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

Anesthesia, General Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00482599
• Other study ID #: P05948
• Secondary ID: 19.4.304
• Status: Completed
• Phase: Phase 3
• First received: June 4, 2007
• Last updated: June 15, 2017
• Start date: June 1, 2005
• Est. completion date: April 13, 2006

Study information

• Verified date: June 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 13, 2006
• Est. primary completion date: April 13, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, General
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.9		After surgery
Secondary	Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.7 and 0.8		After surgery