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Rocuronium bromide

Phase 3

Anesthesia | Small molecule | Pain |Merck & Company, Inc.|Last Updated: Jun 1, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials2
Total Enrollment245

FDA Designations

No designations recorded

Clinical trial landscape

Rocuronium bromide · 3 trials · 2 indications

Phase 3 3
NCT00124722A Study to Compare Different Intubating Doses of Zemuron in Pediatric and Adolescent Subjects Under General AnesthesiaAnesthesia
COMPLETED207 Analytics
NCT00984633Study of Efficacy, Pharmacokinetics, and Safety of Bolus Maintenance Doses of Org 9426 (Study P05976)(COMPLETED)Muscle Relaxation
COMPLETED40 Analytics
NCT00988520Study of Efficacy, Pharmacokinetics and Safety of Continuous Intravenous Infusion of Org 9426 (Study P05977)Anesthesia
COMPLETED38 Analytics
PHASE3COMPLETED
A Study to Compare Different Intubating Doses of Zemuron in Pediatric and Adolescent Subjects Under General Anesthesia
AnesthesiaUnlock trial analytics
PHASE3COMPLETED
Study of Efficacy, Pharmacokinetics, and Safety of Bolus Maintenance Doses of Org 9426 (Study P05976)(COMPLETED)
Muscle RelaxationUnlock trial analytics
PHASE3COMPLETED
Study of Efficacy, Pharmacokinetics and Safety of Continuous Intravenous Infusion of Org 9426 (Study P05977)
AnesthesiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to reappearance of T3 (time from end-administration of Zemuron to reappearance of the third twitch of a TOF stimulation)
during surgery
Clinical duration of 2 doses of Org 9426 in maintenance of muscle relaxation
Time from intubating dose to bolus maintenance dose
Infusion rate following intubation doses of 0.6 mg/kg or 0.9 mg/kg
90 minutes after start of continuous infusion

Secondary Endpoints

Onset time, maximum block, time to reappearance of T1, Recovery to TOF 0.7, 0.8 and 0.9 and intubation score
during and after surgery
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
0.45 mg/kg ZemuronEXPERIMENTAL0.45 mg/kg Zemuron
0.6 mg/kg ZemuronACTIVE_COMPARATOR0.6 mg/kg Zemuron
1.0 mg/kg ZemuronEXPERIMENTAL1.0 mg/kg Zemuron
0.6 mg/kg intubation dose + sevofluraneEXPERIMENTAL -
0.9 mg/kg intubation dose + sevofluraneEXPERIMENTAL -
0.6 mg/kg intubation dose + propofolEXPERIMENTAL -
0.9 mg/kg intubation dose + propofolEXPERIMENTAL -
0.6 mg/kg intubation dose under sevofluraneEXPERIMENTAL -
0.9 mg/kg intubation dose under sevofluraneEXPERIMENTAL -
continuous dose following 0.6 mg/kg intubation dose + propofolEXPERIMENTAL -
continuous dose following 0.9 mg/kg intubation dose + propofolEXPERIMENTAL -

Interventions

NameTypeDescription
Rocuronium bromide (Zemuron)DRUGA single IV Zemuron bolus dose of 0.45 mg/kg prior to intubation.
Rocuronium bromide (Org 9426)DRUG0.6 mg/kg injection intubation dose
SevofluraneDRUG0.5-2.0% intravenous maintenance anesthesia
PropofolDRUG4-10 mg/kg/hr maintenance anesthesia
Rocuronium bromideDRUGContinuous intravenous infusion initiated at 7 μg/kg/min and adjusted to maintain muscle relaxation
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Eligibility Criteria

Age RangeN/A to 17 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Male and female subjects from birth up to 17 years of age who will be scheduled for surgery under general anesthesia. Exclusion Criteria: * Subjects whose parent(s) or legal guardian(s) are not willing to give written consent and where applicable, subjects who have not given...

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Competitive Landscape -Anesthesia and Sedation 4 trials (matched to "Anesthesia")

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Frequently asked questions about Rocuronium bromide

What is Rocuronium bromide used for?

Rocuronium bromide is used for anesthesia and muscle relaxation. It is a small molecule being developed by Merck & Company, Inc. (MRK) and is currently in Phase 3 clinical development. The drug is intended to provide muscle relaxation during surgical procedures under general anesthesia.

What does Rocuronium bromide target?

Rocuronium bromide is a neuromuscular blocking agent that works by blocking the action of acetylcholine at the neuromuscular junction, leading to muscle relaxation. It is used to facilitate endotracheal intubation and provide skeletal muscle relaxation during surgery or mechanical ventilation.

Who makes Rocuronium bromide?

Rocuronium bromide is developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 3 clinical development for use in anesthesia and muscle relaxation.

What phase is Rocuronium bromide in?

Rocuronium bromide is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is being studied for its efficacy and safety in providing muscle relaxation during anesthesia.

What clinical trials is Rocuronium bromide in?

Rocuronium bromide has completed three Phase 3 clinical trials. These include NCT00124722, which compared different intubating doses in pediatric and adolescent subjects under general anesthesia with 207 participants, and NCT00984633 and NCT00988520, which studied bolus maintenance doses and continuous intravenous infusion, respectively, with 40 and 38 participants.

Is Rocuronium bromide the same as Zemuron?

Yes, Rocuronium bromide is also known as Zemuron. The clinical trial NCT00124722, which studied different intubating doses of the drug in pediatric and adolescent subjects, refers to Zemuron in its title. This alternative name is used in some clinical and commercial contexts.