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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00984633
Recruitment Status : Completed
First Posted : September 25, 2009
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE September 24, 2009
First Posted Date  ICMJE September 25, 2009
Last Update Posted Date May 12, 2015
Study Start Date  ICMJE June 2003
Actual Primary Completion Date December 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2009)
Clinical duration of 2 doses of Org 9426 in maintenance of muscle relaxation [ Time Frame: Time from intubating dose to bolus maintenance dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Efficacy, Pharmacokinetics, and Safety of Bolus Maintenance Doses of Org 9426 (Study P05976)(COMPLETED)
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Muscle Relaxation
Intervention  ICMJE
  • Drug: Rocuronium bromide (Org 9426)
    0.6 mg/kg injection intubation dose
    Other Name: SCH 900085
  • Drug: Rocuronium bromide (Org 9426)
    0.9 mg/kg injection intubation dose
    Other Name: SCH 900085
  • Drug: Sevoflurane
    0.5-2.0% intravenous maintenance anesthesia
    Other Name: Sevofrane
  • Drug: Propofol
    4-10 mg/kg/hr maintenance anesthesia
    Other Name: Diprivan
Study Arms  ICMJE
  • Experimental: 0.6 mg/kg intubation dose + sevoflurane
    Interventions:
    • Drug: Rocuronium bromide (Org 9426)
    • Drug: Sevoflurane
  • Experimental: 0.9 mg/kg intubation dose + sevoflurane
    Interventions:
    • Drug: Rocuronium bromide (Org 9426)
    • Drug: Sevoflurane
  • Experimental: 0.6 mg/kg intubation dose + propofol
    Interventions:
    • Drug: Rocuronium bromide (Org 9426)
    • Drug: Propofol
  • Experimental: 0.9 mg/kg intubation dose + propofol
    Interventions:
    • Drug: Rocuronium bromide (Org 9426)
    • Drug: Propofol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2009)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2003
Actual Primary Completion Date December 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00984633
Other Study ID Numbers  ICMJE P05976
71102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Merck Sharp & Dohme Corp.
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP