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Study of Efficacy, Pharmacokinetics, and Safety of Bolus Maintenance Doses of Org 9426 (Study P05976)(COMPLETED)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Muscle Relaxation

Intervention: Rocuronium bromide (Org 9426) (Drug); Rocuronium bromide (Org 9426) (Drug); Sevoflurane (Drug); Propofol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.


The purpose of this study is to evaluate the efficacy, pharmacokinetics, and safety of Org 9426 in maintenance of muscle relaxation in adult subjects undergoing general elective surgery.

Clinical Details

Official title: Study of Efficacy, Pharmacokinetics, and Safety of Bolus Maintenance Doses of Org 9426 Following a Single Intubating Dose in Adult Subjects Undergoing Operation Under Sevoflurane or Propofol Anesthesia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Clinical duration of 2 doses of Org 9426 in maintenance of muscle relaxation


Minimum age: 20 Years. Maximum age: 64 Years. Gender(s): Both.


Inclusion Criteria:

- Subjects at least 20 but under 65 years of age.

- Subjects of asa class 1, 2 or 3 for general elective surgery.

- Subjects who are not considered to be pregnant.

- Subjects scheduled for elective surgery under sevoflurane or propofol anesthesia,

with anticipated duration of surgery of about 1. 5-3 hours.

- Subjects with normal laboratory values for serum electrolytes (Na+, K+, Cl-), BUN,

creatinine, total bilirubin, ALP, ALAT and ASAT as judged by the investigator or the sub-investigator.

- Subjects who received an explanation of the trial and agreed informed consent in

writing to participate in the trial in advance. Exclusion Criteria:

- Subjects with renal dysfunction as a complication or in the history.

- Subjects with serum creatinine level greater than 1. 6 mg/dL.

- Subjects with severe hepatic dysfunction as a complication or in the history.

- Subjects with known significant metabolic or neuromuscular disorders.

- Subjects with showing dyspnea, airway obstruction or bronchial asthma.

- Subjects with a history of hypersensitivity to pancuronium bromide, vecuronium

bromide or bromine.

- Subjects with atopic diseases.

- Subjects who have developed any systemic allergic symptoms.

- Subjects receiving antihistamines and antiallergic agents for 1 month or more.

- Subjects receiving any of the following drugs known to affect on the action of

neuromuscular blocking agents on surgery day: calcium antagonists; anticonvulsants; aminoglycoside antibiotics; polypeptide antibiotics; or metronidazole.

- Subjects under hypothermic anesthesia.

- Subjects who participated as research subjects in another trial within the last 6

months or is now participating in other trials.

- Other subjects judged to be ineligible as subjects in this trial by the discretion of

the investigator or the sub-investigator.

Locations and Contacts

Additional Information

Starting date: June 2003
Last updated: May 11, 2015

Page last updated: August 23, 2015

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