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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00482599
First Posted: June 5, 2007
Last Update Posted: June 16, 2017
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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 Intervention Phase
Anesthesia, General Drug: Sugammadex Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

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

Enrollment: 30
Actual Study Start Date: June 1, 2005
Study Completion Date: April 13, 2006
Primary Completion Date: April 13, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
No Contacts or Locations Provided
  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 Submitted: June 4, 2007
First Posted: June 5, 2007
Last Update Posted: June 16, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases