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Rocuronium bolus maintenance

Phase 3

Anesthesia | Small molecule | Pain |Merck & Company, Inc.|Last Updated: Aug 24, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment149
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00124735A Study to Determine the Dose Requirements of Rocuronium Bromide (Zemuron®) in Pediatric and Adolescent Subjects (21048)(COMPLETED)(P05797)PHASE3 COMPLETED 149Oct 1, 2004Sep 1, 2007Aug 24, 2016 -
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Study Endpoints
Primary Endpoints
Total Dose of Zemuron (Rocuronium) Administered
during surgery

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)

Secondary Endpoints
Duration of Recovery of T4/T1 Ratio (TOF Fourth Twitch to First Twitch) 70%
after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)
Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 80%
after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)
Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 90%
after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Rocuronium bolus maintenanceEXPERIMENTALRocuronium bolus maintenance
Rocuronium continuous infusion maintenanceEXPERIMENTALRocuronium continuous infusion maintenance
Interventions
NameTypeDescription
Rocuronium bolus maintenanceDRUGSubjects received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
rocuronium continuous infusion maintenanceDRUGSubjects received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
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Eligibility Criteria
Age RangeN/A — 17 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * 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). Exclusion Criteria: * Subjects whose parent(s) or legal guardian(s) ...

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