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Completed

NCT Number: NCT00482599

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

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.

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Key information

Conditions

Anesthesia, General

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sugammadex

Drug

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 names: Org 25969

Primary outcomes

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

    Time frame: After surgery

Secondary outcomes

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

    Time frame: After surgery

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multicenter, Parallel Group, Comparative Trial Evaluating the Efficacy, Pharmacokinetics and Safety of Org 25969 in Subjects With Normal or Impaired Renal Function

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jun 5, 2007
Registry last updated
Jun 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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