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Rocuronium /kg intubating dose

Phase 3

Anesthesia | Small molecule | Pain |Merck & Company, Inc.|Last Updated: Apr 17, 2015

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
RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment90
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00970762Comparative Study of Rocuronium With Vecuronium (Study 71101)(COMPLETED)PHASE3 COMPLETED 90 — — Feb 1, 2003Feb 1, 2004Apr 17, 2015 - —
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Study Endpoints
Primary Endpoints
Onset time of intubating dose. DESCRIPTION: The time interval between the completion of injection of the study drug (rocuronium or vecuronium) and the maximal depression of first twitch--measured via TOF Watch Sx(R)-- was defined as the onset time.
Day of Surgery, after injection of study drug until maximal depression of first twitch achieved
Secondary Endpoints
Number of subjects who achieved maximal block >=90% after the intubating dose. DESCRIPTION: Reaching a 90% depression of first twitch--measured via TOF Watch Sx(R)--was defined as achieving 90% block
Day of Surgery, after injection of study drug until maximal depression of first twice achieved
Clinical duration after first maintenance dose. DESCRIPTION: The time interval between the completion of injection of study drug and return of first twitch to 25%(as measured by TOF Watch Sx(R)) was defined as the clinical duration.
Day of Surgery, after injection of study drug until return of first twitch to 25%
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Rocuronium 0.6 INT, 0.1 MNTEXPERIMENTALParticipants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.1 mg/kg maintenance dose of rocuronium.
Rocuronium 0.6 INT, 0.15 MNTEXPERIMENTALParticipants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.15 mg/kg maintenance dose of rocuronium.
Rocuronium 0.6 INT, 0.2 MNTEXPERIMENTALParticipants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.2 mg/kg maintenance dose of rocuronium.
Rocuronium 0.9 INT, 0.1 MNTEXPERIMENTALParticipants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.1 mg/kg maintenance dose of rocuronium.
Rocuronium 0.9 INT, 0.15 MNTEXPERIMENTALParticipants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.15 mg/kg maintenance dose of rocuronium.
Rocuronium 0.9 INT, 0.2 MNTEXPERIMENTALParticipants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.2 mg/kg maintenance dose of rocuronium.
Vecuronium 0.1 INT, 0.025 MNTACTIVE_COMPARATORParticipants in this group received a 0.1 mg/kg intubating dose of vecuronium followed by 0.025 mg/kg maintenance dose of vecuronium.
Interventions
NameTypeDescription
Rocuronium 0.6 mg/kg intubating doseDRUGRocuronium 0.6 mg/kg intubating dose
Rocuronium 0.9 mg/kg intubating doseDRUG0.9 mg/kg intubating dose of rocuronium
Rocuronium 0.1 mg/kg maintenance doseDRUGRocuronium 0.1 mg/kg maintenance dose following the intubating dose.
Rocuronium 0.15 mg/kg maintenance doseDRUGRocuronium 0.15 mg/kg maintenance dose following the intubating dose
Rocuronium 0.2 mg/kg maintenanceDRUGRocuronium 0.2 mg/kg maintenance dose following the intubating dose
Vecuronium 0.1 mg/kg intubating doseDRUGVecuronium 0.1 mg/kg intubating dose
Vecuronium 0.025 mg/kg maintenance doseDRUGVecuronium 0.025 mg/kg maintenance dose following the intubating dose
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Eligibility Criteria
Age Range20 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion criteria: * at least 20 but under 65 years of age * American Society of Anesthesiologists (ASA) Class 1, 2 or 3 for general elective surgery * not considered to be pregnant * scheduled for elective surgery under sevoflurane or propofol anesthesia with an anticipated duration of about 1.5-...

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Competitive Landscape -Anesthesia and Sedation 4 trials
CompanyTickerTrialsLead PhaseDrugs
Masimo CorporationMASI1PHASE1Diprivan , Astra-Zeneca
Cardinal Health, Inc.CAH1 — Undisclosed
Medtronic PlcMDT1NAUndisclosed
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