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

Phase 3

Completed

• Conditions: Anesthesia, General
• Interventions: Drug: Sugammadex

• Registration Number: NCT00482599
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06-01
• Primary Completion: 2006-04-13
• Study Completion: 2006-04-13
• Study First Submitted: 2007-06-04
• Study First Submitted QC: 2007-06-04
• Study First Posted: 2007-06-05
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-15
• Last Update Posted: 2017-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal renal function	Sugammadex	Org 25969 given to subjects with normal renal function
Impaired renal function	Sugammadex	Org 25969 given to subjects with impaired renal function

Primary Outcome Measures

Name	Time	Method
Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.9	After surgery

Secondary Outcome Measures

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