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CLINICAL TRIALS PROFILE FOR ZEMURON

Clinical Trials for Zemuron

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00124722	A Study to Compare Different Intubating Doses of Zemuron in Pediatric and Adolescent Subjects Under General Anesthesia	Completed	Merck Sharp & Dohme Corp.	Phase 3	The primary purpose of this study is to evaluate the time course of muscle relaxation after administration of three different single intravenous bolus doses of rocuronium bromide for intubation (insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation) 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). Subjects in each of the age groups will be randomized to one of 3 Zemuron® doses: 0.45 mg/kg, 0.6 mg/kg, or 1.0 mg/kg.
NCT00124735	A Study to Determine the Dose Requirements of Rocuronium Bromide (Zemuron®) in Pediatric and Adolescent Subjects (21048)(COMPLETED)(P05797)	Completed	Merck Sharp & Dohme Corp.	Phase 3	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).
NCT00474253	Comparison of Recovery From Rocuronium 1.2 mg/kg Followed By Org 25969 16 mg/kg at 3 Minutes With Recovery From Succinylcholine 1.0 mg/kg (19.4.303)(P05946)	Completed	Merck Sharp & Dohme Corp.	Phase 3	The purpose of the trial is to demonstrate a faster recovery from neuromuscular block induced by 1.2 mg/kg Zemuron® after reversal at 3 minutes by 16.0 mg/kg of Org 25969 compared with recovery after a neuromuscular block induced by 1.0 mg/kg succinylcholine.
NCT00475215	Evaluation of Safety and Efficacy of Org 25969 in Subjects With or Having a Past History of Pulmonary Disease (19.4.308)(P05932)	Completed	Merck Sharp & Dohme Corp.	Phase 3	The purpose of the trial is to research the safety and to show faster recovery after administration of 2.0 mg/kg or 4.0 mg/kg Org 25969 (sugammadex) given as a reversal agent for Zemuron® in subjects diagnosed with or having a history of pulmonary disease.
NCT00535743	Dose-Finding Trial With Sugammadex at 3 and 15 Minutes After 1.0 and 1.2 mg/kg Rocuronium Bromide in Subjects of ASA Class 1-3 (19.4.206)(P05944)	Completed	Merck Sharp & Dohme Corp.	Phase 2	The objective of the trial was to explore the dose-response relation of Org 25969 given as a reversal agent at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® (rocuronium) in subjects of ASA 1 to 3, and to evaluate the safety of single doses of Org 25969 administered to subjects of ASA 1 to 3.
Trial ID	Title	Status	Sponsor	Phase	Summary