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Efficacy, Pharmacokinetics and Safety of Org 25969 in Subjects With Normal or Impaired Renal Function (19.4.304)(P05948)(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: NCT00482599
Recruitment Status : Completed
First Posted : June 5, 2007
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Anesthesia, General Drug: Sugammadex Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 1, 2005
Primary Completion Date : April 13, 2006
Study Completion Date : April 13, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Normal renal function
Org 25969 given to subjects with normal renal function
Drug: Sugammadex
2 mg/kg sugammadex administered intravenously at reappearance of T2 after 0.6 mg/kg rocuronium in patients with renal impairment and control patients
Other Name: Org 25969
Experimental: Impaired renal function
Org 25969 given to subjects with impaired renal function
Drug: Sugammadex
2 mg/kg sugammadex administered intravenously at reappearance of T2 after 0.6 mg/kg rocuronium in patients with renal impairment and control patients
Other Name: Org 25969


Outcome Measures

Primary Outcome Measures :
  1. Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.9 [ Time Frame: After surgery ]

Secondary Outcome Measures :
  1. Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.7 and 0.8 [ Time Frame: After surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
More Information

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00482599     History of Changes
Other Study ID Numbers: P05948
19.4.304
First Posted: June 5, 2007    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases