Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT00124735
Status:
COMPLETED
Last Update Posted:
2016-08-24
First Post:
2005-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Determine the Dose Requirements of Rocuronium Bromide (Zemuron®) in Pediatric and Adolescent Subjects (21048)(COMPLETED)(P05797)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077123', 'term': 'Rocuronium'}], 'ancestors': [{'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'Any scientific paper, presentation, or other communication concerning the clinical trial described in the protocol will first be submitted to Organon, at least 6 weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'All subjects who received rocuronium were included in the safety analyses.\n\nInformation regarding adverse events were obtained by questioning or examining the subject. At each visit during the treatment period, all new complaints and symptoms were recorded.', 'eventGroups': [{'id': 'EG000', 'title': 'Rocuronium Bolus Maintenance', 'description': 'Subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation (includes neonates, infants, toddlers, children, and adolescents).', 'otherNumAtRisk': 64, 'otherNumAffected': 10, 'seriousNumAtRisk': 64, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Rocuronium Continuous Infusion Maintenance', 'description': 'Subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation (includes neonates, infants, toddlers, children, and adolescents)', 'otherNumAtRisk': 73, 'otherNumAffected': 9, 'seriousNumAtRisk': 73, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Dose of Zemuron (Rocuronium) Administered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}, {'value': '19', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Rocuronium Bolus Maintenance - Neonate (BN)', 'description': 'Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'OG001', 'title': 'Rocuronium Bolus Maintenance - Infants (BI)', 'description': 'Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'OG002', 'title': 'Rocuronium Bolus Maintenance - Toddlers (BT)', 'description': 'Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'OG003', 'title': 'Rocuronium Bolus Maintenance -Children (BC)', 'description': 'Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'OG004', 'title': 'Rocuronium Bolus Maintenance - Adolescents (BA)', 'description': 'Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'OG005', 'title': 'Rocuronium Continuous Infusion Maintenance - Neonates (IN)', 'description': 'Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}, {'id': 'OG006', 'title': 'Rocuronium Continuous Infusion Maintenance - Infants (II)', 'description': 'Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}, {'id': 'OG007', 'title': 'Rocuronium Continuous Infusion Maintenance - Toddlers (IT)', 'description': 'Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}, {'id': 'OG008', 'title': 'Rocuronium Continuous Infusion Maintenance - Children (IC)', 'description': 'Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}, {'id': 'OG009', 'title': 'Rocuronium Continuous Infusion Maintenance - Adolescents (IA)', 'description': 'Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}], 'classes': [{'categories': [{'measurements': [{'value': '0.91', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '0.86', 'spread': '0.18', 'groupId': 'OG002'}, {'value': '0.81', 'spread': '0.10', 'groupId': 'OG003'}, {'value': '0.96', 'spread': '0.16', 'groupId': 'OG004'}, {'value': '1.01', 'spread': '0.37', 'groupId': 'OG005'}, {'value': '0.84', 'spread': '0.15', 'groupId': 'OG006'}, {'value': '1.00', 'spread': '0.25', 'groupId': 'OG007'}, {'value': '1.26', 'spread': '0.78', 'groupId': 'OG008'}, {'value': '0.99', 'spread': '0.37', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during surgery', 'description': 'Total dose from administration of intubating dose to reappearance of T3 (the third twitch of a Train of Four \\[TOF\\] stimulation) after the last maintenance bolus dose or discontinuation of Zemuron (rocuronium) infusion (Per protocol \\[PP\\] data set)', 'unitOfMeasure': 'mg/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population'}, {'type': 'SECONDARY', 'title': 'Duration of Recovery of T4/T1 Ratio (TOF Fourth Twitch to First Twitch) 70%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Rocuronium Bolus Maintenance - Neonate (BN)', 'description': 'Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'OG001', 'title': 'Rocuronium Bolus Maintenance - Infants (BI)', 'description': 'Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'OG002', 'title': 'Rocuronium Bolus Maintenance - Toddlers (BT)', 'description': 'Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'OG003', 'title': 'Rocuronium Bolus Maintenance -Children (BC)', 'description': 'Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'OG004', 'title': 'Rocuronium Bolus Maintenance - Adolescents (BA)', 'description': 'Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'OG005', 