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Vecuronium

Phase 3

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

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Clinical trial landscape

Vecuronium · 1 trial · 1 indication

Phase 3 1
NCT00970762Comparative Study of Rocuronium With Vecuronium (Study 71101)(COMPLETED)Anesthesia
COMPLETED90 Analytics
PHASE3COMPLETED
Comparative Study of Rocuronium With Vecuronium (Study 71101)(COMPLETED)
AnesthesiaUnlock trial analytics

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 to 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 (matched to "Anesthesia")

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