 mg/kg) in term neonates, infants, toddlers, children, and adolescent subjects.
    2. To evaluate the intubating conditions following one of three intubating doses of Zemuron® (0.45 mg/kg 0.6 mg/kg, or 1.0 mg/kg) in term neonates, infants, toddlers, children, and adolescent subjects.
    3. To collect sparse samples for population pharmacokinetic analysis.
    4. To evaluate safety data of three different intubating doses of Zemuron® (0.45 mg/kg, 0.6 mg/kg or 1.0 mg/kg).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Males or non-pregnant, non-nursing females from birth to ≤17 years of age, and of ASA Class 1, 2 or 3 scheduled for surgery under general anesthesia.
    E.4Principal exclusion criteria
    Subjects were to be excluded if they were >17 years of age or preterm neonates (<37 weeks gestational age at birth); had congenital anomalies or airway obstructions that would have precluded visualization or intubation of the trachea; had known significant renal or hepatic disorders; had known or suspected of having neuromuscular disorder, personal or family history of malignant hyperthermia, allergy to narcotic analgesics, hypnotics, NMBAs or other medications used during general anesthesia; were receiving medications during the pre-trial period or were to be receiving medications during the in-trial period in a dosage known to modify the action of NMBAs; required the use of pneumatic tourniquet during the surgical procedure; participated as research subjects in another clinical trial not pre-approved by Organon within 30 days before this trial; had already participated in this trial; or if their parent(s) or legal guardian(s) were not willing to give written consent and where applicable, the subject had not given appropriate assent to participate.
    E.5 End points
    E.5.1Primary end point(s)
    Time to reappearance of T3 (time from end-administration of Zemuron to reappearance of the third twitch of a TOF stimulation)
    E.5.1.1Timepoint(s) of evaluation of this end point
    during surgery
    E.5.2Secondary end point(s)
    Onset time, maximum block, time to reappearance of T1, Recovery to TOF 0.7, 0.8 and 0.9 and intubation score
    E.5.2.1Timepoint(s) of evaluation of this end point
    during and after surgery
    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 Yes
    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) 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 Yes
    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
    different doses of Esmeron
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    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.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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: 207
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 18
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 77
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 55
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 57
    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 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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 207
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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