'title': 'Rocuronium Continuous Infusion Maintenance - Neonates (IN)', 'description': 'Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}, {'id': 'OG006', 'title': 'Rocuronium Continuous Infusion Maintenance - Infants (II)', 'description': 'Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}, {'id': 'OG007', 'title': 'Rocuronium Continuous Infusion Maintenance - Toddlers (IT)', 'description': 'Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}, {'id': 'OG008', 'title': 'Rocuronium Continuous Infusion Maintenance - Children (IC)', 'description': 'Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}, {'id': 'OG009', 'title': 'Rocuronium Continuous Infusion Maintenance - Adolescents (IA)', 'description': 'Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}], 'classes': [{'categories': [{'measurements': [{'value': '29.62', 'spread': '13.60', 'groupId': 'OG000'}, {'value': '33.25', 'spread': '16.17', 'groupId': 'OG001'}, {'value': '22.65', 'spread': '7.62', 'groupId': 'OG002'}, {'value': '16.19', 'spread': '6.70', 'groupId': 'OG003'}, {'value': '28.04', 'spread': '13.33', 'groupId': 'OG004'}, {'value': '43.32', 'spread': '1.53', 'groupId': 'OG005'}, {'value': '33.25', 'spread': '0.00', 'groupId': 'OG006'}, {'value': '23.08', 'spread': '13.40', 'groupId': 'OG007'}, {'value': '18.37', 'spread': '12.69', 'groupId': 'OG008'}, {'value': '27.59', 'spread': '12.51', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)', 'description': 'The time it takes for the the T4 to T1 ratio to reach 70%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per-protocol population'}, {'type': 'SECONDARY', 'title': 'Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 80%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Rocuronium Bolus Maintenance - Neonate (BN)', 'description': 'Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'OG001', 'title': 'Rocuronium Bolus Maintenance - Infants (BI)', 'description': 'Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'OG002', 'title': 'Rocuronium Bolus Maintenance - Toddlers (BT)', 'description': 'Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'OG003', 'title': 'Rocuronium Bolus Maintenance -Children (BC)', 'description': 'Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'OG004', 'title': 'Rocuronium Bolus Maintenance - Adolescents (BA)', 'description': 'Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'OG005', 'title': 'Rocuronium Continuous Infusion Maintenance - Neonates (IN)', 'description': 'Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}, {'id': 'OG006', 'title': 'Rocuronium Continuous Infusion Maintenance - Infants (II)', 'description': 'Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}, {'id': 'OG007', 'title': 'Rocuronium Continuous Infusion Maintenance - Toddlers (IT)', 'description': 'Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}, {'id': 'OG008', 'title': 'Rocuronium Continuous Infusion Maintenance - Children (IC)', 'description': 'Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}, {'id': 'OG009', 'title': 'Rocuronium Continuous Infusion Maintenance - Adolescents (IA)', 'description': 'Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}], 'classes': [{'categories': [{'measurements': [{'value': '36.62', 'spread': '17.14', 'groupId': 'OG000'}, {'value': '43.58', 'spread': '21.47', 'groupId': 'OG001'}, {'value': '32.39', 'spread': '12.84', 'groupId': 'OG002'}, {'value': '20.43', 'spread': '9.79', 'groupId': 'OG003'}, {'value': '35.75', 'spread': '19.43', 'groupId': 'OG004'}, {'value': '57.83', 'spread': '12.33', 'groupId': 'OG005'}, {'value': '44.75', 'spread': '0.00', 'groupId': 'OG006'}, {'value': '29.47', 'spread': '16.65', 'groupId': 'OG007'}, {'value': '21.82', 'spread': '14.57', 'groupId': 'OG008'}, {'value': '35.45', 'spread': '17.02', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)', 'description': 'The time it takes for the the T4 to T1 ratio to reach 80%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per-protocol population'}, {'type': 'SECONDARY', 'title': 'Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 90%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Rocuronium Bolus Maintenance - Neonate (BN)', 'description': 'Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'OG001', 'title': 'Rocuronium Bolus Maintenance - Infants (BI)', 'description': 'Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'OG002', 'title': 'Rocuronium Bolus Maintenance - Toddlers (BT)', 'description': 'Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'OG003', 'title': 'Rocuronium Bolus Maintenance -Children (BC)', 'description': 'Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'OG004', 'title': 'Rocuronium Bolus Maintenance - Adolescents (BA)', 'description': 'Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'OG005', 'title': 'Rocuronium Continuous Infusion Maintenance - Neonates (IN)', 'description': 'Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}, {'id': 'OG006', 'title': 'Rocuronium