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Efficacy, Pharmacokinetics and Safety of Org 25969 in Subjects With Normal or Impaired Renal Function (19.4.304)(P05948)(COMPLETED)

Primary Purpose

Anesthesia, General

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Sugammadex
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia, General

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA class 1 - 3 for renally impaired patients, ASA class 1-2 for control group
  • Age at least 18 years
  • Scheduled for general anesthesia without further need for muscle relaxation other than one single dose of 0.6 mg.kg-1 rocuronium
  • Scheduled for surgical procedures in the supine position
  • Written informed consent
  • Creatinine clearance (CLCR) < 30 mL/min for renally impaired group, CLCR = 80 mL/min for control group

Exclusion Criteria:

  • Known or suspected neuromuscular disorders impairing NMB
  • Known or suspected (family) history of malignant hyperthermia
  • Known or suspected allergy to narcotics, muscle relaxants or other medication used during general anesthesia
  • Use of medication known to interfere with NMBA based on the dose and the time of administration, such as antibiotics, anticonvulsants and Mg2+
  • Pregnancy
  • Childbearing potential without using any of the following methods of birth control: condom or diaphragm with spermicide, vasectomized partner ( > 6 months), intrauterine device, abstinence
  • Breast-feeding
  • Prior participation in any trial with Org 25969
  • Participation in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into trial 19.4.304, or for the UK only: Participation in another clinical trial, within 30 days of entering into trial 19.4.304.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Normal renal function

    Impaired renal function

    Arm Description

    Org 25969 given to subjects with normal renal function

    Org 25969 given to subjects with impaired renal function

    Outcomes

    Primary Outcome Measures

    Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.9

    Secondary Outcome Measures

    Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.7 and 0.8

    Full Information

    First Posted
    June 4, 2007
    Last Updated
    June 15, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00482599
    Brief Title
    Efficacy, Pharmacokinetics and Safety of Org 25969 in Subjects With Normal or Impaired Renal Function (19.4.304)(P05948)(COMPLETED)
    Official Title
    A Multicenter, Parallel Group, Comparative Trial Evaluating the Efficacy, Pharmacokinetics and Safety of Org 25969 in Subjects With Normal or Impaired Renal Function
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2005 (Actual)
    Primary Completion Date
    April 13, 2006 (Actual)
    Study Completion Date
    April 13, 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the efficacy and pharmacokinetics of Org 25969 in subjects with normal or impaired renal function and to evaluate the safety of Org 25969 in subjects with impaired renal function.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anesthesia, General

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Normal renal function
    Arm Type
    Active Comparator
    Arm Description
    Org 25969 given to subjects with normal renal function
    Arm Title
    Impaired renal function
    Arm Type
    Experimental
    Arm Description
    Org 25969 given to subjects with impaired renal function
    Intervention Type
    Drug
    Intervention Name(s)
    Sugammadex
    Other Intervention Name(s)
    Org 25969
    Intervention Description
    2 mg/kg sugammadex administered intravenously at reappearance of T2 after 0.6 mg/kg rocuronium in patients with renal impairment and control patients
    Primary Outcome Measure Information:
    Title
    Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.9
    Time Frame
    After surgery
    Secondary Outcome Measure Information:
    Title
    Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.7 and 0.8
    Time Frame
    After surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ASA class 1 - 3 for renally impaired patients, ASA class 1-2 for control group Age at least 18 years Scheduled for general anesthesia without further need for muscle relaxation other than one single dose of 0.6 mg.kg-1 rocuronium Scheduled for surgical procedures in the supine position Written informed consent Creatinine clearance (CLCR) < 30 mL/min for renally impaired group, CLCR = 80 mL/min for control group Exclusion Criteria: Known or suspected neuromuscular disorders impairing NMB Known or suspected (family) history of malignant hyperthermia Known or suspected allergy to narcotics, muscle relaxants or other medication used during general anesthesia Use of medication known to interfere with NMBA based on the dose and the time of administration, such as antibiotics, anticonvulsants and Mg2+ Pregnancy Childbearing potential without using any of the following methods of birth control: condom or diaphragm with spermicide, vasectomized partner ( > 6 months), intrauterine device, abstinence Breast-feeding Prior participation in any trial with Org 25969 Participation in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into trial 19.4.304, or for the UK only: Participation in another clinical trial, within 30 days of entering into trial 19.4.304.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20007792
    Citation
    Staals LM, Snoeck MM, Driessen JJ, van Hamersvelt HW, Flockton EA, van den Heuvel MW, Hunter JM. Reduced clearance of rocuronium and sugammadex in patients with severe to end-stage renal failure: a pharmacokinetic study. Br J Anaesth. 2010 Jan;104(1):31-9. doi: 10.1093/bja/aep340.
    Results Reference
    derived
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

    Efficacy, Pharmacokinetics and Safety of Org 25969 in Subjects With Normal or Impaired Renal Function (19.4.304)(P05948)(COMPLETED)

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