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

Muscle Relaxation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00984633
• Other study ID #: P05976
• Secondary ID: 71102
• Status: Completed
• Phase: Phase 3
• First received: September 24, 2009
• Last updated: May 11, 2015
• Start date: June 2003
• Est. completion date: December 2003

Study information

• Verified date: May 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2003
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 64 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Muscle Relaxation

Intervention

Drug:
• Rocuronium bromide (Org 9426)
0.6 mg/kg injection intubation dose
• Rocuronium bromide (Org 9426)
0.9 mg/kg injection intubation dose
• Sevoflurane
0.5-2.0% intravenous maintenance anesthesia
• Propofol
4-10 mg/kg/hr maintenance anesthesia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical duration of 2 doses of Org 9426 in maintenance of muscle relaxation		Time from intubating dose to bolus maintenance dose	No