Continuous Infusion Maintenance - Infants (II)', 'description': 'Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}, {'id': 'OG007', 'title': 'Rocuronium Continuous Infusion Maintenance - Toddlers (IT)', 'description': 'Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}, {'id': 'OG008', 'title': 'Rocuronium Continuous Infusion Maintenance - Children (IC)', 'description': 'Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}, {'id': 'OG009', 'title': 'Rocuronium Continuous Infusion Maintenance - Adolescents (IA)', 'description': 'Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}], 'classes': [{'categories': [{'measurements': [{'value': '28.25', 'spread': '0', 'groupId': 'OG000'}, {'value': '53.66', 'spread': '14.58', 'groupId': 'OG001'}, {'value': '45.31', 'spread': '18.20', 'groupId': 'OG002'}, {'value': '23.09', 'spread': '10.90', 'groupId': 'OG003'}, {'value': '49.25', 'spread': '31.73', 'groupId': 'OG004'}, {'value': '52.25', 'spread': '0', 'groupId': 'OG005'}, {'value': '50.75', 'spread': '0', 'groupId': 'OG006'}, {'value': '37.86', 'spread': '18.46', 'groupId': 'OG007'}, {'value': '28.02', 'spread': '21.46', 'groupId': 'OG008'}, {'value': '38.68', 'spread': '16.08', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)', 'description': 'The time it takes for the the T4 to T1 ratio to reach 90%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per-protocol population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rocuronium Bolus Maintenance - Neonate (BN)', 'description': 'Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'FG001', 'title': 'Rocuronium Bolus Maintenance - Infants (BI)', 'description': 'Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'FG002', 'title': 'Rocuronium Bolus Maintenance - Toddlers (BT)', 'description': 'Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'FG003', 'title': 'Rocuronium Bolus Maintenance -Children (BC)', 'description': 'Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'FG004', 'title': 'Rocuronium Bolus Maintenance - Adolescents (BA)', 'description': 'Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'FG005', 'title': 'Rocuronium Continuous Infusion Maintenance - Neonates (IN)', 'description': 'Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}, {'id': 'FG006', 'title': 'Rocuronium Continuous Infusion Maintenance - Infants (II)', 'description': 'Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}, {'id': 'FG007', 'title': 'Rocuronium Continuous Infusion Maintenance - Toddlers (IT)', 'description': 'Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}, {'id': 'FG008', 'title': 'Rocuronium Continuous Infusion Maintenance - Children (IC)', 'description': 'Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}, {'id': 'FG009', 'title': 'Rocuronium Continuous Infusion Maintenance - Adolescents (IA)', 'description': 'Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '21'}, {'groupId': 'FG004', 'numSubjects': '19'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '20'}, {'groupId': 'FG008', 'numSubjects': '25'}, {'groupId': 'FG009', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '19'}, {'groupId': 'FG008', 'numSubjects': '22'}, {'groupId': 'FG009', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '19', 'groupId': 'BG007'}, {'value': '23', 'groupId': 'BG008'}, {'value': '20', 'groupId': 'BG009'}, {'value': '137', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': 'Rocuronium Bolus Maintenance - Neonate (BN)', 'description': 'Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'BG001', 'title': 'Rocuronium Bolus Maintenance - Infants (BI)', 'description': 'Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'BG002', 'title': 'Rocuronium Bolus Maintenance - Toddlers (BT)', 'description': 'Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'BG003', 'title': 'Rocuronium Bolus Maintenance -Children (BC)', 'description': 'Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'BG004', 'title': 'Rocuronium Bolus Maintenance - Adolescents (BA)', 'description': 'Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation'}, {'id': 'BG005', 'title': 'Rocuronium Continuous Infusion Maintenance - Neonates (IN)', 'description': 'Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}, {'id': 'BG006', 'title': 'Rocuronium Continuous Infusion Maintenance - Infants (II)', 'description': 'Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}, {'id': 'BG007', 'title': 'Rocuronium Continuous Infusion Maintenance - Toddlers (IT)', 'description': 'Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}, {'id': 'BG008', 'title': 'Rocuronium Continuous Infusion Maintenance - Children (IC)', 'description': 'Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}, {'id': 'BG009', 'title': 'Rocuronium Continuous Infusion Maintenance - Adolescents (IA)', 'description': 'Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '19', 'groupId': 'BG007'}, {'value': '23', 'groupId': 'BG008'}, {'value': '20', 'groupId': 'BG009'}, {'value': '137', 'groupId': 'BG010'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Total of 137 subjects include all subjects who received rocuronium', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '11', 'groupId': 'BG008'}, {'value': '12', 'groupId': 'BG009'}, {'value': '52', 'groupId': 'BG010'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '13', 'groupId': 'BG007'}, {'value': '12', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '85', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Total of 137 subjects include all subjects who received rocuronium', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-14', 'studyFirstSubmitDate': '2005-07-26', 'resultsFirstSubmitDate': '2008-12-05', 'studyFirstSubmitQcDate': '2005-07-26', 'lastUpdatePostDateStruct': {'date': '2016-08-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-03-12', 'studyFirstPostDateStruct': {'date': '2005-07-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Dose of Zemuron (Rocuronium) Administered', 'timeFrame': 'during surgery', 'description': 'Total dose from administration of intubating dose to reappearance of T3 (the third twitch of a Train of Four \\[TOF\\] stimulation) after the last maintenance bolus dose or discontinuation of Zemuron (rocuronium) infusion (Per protocol \\[PP\\] data set)'}], 'secondaryOutcomes': [{'measure': 'Duration of Recovery of T4/T1 Ratio (TOF Fourth Twitch to First Twitch) 70%', 'timeFrame': 'after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)', 'description': 'The time it takes for the the T4 to T1 ratio to reach 70%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).'}, {'measure': 'Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 80%', 'timeFrame': 'after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)', 'description': 'The time it takes for the the T4 to T1 ratio to reach 80%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).'}, {'measure': 'Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 90%', 'timeFrame': 'after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)', 'description': 'The time it takes for the the T4 to T1 ratio to reach 90%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Bhattacharya ST, Jeffrey Koh J, Martin L, Suresh S, Frietsch T. Randomized, Multicenter Trial of Rocuronium in Neonates, Infants, Toddlers, Children & Adolescents [abstract]. Anesthesiology. 2009;111(5):A841.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to determine the dose requirements of rocuronium bromide when administered as a bolus dose (a single, large dose) for intubation (insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation) and when administered by either continuous infusion or bolus doses for maintenance of muscle relaxation in term neonates (birth to \\<28 days old), infants (28 days to \\<=3 months) and toddlers (\\>3 months to \\<=2 years), children (2 years to less than or equal to 11 years of age), and adolescents (\\>11 years to less than or equal to 17 years of age).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects from birth up to 17 years of age who are scheduled for surgery with an anticipated duration of anesthesia of about 2 hours or more requiring a maintenance muscle relaxation dose(s).\n\nExclusion Criteria:\n\n* Subjects whose parent(s) or legal guardian(s) are not willing to give written consent and where applicable, subjects who have not given appropriate assent to participate in the trials will not be allowed to enter.'}, 'identificationModule': {'nctId': 'NCT00124735', 'briefTitle': 'A Study to Determine the Dose Requirements of Rocuronium Bromide (Zemuron®) in Pediatric and Adolescent Subjects (21048)(COMPLETED)(P05797)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-label, Randomized, Phase IIIB, Multicenter Trial to Evaluate the Pharmacodynamic Parameters of Intubation Bolus, and Bolus and Infusion Maintenance Doses of Zemuron® in Pediatric and Adolescent Subjects', 'orgStudyIdInfo': {'id': 'P05797'}, 'secondaryIdInfos': [{'id': '21048'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rocuronium bolus maintenance', 'description': 'Rocuronium bolus maintenance', 'interventionNames': ['Drug: Rocuronium bolus maintenance']}, {'type': 'EXPERIMENTAL', 'label': 'Rocuronium continuous infusion maintenance', 'description': 'Rocuronium continuous infusion maintenance', 'interventionNames': ['Drug: rocuronium continuous infusion maintenance']}], 'interventions': [{'name': 'Rocuronium bolus maintenance', 'type': 'DRUG', 'otherNames': ['Zemuron', 'ORG 9426'], 'description': 'Subjects received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation', 'armGroupLabels': ['Rocuronium bolus maintenance']}, {'name': 'rocuronium continuous infusion maintenance', 'type': 'DRUG', 'otherNames': ['Zemuron', 'ORG 9426'], 'description': 'Subjects received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation', 'armGroupLabels': ['Rocuronium continuous infusion maintenance']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}